PsoriasisPhase 2NCT01225731
A Study to Determine the Optimal Dose of Tildrakizumab (SCH 900222/MK-3222) for the Treatment of Moderate-to-severe Chronic Plaque Psoriasis (P05495) (MK-3222-003)
A Phase 2 study testing tildrakizumab in people with Psoriasis, run by Merck Sharp & Dohme LLC.
Trial summary
This is a response-driven study of tildrakuzumab for the treatment of moderate to severe chronic plaque psoriasis. The primary study hypothesis is that one or more doses of tildrakizumab will be superior to placebo for the treatment of psoriasis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis
- What is being tested?
- tildrakizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 355 participants
- Where
- No sites listed yet
- Study dates
- 25 Oct 2010to 24 Oct 2012
- Phase
- Phase 2
- 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
Who may be able to join
- Adult participants (≥18 years of age) with a diagnosis of moderate-to-severe chronic plaque psoriasis (defined by ≥10% body surface area [BSA] involvement, "moderate" or greater score on the Physician's Global Assessment [PGA] scale, and PASI score ≥12 at Baseline)
- Participants must have a diagnosis of predominantly plaque psoriasis for ≥6 months (as determined by interview and confirmation of diagnosis through physical examination by investigator) and be considered candidates for phototherapy or systemic therapy. Participants with psoriatic arthritis may be included in the study
Who cannot join
- Nonplaque forms of psoriasis specifically erythrodermic psoriasis, predominantly pustular psoriasis, medication-induced or medication-exacerbated psoriasis, or new onset guttate psoriasis
- Participants who will require oral or injectable corticosteroids during the trial
- Presence of any infection requiring treatment with systemic antibiotics within 2 weeks prior to Screening, or serious infection (eg, pneumonia, cellulitis, bone or joint infections) requiring hospitalization or treatment with intravenous antibiotics within 8 weeks prior to Screening
- Participants with evidence of active or untreated latent tuberculosis (TB) according to Screening criteria specified in the protocol. (Prophylactic treatment for latent TB as per local guidelines must be initiated at least 4 weeks prior to treatment with study medication)
- Previous exposure to any agents targeting interleukin-12 (IL-12) and/or Interleukin-23 (IL-23)
- Participants with prior exposure to two or more tumor necrosis factor (TNF) antagonists with discontinuation due to lack of efficacy.
About this study
Official title: Randomized, Double-Blinded, Placebo-Controlled, Parallel-Design, Dose-Range Finding Study of Subcutaneous Tildrakizumab (SCH 900222/MK-3222) in Subjects With Moderate-to-Severe Chronic Plaque Psoriasis (Study P05495)
This is a response-driven study of tildrakuzumab for the treatment of moderate to severe chronic plaque psoriasis. The primary study hypothesis is that one or more doses of tildrakizumab will be superior to placebo for the treatment of psoriasis.
Read the detailed description
Each participant will be enrolled in the trial for approximately 72-76 weeks. Each participant will receive assigned treatment at Weeks 0 and 4 in Part I. At Week 16, the dosage of treatment the patient is assigned to may be adjusted based on the Psoriasis Area and Severity Index (PASI) 75 response (responder vs non-responder). Participants will receive study medication once every 12 weeks during Part 2 (Weeks 16 to 52); no participants will receive placebo in Part 2. Part 3 is an observational period and each subject will continue to be monitored on a monthly basis through Week 72. Subjects will not receive any study medication during Part 3.
