Plaque PsoriasisSAILNCT04203693
Observational Study of Tildrakizumab in Patients With Moderate to Severe Plaque Psoriasis in Routine Clinical Practice
An observational study of Plaque Psoriasis, run by Almirall, S.A. at 41 sites in 6 countries.
Trial summary
The observational, non-interventional study will assess the efficacy, safety, prescription and utilization patterns of Tildrakizumab in participants with moderate to severe plaque psoriasis in routine clinical practice. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Plaque Psoriasis
- What is being tested?
- Tildrakizumab
- How many people
- 331 participants
- Where
- 41 sitesin 6 countries
- Study dates
- 30 Oct 2019to 2 May 2024
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult male and female patients with moderate-to-severe chronic plaque psoriasis.
Who may be able to join
- Written informed consent form.
- Age >= 18years.
- Moderate to severe chronic plaque psoriasis diagnosis.
- Participants who have participated in Tildrakizumab (Ilumetri®) clinical trials (Cohort 1) OR participants who, according to the physician's therapeutic decision, should start the treatment with Tildrakizumab (Ilumetri®) (Cohort 2).
Who cannot join
- Unable to comply with the requirements of the study or who in the opinion of the study physician should not participate in the study.
- Participants meeting any of the exclusion criteria specified in the summary of product characteristics (SmPC) of Ilumetri®.
Trial locations and contacts
41 sites in 6 countries.
41 sites in 6 countries
Germany15 sites
Investigational Site 1
Augsburg
Investigational Site 2
Berlin
Investigational Site 3
Bochum
Investigational Site 10
Cologne
Investigational Site 4
Erlangen
Investigational Site 5
Greifswald
Investigational Site 7
Halle
Investigational Site 6
Hamburg
Investigational Site 8
Kiel
Investigational Site 9
Kiel
Investigational Site 11
Lübeck
Investigational Site 13
Merzig
Investigational Site 12
München
Investigational Site 14
Oberursel
Investigational Site 15
Quedlinburg
Italy12 sites
Investigational Site 1
Arezzo
Investigational Site 2
Brescia
Investigational Site 3
Catania
Investigational Site 4
Florence
Investigational Site 5
Genova
Investigational Site 6
Lecce
Investigational Site 7
Modena
Investigational Site 10
Roma
Investigational Site 11
Roma
Investigational Site 8
Roma
Investigational Site 9
Roma
Investigational Site 12
Rozzano
Belgium9 sites
Investigator Site 1
Brussels
Investigator Site 2
Charleroi
Investigator Site 3
Genk
Investigator Site 4
Ghent
Investigator Site 5
Herstal
Investigator Site 6
Jette
Investigator Site 7
Lede
Investigator Site 8
Leuven
Investigator Site 9
Mons
About this study
Official title: Observational Study to Assess the Effectiveness, Safety Profile and Real-life Prescribing and Utilization Patterns of Tildrakizumab (Ilumetri®) in Patients With Moderate to Severe Plaque Psoriasis in Routine Clinical Practice. (SAIL)
The observational, non-interventional study will assess the efficacy, safety, prescription and utilization patterns of Tildrakizumab in participants with moderate to severe plaque psoriasis in routine clinical practice.
- Conditions
- Plaque Psoriasis
- Being tested
- Tildrakizumab
- Keywords
- Ilumetri®, Tildrakizumab, Moderate to severe plaque psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TildrakizumabDrug
The study physicians will choose the treatment independently of the enrolment in the study according to routine care.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Tildrakizumab Treated Participants | Participants will be treated with tildrakizumab who have participated in prior tildrakizumab studies Receives: Drug: Tildrakizumab | |
| Cohort 2: Newly Tildrakizumab Prescribed Participants | Participants will be newly prescribed tildrakizumab (a prescription has occurred independently of the enrolment in the study) Receives: Drug: Tildrakizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cohort 1: Absolute Psoriasis Area and Severity Index (PASI) Score at Week 48
The PASI was calculated by assessing four body regions: head (10 percent [%] of skin), arms (20%), trunk (30%), and legs (40%). For each region, the area of skin affected was estimated and graded on a scale from 0 to 6, where 0 indicated no involved area and 6 indicated 90-100% of involved area. Within each area, the severity was estimated by 3 clinical signs: erythema (redness), induration (thickness) and desquamation (scaling). Severity parameters are measured on a scale of 0 to 4, from none to maximum. The sum of all 3 severity parameters was then calculated for each section of skin, multiplied by the area score for that area and multiplied by weight of respective sections (0.1 for head, 0.2 for arms, 0.3 for body and 0.4 for legs). The range of the PASI was from 0 (no psoriasis on the body) to 72 (the most severe case of psoriasis), where higher score indicates severe outcomes.
Measured: At Week 48
Cohort 1: Absolute Psoriasis Area and Severity Index (PASI) Score at Week 96
The PASI was calculated by assessing four body regions: head (10% of skin), arms (20%), trunk (30%), and legs (40%). For each region, the area of skin affected was estimated and graded on a scale from 0 to 6, where 0 indicated no involved area and 6 indicated 90-100% of involved area. Within each area, the severity was estimated by 3 clinical signs: erythema (redness), induration (thickness) and desquamation (scaling). Severity parameters are measured on a scale of 0 to 4, from none to maximum. The sum of all 3 severity parameters was then calculated for each section of skin, multiplied by the area score for that area and multiplied by weight of respective sections (0.1 for head, 0.2 for arms, 0.3 for body and 0.4 for legs). The range of the PASI was from 0 (no psoriasis on the body) to 72 (the most severe case of psoriasis), where higher score indicates severe outcomes.
Measured: At Week 96
Cohort 1: Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 48
PASI was calculated by assessing four body regions: head (10% of skin), arms (20%), trunk (30%), and legs (40%). For each region, the area of skin affected was estimated and graded on a scale from 0 to 6, where 0 indicated no involved area and 6 indicated 90-100% of involved area. Within each area, the severity was estimated by 3 clinical signs: erythema (redness), induration (thickness) and desquamation (scaling). Severity parameters are measured on a scale of 0 to 4, from none to maximum. The sum of all 3 severity parameters was then calculated for each section of skin, multiplied by the area score for that area and multiplied by weight of respective sections (0.1 for head, 0.2 for arms, 0.3 for body and 0.4 for legs). The range of the PASI was from 0 (no psoriasis on the body) to 72 (the most severe case of psoriasis), where higher score indicates severe outcomes. Baseline defined as the last value measured on Day 0 (Week 0) prior to the first tildrakizumab administration.
Measured: Baseline (current study), Week 48
Cohort 1: Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 96
PASI was calculated by assessing four body regions: head (10% of skin), arms (20%), trunk (30%), and legs (40%). For each region, the area of skin affected was estimated and graded on a scale from 0 to 6, where 0 indicated no involved area and 6 indicated 90-100% of involved area. Within each area, the severity was estimated by 3 clinical signs: erythema (redness), induration (thickness) and desquamation (scaling). Severity parameters are measured on a scale of 0 to 4, from none to maximum. The sum of all 3 severity parameters was then calculated for each section of skin, multiplied by the area score for that area and multiplied by weight of respective sections (0.1 for head, 0.2 for arms, 0.3 for body and 0.4 for legs). The range of the PASI was from 0 (no psoriasis on the body) to 72 (the most severe case of psoriasis), where higher score indicates severe outcomes. Baseline defined as the last value measured on Day 0 (Week 0) prior to the first tildrakizumab administration.
Measured: Baseline (current study), Week 96
Cohort 1: Correlation Between Absolute Psoriasis Area and Severity Index (PASI) Scores and Dermatology Life Quality Index Adjusted for Not Relevant Responses (DLQI-R) Scores at Week 48
The PASI was calculated by assessing four body regions: head (10% of skin), arms (20%), trunk (30%), and legs (40%). The range of the PASI scale was from 0 (no psoriasis on the body) to 72 (the most severe case of psoriasis), where higher score indicates severe outcomes. The DLQI questionnaire consisted of 10 questions. Each question was scored from 0 to 3, giving a total score range from 0 (meaning no impact of skin disease on quality of life) to 30 (meaning maximum impact on quality of life), where higher score indicates severe impact on quality of life. The DLQI-R was a newly introduced variation of the regular DLQI that adjusted the total score for the number of not relevant responses and a valid scoring system for avoiding the bias of these not relevant responses of the questionnaire. Pearson correlation was performed for correlation analysis.