- Conditions
- Psoriasis
- Being tested
- tildrakizumab, Placebo
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tildrakizumabBiological
Also called SCH 900222, MK-3222
SC administration of tildrakizumab at assigned dose
PlaceboDrug
SC administration of Placebo
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Tildrakizumab 5 mg | Experimental | Participants receive tildrakizumab 5 mg, subcutaneously (SC) at Weeks 0 and 4 Receives: Biological: tildrakizumab |
| Part 1: Tildrakizumab 25 mg | Experimental | Participants receive tildrakizumab 25 mg, SC, at Weeks 0 and 4 Receives: Biological: tildrakizumab |
| Part 1: Tildrakizumab 100 mg | Experimental | Participants receive tildrakizumab 100 mg, SC, at Weeks 0 and 4 Receives: Biological: tildrakizumab |
| Part 1: Tildrakizumab 200 mg | Experimental | Participants receive tildrakizumab 200 mg, SC, at Weeks 0 and 4 Receives: Biological: tildrakizumab |
| Part 1: Placebo | Placebo comparator | Participants receive placebo, SC, at Weeks 0 and 4 Receives: Drug: Placebo |
| Part 2: Tildrakizumab 5 mg | Experimental | Participants receive tildrakizumab 5 mg, SC, every 12 weeks for up to 36 weeks Receives: Biological: tildrakizumab |
| Part 2: Tildrakizumab 25 mg | Experimental | Participants receive tildrakizumab 25 mg, SC, every 12 weeks for up to 36 weeks Receives: Biological: tildrakizumab |
| Part 2: Tildrakizumab 100 mg | Experimental | Participants receive tildrakizumab 100 mg, SC, every 12 weeks for up to 36 weeks Receives: Biological: tildrakizumab |
| Part 2: Tildrakizumab 200 mg | Experimental | Participants receive tildrakizumab 200 mg, SC, every 12 weeks for up to 36 weeks Receives: Biological: tildrakizumab |
| Part 3: Tildrakizumab 5 mg Follow-up | No intervention | Participants are followed for up to 20 weeks after the last dose of study drug. |
| Part 3: Tildrakizumab 25 mg Follow-up | No intervention | Participants are followed for up to 20 weeks after the last dose of study drug. |
| Part 3: Tildrakizumab 100 mg Follow-up | No intervention | Participants are followed for up to 20 weeks after the last dose of study drug. |
| Part 3: Tildrakizumab 200 mg Follow-up | No intervention | Participants are followed for up to 20 weeks after the last dose of study drug. |
| Part 3: Placebo Follow-up | No intervention | Participants are followed for up to 20 weeks after the last dose of study drug. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With a Psoriasis Area and Severity Index (PASI)75 Response at Week 16
The PASI score measures the severity and extent of psoriasis. Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness, and scaling of the largest psoriatic area in that region producing a Lesion Score. The percentage of the area affected by disease is then estimated, ranging from 0 = no lesions to 6 = 90-100% of the region is covered providing an Area Score. Then, the Lesion Score and Area Score for each region are multiplied, producing 4 subtotals. The 4 region subtotals are multiplied by a standardized percentage of body surface area for that region (head = 0.1, trunk = 0.3, arms=0.2, and legs = 0.4); these four region calculations are added to provide the final PASI score, ranging from 0 = no disease to 72 = maximal disease). PASI 75 response was defined as >=75% improvement in PASI score when compared to the baseline score.
Measured: Week 16
Number of Participants Experiencing Adverse Events
An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.
Measured: Up to 72 weeks
Number of Particpants Discontinuing Study Treatment Due to Adverse Events
An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment. Participants may be discontinued from study drug due to adverse events, but remain on the study.
Measured: Up to 52 weeks
Secondary outcomes (10)
Percentage of Participants With a PASI 75 Response at Week 12
The PASI score measures the severity and extent of psoriasis. Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness, and scaling of the largest psoriatic area in that region producing a Lesion Score. The percentage of the area affected by disease is then estimated, ranging from 0 = no lesions to 6 = 90-100% of the region is covered providing an Area Score. Then, the Lesion Score and Area Score for each region are multiplied, producing 4 subtotals. The 4 region subtotals are multiplied by a standardized percentage of body surface area for that region (head = 0.1, trunk = 0.3, arms=0.2, and legs = 0.4); these four region calculations are added to provide the final PASI score, ranging from 0 = no disease to 72 = maximal disease). PASI 75 response was defined as >=75% improvement in PASI score when compared to the baseline score.
Measured: Week 12
Percentage of Participants With Physician's Global Assessment (PGA) of "Cleared" or "Minimal" at Week 16
The PGA is used to determine the overall severity of a subject's psoriasis lesions at a given time point. Overall lesions will be graded for induration, erythema, and scaling on a scale from 0 to 5. The sum of the 3 scales will be divided by 3 to obtain the PGA score. PGA is assessed as: 0= Cleared, except for residual discoloration. 1= Minimal, majority of lesions have individual scores that average . 2 =Mild, majority of lesions have individual scores that average 2. 3= Modreate, majority of lesions have individual scores that average 3. 4= Marked, majority of lesions have individual scores that average 4. 5= Severe, majority of lesions have individual scores that average 5.
Measured: Week 16
Percentage of Participants With PASI 90 Response at Week 16
The PASI score measures the severity and extent of psoriasis. Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness, and scaling of the largest psoriatic area in that region producing a Lesion Score. The percentage of the area affected by disease is then estimated, ranging from 0 = no lesions to 6 = 90-100% of the region is covered providing an Area Score. Then, the Lesion Score and Area Score for each region are multiplied, producing 4 subtotals. The 4 region subtotals are multiplied by a standardized percentage of body surface area for that region (head = 0.1, trunk = 0.3, arms=0.2, and legs = 0.4); these four region calculations are added to provide the final PASI score, ranging from 0 = no disease to 72 = maximal disease). PASI 90 response was defined as >=90 % improvement in PASI score when compared to the baseline score.
Measured: Week 16
Percentage of Participants With PASI 100 Response at Week 16
The PASI score measures the severity and extent of psoriasis. Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness, and scaling of the largest psoriatic area in that region producing a Lesion Score. The percentage of the area affected by disease is then estimated, ranging from 0 = no lesions to 6 = 90-100% of the region is covered providing an Area Score. Then, the Lesion Score and Area Score for each region are multiplied, producing 4 subtotals. The 4 region subtotals are multiplied by a standardized percentage of body surface area for that region (head = 0.1, trunk = 0.3, arms=0.2, and legs = 0.4); these four region calculations are added to provide the final PASI score, ranging from 0 = no disease to 72 = maximal disease). PASI 100 response was defined as 100 % improvement in PASI score when compared to the baseline score.
Measured: Week 16
PASI 75 Response Rate by Time
The PASI score measures the severity and extent of psoriasis. Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness, and scaling of the largest psoriatic area in that region producing a Lesion Score. The percentage of the area affected by disease is then estimated, ranging from 0 = no lesions to 6 = 90-100% of the region is covered providing an Area Score. Then, the Lesion Score and Area Score for each region are multiplied, producing 4 subtotals. The 4 region subtotals are multiplied by a standardized percentage of body surface area for that region (head = 0.1, trunk = 0.3, arms=0.2, and legs = 0.4); these four region calculations are added to provide the final PASI score, ranging from 0 = no disease to 72 = maximal disease).PASI 75 response was defined as >=75% improvement in PASI score when compared to the baseline score at Week 2, 4, 6, 8, 12, or 16.
Measured: Up to 16 Weeks
Mean Change From Baseline in PASI Score at Weeks 12 and 16
The PASI score measures the severity and extent of psoriasis. Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness, and scaling of the largest psoriatic area in that region producing a Lesion Score. The percentage of the area affected by disease is then estimated, ranging from 0 = no lesions to 6 = 90-100% of the region is covered providing an Area Score. Then, the Lesion Score and Area Score for each region are multiplied, producing 4 subtotals. The 4 region subtotals are multiplied by a standardized percentage of body surface area for that region (head = 0.1, trunk = 0.3, arms=0.2, and legs = 0.4); these four region calculations are added to provide the final PASI score, ranging from 0 = no disease to 72 = maximal disease).
Measured: Baseline and Weeks 12 and 16
Percentage of Participants With PASI 50 Response at Week 16
The PASI score measures the severity and extent of psoriasis. Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness, and scaling of the largest psoriatic area in that region producing a Lesion Score. The percentage of the area affected by disease is then estimated, ranging from 0 = no lesions to 6 = 90-100% of the region is covered providing an Area Score. Then, the Lesion Score and Area Score for each region are multiplied, producing 4 subtotals. The 4 region subtotals are multiplied by a standardized percentage of body surface area for that region (head = 0.1, trunk = 0.3, arms=0.2, and legs = 0.4); these four region calculations are added to provide the final PASI score, ranging from 0 = no disease to 72 = maximal disease). PASI 50 response was defined as >=50 % improvement in PASI score when compared to the baseline score.