Measured: At Week 48
Cohort 1: Correlation Between Absolute Psoriasis Area and Severity Index Scores and Dermatology Life Quality Index Adjusted for Not Relevant Responses (DLQI-R) at Week 96
The PASI was calculated by assessing four body regions: head (10% of skin), arms (20%), trunk (30%), and legs (40%). The range of the PASI scale was from 0 (no psoriasis on the body) to 72 (the most severe case of psoriasis), where higher score indicates severe outcomes. The DLQI questionnaire consisted of 10 questions. Each question was scored from 0 to 3, giving a total score range from 0 (meaning no impact of skin disease on quality of life) to 30 (meaning maximum impact on quality of life), where higher score indicates severe impact on quality of life. The DLQI-R was a newly introduced variation of the regular DLQI that adjusted the total score for the number of not relevant responses and a valid scoring system for avoiding the bias of these not relevant responses of the questionnaire. Pearson correlation was performed for correlation analysis.
Measured: At Week 96
Cohort 1: Percentage of Participants Who Maintained Psoriasis Area and Severity Index (PASI) 75, 90, and 100 Responses at Week 48
PASI 75 and 90 defined as percentage of participants who achieved >=75% and >=90% reductions, respectively in their PASI score from baseline. PASI 100 defined as percentage of participants who have achieved a complete resolution of all disease. PASI was calculated by assessing 4 body regions: head (10% of skin), arms (20%), trunk (30%), and legs (40%). For each region, area of skin affected was estimated and graded on a scale from 0 to 6, where 0 indicated no involved area and 6 indicated 90-100% of involved area. Within each area, severity was estimated by 3 clinical signs: erythema (redness), induration (thickness) and desquamation (scaling). Severity parameters measured on a scale of 0 to 4. Sum of all 3 severity parameters was then calculated for each section of skin, multiplied by area score for that area and multiplied by weight of respective sections (0.1 for head, 0.2 for arms, 0.3 for body and 0.4 for legs). PASI range was from 0 (no psoriasis) to 72 (most severe case).
Measured: At Week 48
Cohort 1: Percentage of Participants Who Maintained Psoriasis Area and Severity Index (PASI) 75, 90, and 100 Responses at Week 96
PASI 75 and 90 defined as percentage of participants who achieved >=75% and >=90% reductions, respectively in their PASI score from baseline. PASI 100 defined as percentage of participants who achieved a complete resolution of all disease. PASI was calculated by assessing 4 body regions: head (10% of skin), arms (20%), trunk (30%), and legs (40%). For each region, area of skin affected was estimated and graded on a scale from 0 to 6, where 0 indicated no involved area and 6 indicated 90-100% of involved area. Within each area, severity was estimated by 3 clinical signs: erythema (redness), induration (thickness) and desquamation (scaling). Severity parameters measured on a scale of 0 to 4. Sum of all 3 severity parameters was then calculated for each section of skin, multiplied by area score for that area and multiplied by weight of respective sections (0.1 for head, 0.2 for arms, 0.3 for body and 0.4 for legs). PASI range was from 0 (no psoriasis) to 72 (most severe case).
Measured: At Week 96
Cohort 1: Percentage of Absolute Body Surface Area Affected by Psoriasis (BSA) at Week 48
The BSA measures the total area of the body affected by psoriasis assessed by the study physician in terms of percentage.
Measured: At Week 48
Cohort 1: Percentage of Absolute Body Surface Area Affected by Psoriasis (BSA) at Week 96
The BSA measures the total area of the body affected by psoriasis assessed by the study physician in terms of percentage.
Measured: At Week 96
Cohort 1: Change From Baseline of reSURFACE Study in Percentage of Body Surface Area (BSA) Affected by Psoriasis at Week 48
The BSA measures the total area of the body affected by psoriasis assessed by the study physician in terms of percentage. Baseline value of reSURFACE Studies was used to calculate change at Week 48 of current study. Baseline defined as the last value measured on Day 0 (Week 0) prior to the first tildrakizumab administration (also if participant participated in tildrakizumab [reSURFACE] clinical trials).
Measured: Baseline (Day 0 of reSURFACE Studies), Week 48 (Current study)
Cohort 1: Change From Baseline of reSURFACE Study in Percentage of Body Surface Area (BSA) Affected by Psoriasis at Week 96
The BSA measures the total area of the body affected by psoriasis assessed by the study physician in terms of percentage. Baseline value of reSURFACE Studies was used to calculate change at Week 96 of current study. Baseline defined as the last value measured on Day 0 (Week 0) prior to the first tildrakizumab administration (also if participant participated in tildrakizumab [reSURFACE] clinical trials).
Measured: Baseline (Day 0 of reSURFACE Studies), Week 96 (Current Study)
Cohort 1: Absolute Physician's Global Assessment (PGA) (General, Nail, Scalp) Scores at Week 48
The PGA is a 5-point measure of psoriasis. The PGA of psoriasis of the whole body (general), scalp and nail were made on a 5-point scale ranged from 0 to 4, where 0 = none (clear); 1 = minimal; 2 = mild; 3 = moderate; 4 = severe. The higher score indicates severe outcomes.
Measured: At Week 48
Cohort 1: Absolute Physician's Global Assessment (PGA) (General, Nail, Scalp) Scores at Week 96
The PGA is a 5-point measure of psoriasis. The PGA of psoriasis of the whole body (general), scalp and nail were made on a 5-point scale ranged from 0 to 4, where 0 = none (clear); 1 = minimal; 2 = mild; 3 = moderate; 4 = severe. The higher score indicates severe outcomes.
Measured: At Week 96
Cohort 1: Change From Baseline (reSURFACE Studies for General and Current Study for Nail and Scalp) in Physician's Global Assessment (PGA) Score at Week 48
The PGA is a 5-point measure of psoriasis. The PGA of psoriasis of the whole body (general), scalp and nail were made on a 5-point scale ranged from 0 to 4, where 0 = none (clear); 1 = minimal; 2 = mild; 3 = moderate; 4 = severe. The higher score indicates severe outcomes. Baseline value of reSURFACE Studies was used to calculate change for "General" at Week 48 of current study. For "Nail" and "Scalp", Baseline value of current study was used to calculate change. Baseline defined as the last value measured on Day 0 (Week 0) prior to the first tildrakizumab administration (also if participant participated in tildrakizumab [reSURFACE] clinical trials).
Measured: Baseline (Day 0 of reSURFACE Studies for General and current study for Nail and Scalp), Week 48 (Current Study)
Cohort 1: Change From Baseline (reSURFACE Studies for General and Current Study for Nail and Scalp) in Physician's Global Assessment (PGA) Score at Week 96
The PGA is a 5-point measure of psoriasis. The PGA of psoriasis of the whole body (general), scalp and nail were made on a 5-point scale ranged from 0 to 4, where 0 = none (clear); 1 = minimal; 2 = mild; 3 = moderate; 4 = severe. The higher score indicates severe outcomes. Baseline value of reSURFACE Studies was used to calculate change for "General" at Week 96 of current study. For "Nail" and "Scalp", Baseline value of current study was used to calculate change. Baseline defined as the last value measured on Day 0 (Week 0) prior to the first tildrakizumab administration (also if participant participated in tildrakizumab [reSURFACE] clinical trials).
Measured: Baseline (Day 0 of reSURFACE Studies for General and current study for Nail and Scalp), Week 96 (Current study)
Cohort 2: Absolute Psoriasis Area and Severity Index (PASI) Score at Week 52
The PASI was calculated by assessing four body regions: head (10% of skin), arms (20%), trunk (30%), and legs (40%). For each region, the area of skin affected was estimated and graded on a scale from 0 to 6, where 0 indicated no involved area and 6 indicated 90-100% of involved area. Within each area, the severity was estimated by 3 clinical signs: erythema (redness), induration (thickness) and desquamation (scaling). Severity parameters are measured on a scale of 0 to 4, from none to maximum. The sum of all 3 severity parameters was then calculated for each section of skin, multiplied by the area score for that area and multiplied by weight of respective sections (0.1 for head, 0.2 for arms, 0.3 for body and 0.4 for legs). The range of the PASI was from 0 (no psoriasis on the body) to 72 (the most severe case of psoriasis), where higher score indicates severe outcomes.
Measured: At Week 52
Cohort 2: Absolute Psoriasis Area and Severity Index (PASI) Scroe at Week 100
The PASI was calculated by assessing four body regions: head (10% of skin), arms (20%), trunk (30%), and legs (40%). For each region, the area of skin affected was estimated and graded on a scale from 0 to 6, where 0 indicated no involved area and 6 indicated 90-100% of involved area. Within each area, the severity was estimated by 3 clinical signs: erythema (redness), induration (thickness) and desquamation (scaling). Severity parameters are measured on a scale of 0 to 4, from none to maximum. The sum of all 3 severity parameters was then calculated for each section of skin, multiplied by the area score for that area and multiplied by weight of respective sections (0.1 for head, 0.2 for arms, 0.3 for body and 0.4 for legs). The range of the PASI was from 0 (no psoriasis on the body) to 72 (the most severe case of psoriasis), where higher score indicates severe outcomes.