Measured: Week 16
Mean Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 16
The DLQI is a 10-item questionnaire that measures how much participant skin problems have affected their life. Responses range from 0=Not at all to 3=Very much. The DLQI is broken down into 6 subscales: Symptoms and feelings (range 0-6), Daily activities (range 0-6), Leisure (range 0-6), Work and school (range 0-3), Personal relationships (range 0-6), and Treatment (range 0-3). DLQI subscales were summed to yield the DLQI total score, which could range from 0 to 30. For both DLQI subscales and DLQI total score, a higher score indicated a greater negative impact on life.
Measured: Week 16
Percentage of Participants Achieving DLQI Score of 0 or 1 at Week 16
The DLQI is a 10-item questionnaire that measures how much participant skin problems have affected their life. Responses range from 0=Not at all to 3=Very much. The DLQI is broken down into 6 subscales: Symptoms and feelings (range 0-6), Daily activities (range 0-6), Leisure (range 0-6), Work and school (range 0-3), Personal relationships (range 0-6), and Treatment (range 0-3). DLQI subscales were summed to yield the DLQI total score, which could range from 0 to 30. For both DLQI subscales and DLQI total score, a higher score indicated a greater negative impact on life.
Measured: Week 16
Percentage of Participants Achieving a >=5 Point Reduction in DLQI at Week 16
The DLQI is a 10-item questionnaire that measures how much participant skin problems have affected their life. Responses range from 0=Not at all to 3=Very much. The DLQI is broken down into 6 subscales: Symptoms and feelings (range 0-6), Daily activities (range 0-6), Leisure (range 0-6), Work and school (range 0-3), Personal relationships (range 0-6), and Treatment (range 0-3). DLQI subscales were summed to yield the DLQI total score, which could range from 0 to 30. For both DLQI subscales and DLQI total score, a higher score indicated a greater negative impact on life.
Measured: Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2010 (estimated)
- Study start25 Oct 2010
- Primary completion4 Nov 2011
- Study completion24 Oct 2012
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.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 355 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01225731
- Sponsor's protocol ID
- P05495
- Other IDs
- 2009-017272-24, MK-3222-003, 2009
- Status last verified
- Jan 2019
- First submitted
- 7 Oct 2010
- Last updated
- 5 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Publications
Papp K, Thaci D, Reich K, Riedl E, Langley RG, Krueger JG, Gottlieb AB, Nakagawa H, Bowman EP, Mehta A, Li Q, Zhou Y, Shames R. Tildrakizumab (MK-3222), an anti-interleukin-23p19 monoclonal antibody, improves psoriasis in a phase IIb randomized placebo-controlled trial. Br J Dermatol. 2015 Oct;173(4):930-9. doi: 10.1111/bjd.13932. Epub 2015 Oct 15.
PubMed 26042589Kerbusch T, Li H, Wada R, Jauslin PM, Wenning L. Exposure-response characterisation of tildrakizumab in chronic plaque psoriasis: Pooled analysis of 3 randomised controlled trials. Br J Clin Pharmacol. 2020 Sep;86(9):1795-1806. doi: 10.1111/bcp.14280. Epub 2020 Mar 25.
PubMed 32162721Jauslin P, Kulkarni P, Li H, Vatakuti S, Hussain A, Wenning L, Kerbusch T. Population-Pharmacokinetic Modeling of Tildrakizumab (MK-3222), an Anti-Interleukin-23-p19 Monoclonal Antibody, in Healthy Volunteers and Subjects with Psoriasis. Clin Pharmacokinet. 2019 Aug;58(8):1059-1068. doi: 10.1007/s40262-019-00743-7.
PubMed 30915660
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blinded, Placebo-Controlled, Parallel-Design, Dose-Range Finding Study of Subcutaneous Tildrakizumab (SCH 900222/MK-3222) in Subjects With Moderate-to-Severe Chronic Plaque Psoriasis (Study P05495)
- ClinicalTrials.gov ID
- NCT01225731
- Acronym / sponsor ID
- P05495
- Conditions
- Psoriasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 355 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 25 Oct 2010 (actual)
- Primary completion
- 4 Nov 2011 (actual)
- Study completion
- 24 Oct 2012 (actual)
- First posted
- 21 Oct 2010 (estimated)
- Results
- Posted 30 Mar 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a response-driven study of tildrakuzumab for the treatment of moderate to severe chronic plaque psoriasis. The primary study hypothesis is that one or more doses of tildrakizumab will be superior to placebo for the treatment of psoriasis.
Detailed description
Each participant will be enrolled in the trial for approximately 72-76 weeks. Each participant will receive assigned treatment at Weeks 0 and 4 in Part I. At Week 16, the dosage of treatment the patient is assigned to may be adjusted based on the Psoriasis Area and Severity Index (PASI) 75 response (responder vs non-responder). Participants will receive study medication once every 12 weeks during Part 2 (Weeks 16 to 52); no participants will receive placebo in Part 2. Part 3 is an observational period and each subject will continue to be monitored on a monthly basis through Week 72. Subjects will not receive any study medication during Part 3.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 14
| Arm | Type | Receives |
|---|---|---|
| Part 1: Tildrakizumab 5 mg | Experimental | Biological: tildrakizumabParticipants receive tildrakizumab 5 mg, subcutaneously (SC) at Weeks 0 and 4 |
| Part 1: Tildrakizumab 25 mg | Experimental | Biological: tildrakizumabParticipants receive tildrakizumab 25 mg, SC, at Weeks 0 and 4 |
| Part 1: Tildrakizumab 100 mg | Experimental | Biological: tildrakizumabParticipants receive tildrakizumab 100 mg, SC, at Weeks 0 and 4 |
| Part 1: Tildrakizumab 200 mg | Experimental | Biological: tildrakizumabParticipants receive tildrakizumab 200 mg, SC, at Weeks 0 and 4 |
| Part 1: Placebo | Placebo comparator | Drug: PlaceboParticipants receive placebo, SC, at Weeks 0 and 4 |
| Part 2: Tildrakizumab 5 mg | Experimental | Biological: tildrakizumabParticipants receive tildrakizumab 5 mg, SC, every 12 weeks for up to 36 weeks |
| Part 2: Tildrakizumab 25 mg | Experimental | Biological: tildrakizumabParticipants receive tildrakizumab 25 mg, SC, every 12 weeks for up to 36 weeks |
| Part 2: Tildrakizumab 100 mg | Experimental | Biological: tildrakizumabParticipants receive tildrakizumab 100 mg, SC, every 12 weeks for up to 36 weeks |
| Part 2: Tildrakizumab 200 mg | Experimental | Biological: tildrakizumabParticipants receive tildrakizumab 200 mg, SC, every 12 weeks for up to 36 weeks |
| Part 3: Tildrakizumab 5 mg Follow-up | No intervention | –Participants are followed for up to 20 weeks after the last dose of study drug. |
| Part 3: Tildrakizumab 25 mg Follow-up | No intervention | –Participants are followed for up to 20 weeks after the last dose of study drug. |
| Part 3: Tildrakizumab 100 mg Follow-up | No intervention | –Participants are followed for up to 20 weeks after the last dose of study drug. |
| Part 3: Tildrakizumab 200 mg Follow-up | No intervention | –Participants are followed for up to 20 weeks after the last dose of study drug. |
| Part 3: Placebo Follow-up | No intervention | –Participants are followed for up to 20 weeks after the last dose of study drug. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult participants (≥18 years of age) with a diagnosis of moderate-to-severe chronic plaque psoriasis (defined by ≥10% body surface area [BSA] involvement, "moderate" or greater score on the Physician's Global Assessment [PGA] scale, and PASI score ≥12 at Baseline)
- Participants must have a diagnosis of predominantly plaque psoriasis for ≥6 months (as determined by interview and confirmation of diagnosis through physical examination by investigator) and be considered candidates for phototherapy or systemic therapy. Participants with psoriatic arthritis may be included in the study