Measured: At Week 100
Cohort 2: Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 52
The PASI was calculated by assessing four body regions: head (10% of skin), arms (20%), trunk (30%), and legs (40%). For each region, the area of skin affected was estimated and graded on a scale from 0 to 6, where 0 indicated no involved area and 6 indicated 90-100% of involved area. Within each area, the severity was estimated by 3 clinical signs: erythema (redness), induration (thickness) and desquamation (scaling). Severity parameters are measured on a scale of 0 to 4, from none to maximum. The sum of all 3 severity parameters was then calculated for each section of skin, multiplied by the area score for that area and multiplied by weight of respective sections (0.1 for head, 0.2 for arms, 0.3 for body and 0.4 for legs). The range of the PASI was from 0 (no psoriasis on the body) to 72 (the most severe case of psoriasis), where higher score indicates severe outcomes. Baseline defined as the last value measured on Day 0 (Week 0) prior to the first tildrakizumab administration.
Measured: Baseline (current study), Week 52
Cohort 2: Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 100
The PASI was calculated by assessing four body regions: head (10% of skin), arms (20%), trunk (30%), and legs (40%). For each region, the area of skin affected was estimated and graded on a scale from 0 to 6, where 0 indicated no involved area and 6 indicated 90-100% of involved area. Within each area, the severity was estimated by 3 clinical signs: erythema (redness), induration (thickness) and desquamation (scaling). Severity parameters are measured on a scale of 0 to 4, from none to maximum. The sum of all 3 severity parameters was then calculated for each section of skin, multiplied by the area score for that area and multiplied by weight of respective sections (0.1 for head, 0.2 for arms, 0.3 for body and 0.4 for legs). The range of the PASI was from 0 (no psoriasis on the body) to 72 (the most severe case of psoriasis), where higher score indicates severe outcomes. Baseline defined as the last value measured on Day 0 (Week 0) prior to the first tildrakizumab administration.
Measured: Baseline (current study), Week 100
Cohort 2: Correlation Between Absolute Psoriasis Area and Severity Index (PASI) Scores and Dermatology Life Quality Index Adjusted for Not Relevant Responses (DLQI-R) at Week 52
The PASI was calculated by assessing four body regions: head (10% of skin), arms (20%), trunk (30%), and legs (40%). The range of the PASI scale was from 0 (no psoriasis on the body) to 72 (the most severe case of psoriasis), where higher score indicates severe outcomes. The DLQI questionnaire consisted of 10 questions. Each question was scored from 0 to 3, giving a total score range from 0 (meaning no impact of skin disease on quality of life) to 30 (meaning maximum impact on quality of life), where higher score indicates severe impact on quality of life. The DLQI-R was a newly introduced variation of the regular DLQI that adjusted the total score for the number of not relevant responses and a valid scoring system for avoiding the bias of these not relevant responses of the questionnaire. Pearson correlation was performed for correlation analysis.
Measured: At Week 52
Cohort 2: Correlation Between Absolute Psoriasis Area and Severity Index (PASI) Scores and Dermatology Life Quality Index Adjusted for Not Relevant Responses (DLQI-R) at Week 100
The PASI was calculated by assessing four body regions: head (10% of skin), arms (20%), trunk (30%), and legs (40%). The range of the PASI scale was from 0 (no psoriasis on the body) to 72 (the most severe case of psoriasis), where higher score indicates severe outcomes. The DLQI questionnaire consisted of 10 questions. Each question was scored from 0 to 3, giving a total score range from 0 (meaning no impact of skin disease on quality of life) to 30 (meaning maximum impact on quality of life), where higher score indicates severe impact on quality of life. The DLQI-R was a newly introduced variation of the regular DLQI that adjusted the total score for the number of not relevant responses and a valid scoring system for avoiding the bias of these not relevant responses of the questionnaire. Pearson correlation was performed for correlation analysis.
Measured: At Week 100
Cohort 2: Percentage of Participants Who Maintained Psoriasis Area and Severity Index (PASI) 75, 90, and 100 Responses at Week 52
PASI 75 and 90 defined as percentage of participants who achieved >=75% and >=90% reductions, respectively in their PASI score from baseline. PASI 100 defined as percentage of participants who have achieved a complete resolution of all disease. PASI was calculated by assessing 4 body regions: head (10% of skin), arms (20%), trunk (30%), and legs (40%). For each region, area of skin affected was estimated and graded on a scale from 0 to 6, where 0 indicated no involved area and 6 indicated 90-100% of involved area. Within each area, severity was estimated by 3 clinical signs: erythema (redness), induration (thickness) and desquamation (scaling). Severity parameters measured on a scale of 0 to 4. Sum of all 3 severity parameters was then calculated for each section of skin, multiplied by area score for that area and multiplied by weight of respective sections (0.1 for head, 0.2 for arms, 0.3 for body and 0.4 for legs). PASI range was from 0 (no psoriasis) to 72 (most severe case).
Measured: At Week 52
Cohort 2: Percentage of Participants Who Maintained Psoriasis Area and Severity Index (PASI) 75, 90, and 100 Responses at Week 100
PASI 75 and 90 defined as percentage of participants who achieved >=75% and >=90% reductions, respectively in their PASI score from baseline. PASI 100 defined as percentage of participants who achieved a complete resolution of all disease. PASI was calculated by assessing 4 body regions: head (10% of skin), arms (20%), trunk (30%), and legs (40%). For each region, area of skin affected was estimated and graded on a scale from 0 to 6, where 0 indicated no involved area and 6 indicated 90-100% of involved area. Within each area, severity was estimated by 3 clinical signs: erythema (redness), induration (thickness) and desquamation (scaling). Severity parameters measured on a scale of 0 to 4. Sum of all 3 severity parameters was then calculated for each section of skin, multiplied by area score for that area and multiplied by weight of respective sections (0.1 for head, 0.2 for arms, 0.3 for body and 0.4 for legs). PASI range was from 0 (no psoriasis) to 72 (most severe case).
Measured: At Week 100
Cohort 2: Percentage of Absolute Body Surface Area Affected by Psoriasis (BSA) at Week 52
The BSA measures the total area of the body affected by psoriasis assessed by the study physician in terms of percentage.
Measured: At Week 52
Cohort 2: Percentage of Absolute Body Surface Area Affected by Psoriasis (BSA) at Week 100
The BSA measures the total area of the body affected by psoriasis assessed by the study physician in terms of percentage.
Measured: At Week 100
Cohort 2: Change From Baseline in Percentage of Body Surface Area (BSA) Affected by Psoriasis at Week 52
The BSA measures the total area of the body affected by psoriasis assessed by the study physician in terms of percentage. Baseline defined as the last value measured on Day 0 (Week 0) prior to the first tildrakizumab administration.
Measured: Baseline (current study), Week 52
Cohort 2: Change From Baseline in Percentage of Body Surface Area (BSA) Affected by Psoriasis at Week 100
The BSA measures the total area of the body affected by psoriasis assessed by the study physician in terms of percentage. Baseline defined as the last value measured on Day 0 (Week 0) prior to the first tildrakizumab administration.
Measured: Baseline (current study), Week 100
Cohort 2: Absolute Physician's Global Assessment (PGA) (General, Nail and Scalp) Scores at Week 52
The PGA is a 5-point measure of psoriasis. The PGA of psoriasis of the whole body (general), scalp and nail were made on a 5-point scale ranged from 0 to 4, where 0 = none (clear); 1 = minimal; 2 = mild; 3 = moderate; 4 = severe. The higher score indicates severe outcomes.
Measured: At Week 52
Cohort 2: Absolute Physician's Global Assessment (PGA) (General, Nail and Scalp) Scores at Week 100
The PGA is a 5-point measure of psoriasis. The PGA of psoriasis of the whole body (general), scalp and nail were made on a 5-point scale ranged from 0 to 4, where 0 = none (clear); 1 = minimal; 2 = mild; 3 = moderate; 4 = severe. The higher score indicates severe outcomes.
Measured: At Week 100
Cohort 2: Change From Baseline in Physician's Global Assessment (PGA) (General, Nail and Scalp) Scores at Week 52
The PGA is a 5-point measure of psoriasis. The PGA of psoriasis of the whole body (general), scalp and nail were made on a 5-point scale ranged from 0 to 4, where 0 = none (clear); 1 = minimal; 2 = mild; 3 = moderate; 4 = severe. The higher score indicates severe outcomes. Baseline defined as the last value measured on Day 0 (Week 0) prior to the first tildrakizumab administration.
Measured: Baseline (current study), Week 52
Cohort 2: Change From Baseline in Physician's Global Assessment (PGA) (General, Nail and Scalp) Scores at Week 100
The PGA is a 5-point measure of psoriasis. The PGA of psoriasis of the whole body (general), scalp and nail were made on a 5-point scale ranged from 0 to 4, where 0 = none (clear); 1 = minimal; 2 = mild; 3 = moderate; 4 = severe. The higher score indicates severe outcomes. Baseline defined as the last value measured on Day 0 (Week 0) prior to the first tildrakizumab administration.
Measured: Baseline (current study), Week 100
Secondary outcomes (23)
Absolute Dermatology Life Quality Index (DLQI) Score at Week 48 and Week 96 for Cohort 1 and Week 52 and Week 100 for Cohort 2
The DLQI questionnaire consisted of 10 questions. Each question was scored from 0 to 3, giving a total score range from 0 (meaning no impact of skin disease on quality of life) to 30 (meaning maximum impact on quality of life), where higher score indicates severe impact on quality of life.
Measured: Cohort 1: Week 48 and Week 96; Cohort 2: Week 52 and Week 100
Change From Baseline in Absolute Dermatology Life Quality Index (DLQI) Score at Week 48 and Week 96 for Cohort 1 and Week 52 and Week 100 for Cohort 2
The DLQI questionnaire consisted of 10 questions. Each question was scored from 0 to 3, giving a total score range from 0 (meaning no impact of skin disease on quality of life) to 30 (meaning maximum impact on quality of life), where higher score indicates severe impact on quality of life. Baseline defined as the last value measured on Day 0 (Week 0) prior to the first tildrakizumab administration.
Measured: Cohort 1: Baseline (current study), Week 48 and Week 96; Cohort 2: Baseline (current study), Week 52 and Week 100
Absolute Dermatology Life Quality Index Score Adjusted for Not Relevant Responses (DLQI-R) at Week 48 and Week 96 for Cohort 1 and Week 52 and Week 100 for Cohort 2
The DLQI questionnaire consisted of 10 questions. Each question was scored from 0 to 3, giving a total score range from 0 (meaning no impact of skin disease on quality of life) to 30 (meaning maximum impact on quality of life), where higher score indicates severe impact on quality of life. The DLQI-R was a newly introduced variation of the regular DLQI that adjusted the total score for the number of not relevant responses and a valid scoring system for avoiding the bias of these not relevant responses of the questionnaire.
Measured: Cohort 1: Week 48 and Week 96; Cohort 2: Week 52 and Week 100
Change From Baseline in Dermatology Life Quality Index Score Adjusted for Not Relevant Responses at Week 48 and Week 96 for Cohort 1 and Week 52 and Week 100 for Cohort 2
The DLQI questionnaire consisted of 10 questions. Each question was scored from 0 to 3, giving a total score range from 0 (meaning no impact of skin disease on quality of life) to 30 (meaning maximum impact on quality of life), where higher score indicates severe impact on quality of life. The DLQI-R was a newly introduced variation of the regular DLQI that adjusted the total score for the number of not relevant responses and a valid scoring system for avoiding the bias of these not relevant responses of the questionnaire. Baseline defined as the last value measured on Day 0 (Week 0) prior to the first tildrakizumab administration.
Measured: Cohort 1: Baseline (current study), Week 48 and Week 96; Cohort 2: Baseline (current study), Week 52 and Week 100
Itch and Pain Visual Analogue Scales (VAS) Scores at Week 96 for Cohort 1 and Week 100 for Cohort 2
Itch and pain of the skin were assessed by the participants on visual analogue scales (VAS) score ranged from 0 to 100, where 0 represented the best possible condition ("no itching" and "no skin pain", respectively) and 100 the worst possible condition ("worst itch imaginable" and "severe skin pain", respectively). Higher score indicates worse outcome.
Measured: Cohort 1: At Week 96; Cohort 2: At Week 100
Change From Baseline in Itch and Pain Visual Analogue Scales (VAS) Scores at Week 96 for Cohort 1 and Week 100 for Cohort 2
Itch and pain of the skin were assessed by the participants on visual analogue scales (VAS) score ranged from 0 to 100, where 0 represented the best possible condition ("no itching" and "no skin pain", respectively) and 100 the worst possible condition ("worst itch imaginable" and "severe skin pain", respectively). Higher score indicates worse outcome. Baseline defined as the last value measured on Day 0 (Week 0) prior to the first tildrakizumab administration.
Measured: Cohort 1: At Week 96; Cohort 2: At Week 100
Absolute Scores of Participant's Satisfaction With Tildrakizumab Therapy as Assessed by Treatment Satisfaction Questionnaire for Medication (TSQM) at Week 96 for Cohort 1 and Week 100 for Cohort 2
TSQM Version 1.4 was used to determine participant´s satisfaction with the tildrakizumab (Ilumetri®) therapy. This questionnaire was comprised of 14 items which represented the following four domains:(1) Effectiveness (3 items, Question [Q]1-Q3); (2) Side effects (5 items, Q4-Q8); (3) Convenience (3 items, Q9-Q11); (4) Global satisfaction (3 items, Q12-Q14). TSQM scores for the each domain ranged from 0 to 100, higher scores indicate greater satisfaction.
Measured: Cohort 1: At Week 96; Cohort 2: At Week 100
Absolute Scores of Physician's Satisfaction With Tildrakizumab Therapy for Effectiveness and Tolerability at Week 96 for Cohort 1 and Week 100 for Cohort 2
The effectiveness and tolerability of tildrakizumab (Ilumetri®) were rated on a 4-point scale ranging over 1 to 4, where 1 = "very good", 2 = "good", 3 = "acceptable" and 4 = "bad". The higher score means no or bad satisfaction.
Measured: Cohort 1: At Week 96; Cohort 2: At Week 100
Number of Participants Who Added Concomitant Medications
Number of participants who added concomitant medications were reported.
Measured: Cohort 1: Baseline (current study) up to Week 96; Cohort 2: Baseline (current study) up to Week 100
Change From Baseline in Body Weight up to Week 96 for Cohort 1 and Week 100 for Cohort 2
Change from baseline in body weight at Week 96 for Cohort 1 and Week 100 for Cohort 2 was reported. Baseline defined as the last value measured on Day 0 (Week 0) prior to the first tildrakizumab administration.
Measured: Cohort 1: Baseline (current study) up to Week 96; Cohort 2: Baseline (current study) up to Week 100
Change From Baseline in Waist and Hip Circumference at Week 96 for Cohort 1 and Week 100 for Cohort 2
Change from baseline in waist and hip circumference at Week 96 for Cohort 1 and Week 100 for Cohort 2 were reported. Baseline defined as the last value measured on Day 0 (Week 0) prior to the first tildrakizumab administration.
Measured: Cohort 1: Baseline (current study), Week 96; Cohort 2: Baseline (current study), Week 100
Change From Baseline in Waist/Hip Ratio at Week 96 for Cohort 1 and Week 100 for Cohort 2
Change from baseline in waist/hip ratio at Week 96 for Cohort 1 and Week 100 for Cohort 2 were reported. Baseline defined as the last value measured on Day 0 (Week 0) prior to the first tildrakizumab administration.
Measured: Cohort 1: Baseline (current study), Week 96; Cohort 2: Baseline (current study), Week 100
Change From Baseline in Body Mass Index (BMI) at Week 96 for Cohort 1 and Week 100 for Cohort 2
Change from baseline in BMI at Week 96 for Cohort 1 and Week 100 for Cohort 2 were reported. Baseline defined as the last value measured on Day 0 (Week 0) prior to the first tildrakizumab administration.
Measured: Cohort 1: Baseline (current study), Week 96; Cohort 2: Baseline (current study), Week 100
Change From Baseline in Systolic and Diastolic Blood Pressure (BP) at Week 96 for Cohort 1 and Week 100 for Cohort 2
Change from baseline in systolic and diastolic BP at Week 96 for Cohort 1 and Week 100 for Cohort 2 were reported. Baseline defined as the last value measured on Day 0 (Week 0) prior to the first tildrakizumab administration.
Measured: Cohort 1: Baseline (current study), Week 96; Cohort 1: Baseline (current study), Week 100
Number of Participants With Responses to Questions About Food Intake
Participants were asked to complete a simple questionnaire regarding their food intake, which included the following questions: 1. Do you limit yourself in calorie intake; 2. Do you follow any other kind of diet; 3. Do you have any food intolerance; 4. Do you have any food allergy.
Measured: Cohort 1: Baseline (current study) up to Week 96; Cohort 2: Baseline (current study) up to Week 100
Number of Participants With Responses to Physical Activity Questionnaire
Participants were asked to complete a simple questionnaire regarding their physical activity i.e. Workout (e.g. aerobic activity), Weight training (exercises in the gym) and Stretch exercise e.g. Yoga. Number of participants With Responses to Physical Activity Questionnaire were reported.
Measured: Cohort 1: Baseline (current study) up to Week 96; Cohort 2: Baseline (current study) up to Week 100
Change From Baseline in Physical Activity at Week 96 for Cohort 1 and Week 100 for Cohort 2
Exercise time of workout, weight training and stretch exercise was calculated in total minutes per month as: Minutes of exercise per day * Number of days in the month. Baseline defined as the last value measured on Day 0 (Week 0) prior to the first tildrakizumab administration.
Measured: Cohort 1: Baseline (current study), Week 96; Cohort 2: Baseline (current study), Week 100
Change From Baseline in Lipid Profiles at Week 96 for Cohort 1 and Week 100 for Cohort 2
Change from baseline in lipid profiles (total cholesterol, high-density lipoprotein cholesterol [HDL-c], low-density lipoprotein cholesterol [LDL-c], Triglycerides [TG]) at Week 96 for Cohort 1 and Week 100 for Cohort 2 were reported. Baseline defined as the last value measured on Day 0 (Week 0) prior to the first tildrakizumab administration.
Measured: Cohort 1: Baseline (current study), Week 96; Cohort 1: Baseline (current study), Week 100
Change From Baseline in Lipid Profile (Lipoprotein-a) at Week 96 for Cohort 1 and Week 100 for Cohort 2
Change from baseline in lipid profile (lipoprotein-a) at Week 96 for Cohort 1 and Week 100 for Cohort 2 were reported. Baseline defined as the last value measured on Day 0 (Week 0) prior to the first tildrakizumab administration.
Measured: Cohort 1: Baseline (current study), Week 96; Cohort 1: Baseline (current study), Week 100
Number of Participants Withdrawn From the Study
Number of participants withdrawn from the study due to any reason were reported.
Measured: Cohort 1: Baseline (current study) up to Week 96; Cohort 2: Baseline (current study) up to Week 100
Number of Participants With Reason for Tildrakizumab Dosage Change
Number of participants with reasons of tildrakizumab change (100 mg or 200 mg) were reported.
Measured: Cohort 1: At Week 84; Cohort 2: At Week 100
Drug Survival
Drug survival was defined as the time to study drug discontinuation. The time to discontinuation of the study drug (months) was measured from the (first dosing date to the last dosing date)/30.5.
Measured: Cohort 1: Baseline (current study) up to Week 96; Cohort 2: Baseline (current study) up to Week 100
Participants Adherence as Assessed by Time to Study Discontinuation
Time to study discontinuation was defined as: (first dosing date to the study completion date or decided to discontinue date)/30.5.
Measured: Cohort 1: Baseline (current study) up to Week 96; Cohort 2: Baseline (current study) up to Week 100
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2019
- Study start30 Oct 2019
- Primary completion2 May 2024
- Study completion2 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Plaque PsoriasisStudies of the same condition, open and under way.
- More trials run by Almirall, S.A.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 331 participants (actual)
Sponsor and investigators
- Lead sponsor
- Almirall, S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Almirall, S.A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04203693
- Sponsor's protocol ID
- NIS Study M-14745-43
- Acronym
- SAIL
- Status last verified
- Feb 2026
- First submitted
- 10 Dec 2019
- Last updated
- 2 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study to Assess the Effectiveness, Safety Profile and Real-life Prescribing and Utilization Patterns of Tildrakizumab (Ilumetri®) in Patients With Moderate to Severe Plaque Psoriasis in Routine Clinical Practice. (SAIL)
- ClinicalTrials.gov ID
- NCT04203693
- Acronym / sponsor ID
- SAIL / NIS Study M-14745-43
- Conditions
- Plaque Psoriasis
- Keywords
- Ilumetri®, Tildrakizumab, Moderate to severe plaque psoriasis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 331 participants (actual)
- Lead sponsor
- Almirall, S.A.Industry (pharma, biotech, devices)
- Study start
- 30 Oct 2019 (actual)
- Primary completion
- 2 May 2024 (actual)
- Study completion
- 2 May 2024 (actual)
- First posted
- 18 Dec 2019 (actual)
- Results
- Posted 2 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The observational, non-interventional study will assess the efficacy, safety, prescription and utilization patterns of Tildrakizumab in participants with moderate to severe plaque psoriasis in routine clinical practice.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Tildrakizumab Treated Participants | – | Drug: TildrakizumabParticipants will be treated with tildrakizumab who have participated in prior tildrakizumab studies |
| Cohort 2: Newly Tildrakizumab Prescribed Participants | – | Drug: TildrakizumabParticipants will be newly prescribed tildrakizumab (a prescription has occurred independently of the enrolment in the study) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult male and female patients with moderate-to-severe chronic plaque psoriasis.
Key inclusion criteria (4 listed)
- Written informed consent form.
- Age >= 18years.
- Moderate to severe chronic plaque psoriasis diagnosis.
- Participants who have participated in Tildrakizumab (Ilumetri®) clinical trials (Cohort 1) OR participants who, according to the physician's therapeutic decision, should start the treatment with Tildrakizumab (Ilumetri®) (Cohort 2).
Key exclusion criteria (2 listed)
- Unable to comply with the requirements of the study or who in the opinion of the study physician should not participate in the study.
- Participants meeting any of the exclusion criteria specified in the summary of product characteristics (SmPC) of Ilumetri®.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TildrakizumabThe study physicians will choose the treatment independently of the enrolment in the study according to routine care. | Drug | Cohort 1: Tildrakizumab Treated Participants, Cohort 2: Newly Tildrakizumab Prescribed Participants |
Primary outcome
Cohort 1: Absolute Psoriasis Area and Severity Index (PASI) Score at Week 48
Time frame: At Week 48
The PASI was calculated by assessing four body regions: head (10 percent [%] of skin), arms (20%), trunk (30%), and legs (40%). For each region, the area of skin affected was estimated and graded on a scale from 0 to 6, where 0 indicated no involved area and 6 indicated 90-100% of involved area. Within each area, the severity was estimated by 3 clinical signs: erythema (redness), induration (thickness) and desquamation (scaling). Severity parameters are measured on a scale of 0 to 4, from none to maximum. The sum of all 3 severity parameters was then calculated for each section of skin, multiplied by the area score for that area and multiplied by weight of respective sections (0.1 for head, 0.2 for arms, 0.3 for body and 0.4 for legs). The range of the PASI was from 0 (no psoriasis on the body) to 72 (the most severe case of psoriasis), where higher score indicates severe outcomes.
Cohort 1: Absolute Psoriasis Area and Severity Index (PASI) Score at Week 96
Time frame: At Week 96
The PASI was calculated by assessing four body regions: head (10% of skin), arms (20%), trunk (30%), and legs (40%). For each region, the area of skin affected was estimated and graded on a scale from 0 to 6, where 0 indicated no involved area and 6 indicated 90-100% of involved area. Within each area, the severity was estimated by 3 clinical signs: erythema (redness), induration (thickness) and desquamation (scaling). Severity parameters are measured on a scale of 0 to 4, from none to maximum. The sum of all 3 severity parameters was then calculated for each section of skin, multiplied by the area score for that area and multiplied by weight of respective sections (0.1 for head, 0.2 for arms, 0.3 for body and 0.4 for legs). The range of the PASI was from 0 (no psoriasis on the body) to 72 (the most severe case of psoriasis), where higher score indicates severe outcomes.
Cohort 1: Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 48
Time frame: Baseline (current study), Week 48
PASI was calculated by assessing four body regions: head (10% of skin), arms (20%), trunk (30%), and legs (40%). For each region, the area of skin affected was estimated and graded on a scale from 0 to 6, where 0 indicated no involved area and 6 indicated 90-100% of involved area. Within each area, the severity was estimated by 3 clinical signs: erythema (redness), induration (thickness) and desquamation (scaling). Severity parameters are measured on a scale of 0 to 4, from none to maximum. The sum of all 3 severity parameters was then calculated for each section of skin, multiplied by the area score for that area and multiplied by weight of respective sections (0.1 for head, 0.2 for arms, 0.3 for body and 0.4 for legs). The range of the PASI was from 0 (no psoriasis on the body) to 72 (the most severe case of psoriasis), where higher score indicates severe outcomes. Baseline defined as the last value measured on Day 0 (Week 0) prior to the first tildrakizumab administration.
Cohort 1: Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 96
Time frame: Baseline (current study), Week 96
PASI was calculated by assessing four body regions: head (10% of skin), arms (20%), trunk (30%), and legs (40%). For each region, the area of skin affected was estimated and graded on a scale from 0 to 6, where 0 indicated no involved area and 6 indicated 90-100% of involved area. Within each area, the severity was estimated by 3 clinical signs: erythema (redness), induration (thickness) and desquamation (scaling). Severity parameters are measured on a scale of 0 to 4, from none to maximum. The sum of all 3 severity parameters was then calculated for each section of skin, multiplied by the area score for that area and multiplied by weight of respective sections (0.1 for head, 0.2 for arms, 0.3 for body and 0.4 for legs). The range of the PASI was from 0 (no psoriasis on the body) to 72 (the most severe case of psoriasis), where higher score indicates severe outcomes. Baseline defined as the last value measured on Day 0 (Week 0) prior to the first tildrakizumab administration.
Cohort 1: Correlation Between Absolute Psoriasis Area and Severity Index (PASI) Scores and Dermatology Life Quality Index Adjusted for Not Relevant Responses (DLQI-R) Scores at Week 48
Time frame: At Week 48
The PASI was calculated by assessing four body regions: head (10% of skin), arms (20%), trunk (30%), and legs (40%). The range of the PASI scale was from 0 (no psoriasis on the body) to 72 (the most severe case of psoriasis), where higher score indicates severe outcomes. The DLQI questionnaire consisted of 10 questions. Each question was scored from 0 to 3, giving a total score range from 0 (meaning no impact of skin disease on quality of life) to 30 (meaning maximum impact on quality of life), where higher score indicates severe impact on quality of life. The DLQI-R was a newly introduced variation of the regular DLQI that adjusted the total score for the number of not relevant responses and a valid scoring system for avoiding the bias of these not relevant responses of the questionnaire. Pearson correlation was performed for correlation analysis.
Cohort 1: Correlation Between Absolute Psoriasis Area and Severity Index Scores and Dermatology Life Quality Index Adjusted for Not Relevant Responses (DLQI-R) at Week 96
Time frame: At Week 96
The PASI was calculated by assessing four body regions: head (10% of skin), arms (20%), trunk (30%), and legs (40%). The range of the PASI scale was from 0 (no psoriasis on the body) to 72 (the most severe case of psoriasis), where higher score indicates severe outcomes. The DLQI questionnaire consisted of 10 questions. Each question was scored from 0 to 3, giving a total score range from 0 (meaning no impact of skin disease on quality of life) to 30 (meaning maximum impact on quality of life), where higher score indicates severe impact on quality of life. The DLQI-R was a newly introduced variation of the regular DLQI that adjusted the total score for the number of not relevant responses and a valid scoring system for avoiding the bias of these not relevant responses of the questionnaire. Pearson correlation was performed for correlation analysis.
Cohort 1: Percentage of Participants Who Maintained Psoriasis Area and Severity Index (PASI) 75, 90, and 100 Responses at Week 48
Time frame: At Week 48
PASI 75 and 90 defined as percentage of participants who achieved >=75% and >=90% reductions, respectively in their PASI score from baseline. PASI 100 defined as percentage of participants who have achieved a complete resolution of all disease. PASI was calculated by assessing 4 body regions: head (10% of skin), arms (20%), trunk (30%), and legs (40%). For each region, area of skin affected was estimated and graded on a scale from 0 to 6, where 0 indicated no involved area and 6 indicated 90-100% of involved area. Within each area, severity was estimated by 3 clinical signs: erythema (redness), induration (thickness) and desquamation (scaling). Severity parameters measured on a scale of 0 to 4. Sum of all 3 severity parameters was then calculated for each section of skin, multiplied by area score for that area and multiplied by weight of respective sections (0.1 for head, 0.2 for arms, 0.3 for body and 0.4 for legs). PASI range was from 0 (no psoriasis) to 72 (most severe case).
Cohort 1: Percentage of Participants Who Maintained Psoriasis Area and Severity Index (PASI) 75, 90, and 100 Responses at Week 96
Time frame: At Week 96
PASI 75 and 90 defined as percentage of participants who achieved >=75% and >=90% reductions, respectively in their PASI score from baseline. PASI 100 defined as percentage of participants who achieved a complete resolution of all disease. PASI was calculated by assessing 4 body regions: head (10% of skin), arms (20%), trunk (30%), and legs (40%). For each region, area of skin affected was estimated and graded on a scale from 0 to 6, where 0 indicated no involved area and 6 indicated 90-100% of involved area. Within each area, severity was estimated by 3 clinical signs: erythema (redness), induration (thickness) and desquamation (scaling). Severity parameters measured on a scale of 0 to 4. Sum of all 3 severity parameters was then calculated for each section of skin, multiplied by area score for that area and multiplied by weight of respective sections (0.1 for head, 0.2 for arms, 0.3 for body and 0.4 for legs). PASI range was from 0 (no psoriasis) to 72 (most severe case).
Cohort 1: Percentage of Absolute Body Surface Area Affected by Psoriasis (BSA) at Week 48
Time frame: At Week 48
The BSA measures the total area of the body affected by psoriasis assessed by the study physician in terms of percentage.
Cohort 1: Percentage of Absolute Body Surface Area Affected by Psoriasis (BSA) at Week 96
Time frame: At Week 96
The BSA measures the total area of the body affected by psoriasis assessed by the study physician in terms of percentage.
Cohort 1: Change From Baseline of reSURFACE Study in Percentage of Body Surface Area (BSA) Affected by Psoriasis at Week 48
Time frame: Baseline (Day 0 of reSURFACE Studies), Week 48 (Current study)
The BSA measures the total area of the body affected by psoriasis assessed by the study physician in terms of percentage. Baseline value of reSURFACE Studies was used to calculate change at Week 48 of current study. Baseline defined as the last value measured on Day 0 (Week 0) prior to the first tildrakizumab administration (also if participant participated in tildrakizumab [reSURFACE] clinical trials).
Cohort 1: Change From Baseline of reSURFACE Study in Percentage of Body Surface Area (BSA) Affected by Psoriasis at Week 96
Time frame: Baseline (Day 0 of reSURFACE Studies), Week 96 (Current Study)
The BSA measures the total area of the body affected by psoriasis assessed by the study physician in terms of percentage. Baseline value of reSURFACE Studies was used to calculate change at Week 96 of current study. Baseline defined as the last value measured on Day 0 (Week 0) prior to the first tildrakizumab administration (also if participant participated in tildrakizumab [reSURFACE] clinical trials).
Cohort 1: Absolute Physician's Global Assessment (PGA) (General, Nail, Scalp) Scores at Week 48
Time frame: At Week 48
The PGA is a 5-point measure of psoriasis. The PGA of psoriasis of the whole body (general), scalp and nail were made on a 5-point scale ranged from 0 to 4, where 0 = none (clear); 1 = minimal; 2 = mild; 3 = moderate; 4 = severe. The higher score indicates severe outcomes.
Cohort 1: Absolute Physician's Global Assessment (PGA) (General, Nail, Scalp) Scores at Week 96
Time frame: At Week 96
The PGA is a 5-point measure of psoriasis. The PGA of psoriasis of the whole body (general), scalp and nail were made on a 5-point scale ranged from 0 to 4, where 0 = none (clear); 1 = minimal; 2 = mild; 3 = moderate; 4 = severe. The higher score indicates severe outcomes.
Cohort 1: Change From Baseline (reSURFACE Studies for General and Current Study for Nail and Scalp) in Physician's Global Assessment (PGA) Score at Week 48
Time frame: Baseline (Day 0 of reSURFACE Studies for General and current study for Nail and Scalp), Week 48 (Current Study)
The PGA is a 5-point measure of psoriasis. The PGA of psoriasis of the whole body (general), scalp and nail were made on a 5-point scale ranged from 0 to 4, where 0 = none (clear); 1 = minimal; 2 = mild; 3 = moderate; 4 = severe. The higher score indicates severe outcomes. Baseline value of reSURFACE Studies was used to calculate change for "General" at Week 48 of current study. For "Nail" and "Scalp", Baseline value of current study was used to calculate change. Baseline defined as the last value measured on Day 0 (Week 0) prior to the first tildrakizumab administration (also if participant participated in tildrakizumab [reSURFACE] clinical trials).
Cohort 1: Change From Baseline (reSURFACE Studies for General and Current Study for Nail and Scalp) in Physician's Global Assessment (PGA) Score at Week 96
Time frame: Baseline (Day 0 of reSURFACE Studies for General and current study for Nail and Scalp), Week 96 (Current study)
The PGA is a 5-point measure of psoriasis. The PGA of psoriasis of the whole body (general), scalp and nail were made on a 5-point scale ranged from 0 to 4, where 0 = none (clear); 1 = minimal; 2 = mild; 3 = moderate; 4 = severe. The higher score indicates severe outcomes. Baseline value of reSURFACE Studies was used to calculate change for "General" at Week 96 of current study. For "Nail" and "Scalp", Baseline value of current study was used to calculate change. Baseline defined as the last value measured on Day 0 (Week 0) prior to the first tildrakizumab administration (also if participant participated in tildrakizumab [reSURFACE] clinical trials).
Cohort 2: Absolute Psoriasis Area and Severity Index (PASI) Score at Week 52
Time frame: At Week 52
The PASI was calculated by assessing four body regions: head (10% of skin), arms (20%), trunk (30%), and legs (40%). For each region, the area of skin affected was estimated and graded on a scale from 0 to 6, where 0 indicated no involved area and 6 indicated 90-100% of involved area. Within each area, the severity was estimated by 3 clinical signs: erythema (redness), induration (thickness) and desquamation (scaling). Severity parameters are measured on a scale of 0 to 4, from none to maximum. The sum of all 3 severity parameters was then calculated for each section of skin, multiplied by the area score for that area and multiplied by weight of respective sections (0.1 for head, 0.2 for arms, 0.3 for body and 0.4 for legs). The range of the PASI was from 0 (no psoriasis on the body) to 72 (the most severe case of psoriasis), where higher score indicates severe outcomes.
Cohort 2: Absolute Psoriasis Area and Severity Index (PASI) Scroe at Week 100
Time frame: At Week 100
The PASI was calculated by assessing four body regions: head (10% of skin), arms (20%), trunk (30%), and legs (40%). For each region, the area of skin affected was estimated and graded on a scale from 0 to 6, where 0 indicated no involved area and 6 indicated 90-100% of involved area. Within each area, the severity was estimated by 3 clinical signs: erythema (redness), induration (thickness) and desquamation (scaling). Severity parameters are measured on a scale of 0 to 4, from none to maximum. The sum of all 3 severity parameters was then calculated for each section of skin, multiplied by the area score for that area and multiplied by weight of respective sections (0.1 for head, 0.2 for arms, 0.3 for body and 0.4 for legs). The range of the PASI was from 0 (no psoriasis on the body) to 72 (the most severe case of psoriasis), where higher score indicates severe outcomes.
Cohort 2: Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 52
Time frame: Baseline (current study), Week 52
The PASI was calculated by assessing four body regions: head (10% of skin), arms (20%), trunk (30%), and legs (40%). For each region, the area of skin affected was estimated and graded on a scale from 0 to 6, where 0 indicated no involved area and 6 indicated 90-100% of involved area. Within each area, the severity was estimated by 3 clinical signs: erythema (redness), induration (thickness) and desquamation (scaling). Severity parameters are measured on a scale of 0 to 4, from none to maximum. The sum of all 3 severity parameters was then calculated for each section of skin, multiplied by the area score for that area and multiplied by weight of respective sections (0.1 for head, 0.2 for arms, 0.3 for body and 0.4 for legs). The range of the PASI was from 0 (no psoriasis on the body) to 72 (the most severe case of psoriasis), where higher score indicates severe outcomes. Baseline defined as the last value measured on Day 0 (Week 0) prior to the first tildrakizumab administration.
Cohort 2: Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 100
Time frame: Baseline (current study), Week 100
The PASI was calculated by assessing four body regions: head (10% of skin), arms (20%), trunk (30%), and legs (40%). For each region, the area of skin affected was estimated and graded on a scale from 0 to 6, where 0 indicated no involved area and 6 indicated 90-100% of involved area. Within each area, the severity was estimated by 3 clinical signs: erythema (redness), induration (thickness) and desquamation (scaling). Severity parameters are measured on a scale of 0 to 4, from none to maximum. The sum of all 3 severity parameters was then calculated for each section of skin, multiplied by the area score for that area and multiplied by weight of respective sections (0.1 for head, 0.2 for arms, 0.3 for body and 0.4 for legs). The range of the PASI was from 0 (no psoriasis on the body) to 72 (the most severe case of psoriasis), where higher score indicates severe outcomes. Baseline defined as the last value measured on Day 0 (Week 0) prior to the first tildrakizumab administration.
Cohort 2: Correlation Between Absolute Psoriasis Area and Severity Index (PASI) Scores and Dermatology Life Quality Index Adjusted for Not Relevant Responses (DLQI-R) at Week 52
Time frame: At Week 52
The PASI was calculated by assessing four body regions: head (10% of skin), arms (20%), trunk (30%), and legs (40%). The range of the PASI scale was from 0 (no psoriasis on the body) to 72 (the most severe case of psoriasis), where higher score indicates severe outcomes. The DLQI questionnaire consisted of 10 questions. Each question was scored from 0 to 3, giving a total score range from 0 (meaning no impact of skin disease on quality of life) to 30 (meaning maximum impact on quality of life), where higher score indicates severe impact on quality of life. The DLQI-R was a newly introduced variation of the regular DLQI that adjusted the total score for the number of not relevant responses and a valid scoring system for avoiding the bias of these not relevant responses of the questionnaire. Pearson correlation was performed for correlation analysis.
Cohort 2: Correlation Between Absolute Psoriasis Area and Severity Index (PASI) Scores and Dermatology Life Quality Index Adjusted for Not Relevant Responses (DLQI-R) at Week 100
Time frame: At Week 100
The PASI was calculated by assessing four body regions: head (10% of skin), arms (20%), trunk (30%), and legs (40%). The range of the PASI scale was from 0 (no psoriasis on the body) to 72 (the most severe case of psoriasis), where higher score indicates severe outcomes. The DLQI questionnaire consisted of 10 questions. Each question was scored from 0 to 3, giving a total score range from 0 (meaning no impact of skin disease on quality of life) to 30 (meaning maximum impact on quality of life), where higher score indicates severe impact on quality of life. The DLQI-R was a newly introduced variation of the regular DLQI that adjusted the total score for the number of not relevant responses and a valid scoring system for avoiding the bias of these not relevant responses of the questionnaire. Pearson correlation was performed for correlation analysis.
Cohort 2: Percentage of Participants Who Maintained Psoriasis Area and Severity Index (PASI) 75, 90, and 100 Responses at Week 52
Time frame: At Week 52
PASI 75 and 90 defined as percentage of participants who achieved >=75% and >=90% reductions, respectively in their PASI score from baseline. PASI 100 defined as percentage of participants who have achieved a complete resolution of all disease. PASI was calculated by assessing 4 body regions: head (10% of skin), arms (20%), trunk (30%), and legs (40%). For each region, area of skin affected was estimated and graded on a scale from 0 to 6, where 0 indicated no involved area and 6 indicated 90-100% of involved area. Within each area, severity was estimated by 3 clinical signs: erythema (redness), induration (thickness) and desquamation (scaling). Severity parameters measured on a scale of 0 to 4. Sum of all 3 severity parameters was then calculated for each section of skin, multiplied by area score for that area and multiplied by weight of respective sections (0.1 for head, 0.2 for arms, 0.3 for body and 0.4 for legs). PASI range was from 0 (no psoriasis) to 72 (most severe case).
Cohort 2: Percentage of Participants Who Maintained Psoriasis Area and Severity Index (PASI) 75, 90, and 100 Responses at Week 100
Time frame: At Week 100
PASI 75 and 90 defined as percentage of participants who achieved >=75% and >=90% reductions, respectively in their PASI score from baseline. PASI 100 defined as percentage of participants who achieved a complete resolution of all disease. PASI was calculated by assessing 4 body regions: head (10% of skin), arms (20%), trunk (30%), and legs (40%). For each region, area of skin affected was estimated and graded on a scale from 0 to 6, where 0 indicated no involved area and 6 indicated 90-100% of involved area. Within each area, severity was estimated by 3 clinical signs: erythema (redness), induration (thickness) and desquamation (scaling). Severity parameters measured on a scale of 0 to 4. Sum of all 3 severity parameters was then calculated for each section of skin, multiplied by area score for that area and multiplied by weight of respective sections (0.1 for head, 0.2 for arms, 0.3 for body and 0.4 for legs). PASI range was from 0 (no psoriasis) to 72 (most severe case).
Cohort 2: Percentage of Absolute Body Surface Area Affected by Psoriasis (BSA) at Week 52
Time frame: At Week 52
The BSA measures the total area of the body affected by psoriasis assessed by the study physician in terms of percentage.
Cohort 2: Percentage of Absolute Body Surface Area Affected by Psoriasis (BSA) at Week 100
Time frame: At Week 100
The BSA measures the total area of the body affected by psoriasis assessed by the study physician in terms of percentage.
Cohort 2: Change From Baseline in Percentage of Body Surface Area (BSA) Affected by Psoriasis at Week 52
Time frame: Baseline (current study), Week 52
The BSA measures the total area of the body affected by psoriasis assessed by the study physician in terms of percentage. Baseline defined as the last value measured on Day 0 (Week 0) prior to the first tildrakizumab administration.
Cohort 2: Change From Baseline in Percentage of Body Surface Area (BSA) Affected by Psoriasis at Week 100
Time frame: Baseline (current study), Week 100
The BSA measures the total area of the body affected by psoriasis assessed by the study physician in terms of percentage. Baseline defined as the last value measured on Day 0 (Week 0) prior to the first tildrakizumab administration.
Cohort 2: Absolute Physician's Global Assessment (PGA) (General, Nail and Scalp) Scores at Week 52
Time frame: At Week 52
The PGA is a 5-point measure of psoriasis. The PGA of psoriasis of the whole body (general), scalp and nail were made on a 5-point scale ranged from 0 to 4, where 0 = none (clear); 1 = minimal; 2 = mild; 3 = moderate; 4 = severe. The higher score indicates severe outcomes.
Cohort 2: Absolute Physician's Global Assessment (PGA) (General, Nail and Scalp) Scores at Week 100
Time frame: At Week 100
The PGA is a 5-point measure of psoriasis. The PGA of psoriasis of the whole body (general), scalp and nail were made on a 5-point scale ranged from 0 to 4, where 0 = none (clear); 1 = minimal; 2 = mild; 3 = moderate; 4 = severe. The higher score indicates severe outcomes.
Cohort 2: Change From Baseline in Physician's Global Assessment (PGA) (General, Nail and Scalp) Scores at Week 52
Time frame: Baseline (current study), Week 52
The PGA is a 5-point measure of psoriasis. The PGA of psoriasis of the whole body (general), scalp and nail were made on a 5-point scale ranged from 0 to 4, where 0 = none (clear); 1 = minimal; 2 = mild; 3 = moderate; 4 = severe. The higher score indicates severe outcomes. Baseline defined as the last value measured on Day 0 (Week 0) prior to the first tildrakizumab administration.
Cohort 2: Change From Baseline in Physician's Global Assessment (PGA) (General, Nail and Scalp) Scores at Week 100
Time frame: Baseline (current study), Week 100
The PGA is a 5-point measure of psoriasis. The PGA of psoriasis of the whole body (general), scalp and nail were made on a 5-point scale ranged from 0 to 4, where 0 = none (clear); 1 = minimal; 2 = mild; 3 = moderate; 4 = severe. The higher score indicates severe outcomes. Baseline defined as the last value measured on Day 0 (Week 0) prior to the first tildrakizumab administration.
23 secondary outcomes
Absolute Dermatology Life Quality Index (DLQI) Score at Week 48 and Week 96 for Cohort 1 and Week 52 and Week 100 for Cohort 2
Time frame: Cohort 1: Week 48 and Week 96; Cohort 2: Week 52 and Week 100
Change From Baseline in Absolute Dermatology Life Quality Index (DLQI) Score at Week 48 and Week 96 for Cohort 1 and Week 52 and Week 100 for Cohort 2
Time frame: Cohort 1: Baseline (current study), Week 48 and Week 96; Cohort 2: Baseline (current study), Week 52 and Week 100
Absolute Dermatology Life Quality Index Score Adjusted for Not Relevant Responses (DLQI-R) at Week 48 and Week 96 for Cohort 1 and Week 52 and Week 100 for Cohort 2
Time frame: Cohort 1: Week 48 and Week 96; Cohort 2: Week 52 and Week 100
Change From Baseline in Dermatology Life Quality Index Score Adjusted for Not Relevant Responses at Week 48 and Week 96 for Cohort 1 and Week 52 and Week 100 for Cohort 2
Time frame: Cohort 1: Baseline (current study), Week 48 and Week 96; Cohort 2: Baseline (current study), Week 52 and Week 100
Itch and Pain Visual Analogue Scales (VAS) Scores at Week 96 for Cohort 1 and Week 100 for Cohort 2
Time frame: Cohort 1: At Week 96; Cohort 2: At Week 100
Change From Baseline in Itch and Pain Visual Analogue Scales (VAS) Scores at Week 96 for Cohort 1 and Week 100 for Cohort 2
Time frame: Cohort 1: At Week 96; Cohort 2: At Week 100
Absolute Scores of Participant's Satisfaction With Tildrakizumab Therapy as Assessed by Treatment Satisfaction Questionnaire for Medication (TSQM) at Week 96 for Cohort 1 and Week 100 for Cohort 2
Time frame: Cohort 1: At Week 96; Cohort 2: At Week 100
Absolute Scores of Physician's Satisfaction With Tildrakizumab Therapy for Effectiveness and Tolerability at Week 96 for Cohort 1 and Week 100 for Cohort 2
Time frame: Cohort 1: At Week 96; Cohort 2: At Week 100
Number of Participants Who Added Concomitant Medications
Time frame: Cohort 1: Baseline (current study) up to Week 96; Cohort 2: Baseline (current study) up to Week 100
Change From Baseline in Body Weight up to Week 96 for Cohort 1 and Week 100 for Cohort 2
Time frame: Cohort 1: Baseline (current study) up to Week 96; Cohort 2: Baseline (current study) up to Week 100
Change From Baseline in Waist and Hip Circumference at Week 96 for Cohort 1 and Week 100 for Cohort 2
Time frame: Cohort 1: Baseline (current study), Week 96; Cohort 2: Baseline (current study), Week 100
Change From Baseline in Waist/Hip Ratio at Week 96 for Cohort 1 and Week 100 for Cohort 2
Time frame: Cohort 1: Baseline (current study), Week 96; Cohort 2: Baseline (current study), Week 100
Change From Baseline in Body Mass Index (BMI) at Week 96 for Cohort 1 and Week 100 for Cohort 2
Time frame: Cohort 1: Baseline (current study), Week 96; Cohort 2: Baseline (current study), Week 100
Change From Baseline in Systolic and Diastolic Blood Pressure (BP) at Week 96 for Cohort 1 and Week 100 for Cohort 2
Time frame: Cohort 1: Baseline (current study), Week 96; Cohort 1: Baseline (current study), Week 100
Number of Participants With Responses to Questions About Food Intake
Time frame: Cohort 1: Baseline (current study) up to Week 96; Cohort 2: Baseline (current study) up to Week 100
Number of Participants With Responses to Physical Activity Questionnaire
Time frame: Cohort 1: Baseline (current study) up to Week 96; Cohort 2: Baseline (current study) up to Week 100
Change From Baseline in Physical Activity at Week 96 for Cohort 1 and Week 100 for Cohort 2
Time frame: Cohort 1: Baseline (current study), Week 96; Cohort 2: Baseline (current study), Week 100
Change From Baseline in Lipid Profiles at Week 96 for Cohort 1 and Week 100 for Cohort 2
Time frame: Cohort 1: Baseline (current study), Week 96; Cohort 1: Baseline (current study), Week 100
Change From Baseline in Lipid Profile (Lipoprotein-a) at Week 96 for Cohort 1 and Week 100 for Cohort 2
Time frame: Cohort 1: Baseline (current study), Week 96; Cohort 1: Baseline (current study), Week 100
Number of Participants Withdrawn From the Study
Time frame: Cohort 1: Baseline (current study) up to Week 96; Cohort 2: Baseline (current study) up to Week 100
Number of Participants With Reason for Tildrakizumab Dosage Change
Time frame: Cohort 1: At Week 84; Cohort 2: At Week 100
Drug Survival
Time frame: Cohort 1: Baseline (current study) up to Week 96; Cohort 2: Baseline (current study) up to Week 100
Participants Adherence as Assessed by Time to Study Discontinuation
Time frame: Cohort 1: Baseline (current study) up to Week 96; Cohort 2: Baseline (current study) up to Week 100
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
Almirall, S.A.
41 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Plaque Psoriasis, run by Almirall, S.A. at 41 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 41 sites in Germany, Italy, Belgium, Austria, France and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cohort 1: Absolute Psoriasis Area and Severity Index (PASI) Score at Week 48 (time frame: At Week 48). The study lists 32 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2026.