Key exclusion criteria (6 listed)
- Nonplaque forms of psoriasis specifically erythrodermic psoriasis, predominantly pustular psoriasis, medication-induced or medication-exacerbated psoriasis, or new onset guttate psoriasis
- Participants who will require oral or injectable corticosteroids during the trial
- Presence of any infection requiring treatment with systemic antibiotics within 2 weeks prior to Screening, or serious infection (eg, pneumonia, cellulitis, bone or joint infections) requiring hospitalization or treatment with intravenous antibiotics within 8 weeks prior to Screening
- Participants with evidence of active or untreated latent tuberculosis (TB) according to Screening criteria specified in the protocol. (Prophylactic treatment for latent TB as per local guidelines must be initiated at least 4 weeks prior to treatment with study medication)
- Previous exposure to any agents targeting interleukin-12 (IL-12) and/or Interleukin-23 (IL-23)
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 |
|---|---|---|
| tildrakizumabAlso: SCH 900222, MK-3222SC administration of tildrakizumab at assigned dose | Biological | Part 1: Tildrakizumab 100 mg, Part 1: Tildrakizumab 200 mg, Part 1: Tildrakizumab 25 mg, Part 1: Tildrakizumab 5 mg, Part 2: Tildrakizumab 100 mg, Part 2: Tildrakizumab 200 mg, Part 2: Tildrakizumab 25 mg, Part 2: Tildrakizumab 5 mg |
| PlaceboSC administration of Placebo | Drug | Part 1: Placebo |
Primary outcome
Percentage of Participants With a Psoriasis Area and Severity Index (PASI)75 Response at Week 16
Time frame: Week 16
The PASI score measures the severity and extent of psoriasis. Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness, and scaling of the largest psoriatic area in that region producing a Lesion Score. The percentage of the area affected by disease is then estimated, ranging from 0 = no lesions to 6 = 90-100% of the region is covered providing an Area Score. Then, the Lesion Score and Area Score for each region are multiplied, producing 4 subtotals. The 4 region subtotals are multiplied by a standardized percentage of body surface area for that region (head = 0.1, trunk = 0.3, arms=0.2, and legs = 0.4); these four region calculations are added to provide the final PASI score, ranging from 0 = no disease to 72 = maximal disease). PASI 75 response was defined as >=75% improvement in PASI score when compared to the baseline score.
Number of Participants Experiencing Adverse Events
Time frame: Up to 72 weeks
An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.
Number of Particpants Discontinuing Study Treatment Due to Adverse Events
Time frame: Up to 52 weeks
An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment. Participants may be discontinued from study drug due to adverse events, but remain on the study.
10 secondary outcomes
Percentage of Participants With a PASI 75 Response at Week 12
Time frame: Week 12
Percentage of Participants With Physician's Global Assessment (PGA) of "Cleared" or "Minimal" at Week 16
Time frame: Week 16
Percentage of Participants With PASI 90 Response at Week 16
Time frame: Week 16
Percentage of Participants With PASI 100 Response at Week 16
Time frame: Week 16
PASI 75 Response Rate by Time
Time frame: Up to 16 Weeks
Mean Change From Baseline in PASI Score at Weeks 12 and 16
Time frame: Baseline and Weeks 12 and 16
Percentage of Participants With PASI 50 Response at Week 16
Time frame: Week 16
Mean Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 16
Time frame: Week 16
Percentage of Participants Achieving DLQI Score of 0 or 1 at Week 16
Time frame: Week 16
Percentage of Participants Achieving a >=5 Point Reduction in DLQI at Week 16
Time frame: Week 16
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 26042589Papp K, Thaci D, Reich K, Riedl E, Langley RG, Krueger JG, Gottlieb AB, Nakagawa H, Bowman EP, Mehta A, Li Q, Zhou Y, Shames R. Tildrakizumab (MK-3222), an anti-interleukin-23p19 monoclonal antibody, improves psoriasis in a phase IIb randomized placebo-controlled trial. Br J Dermatol. 2015 Oct;173(4):930-9. doi: 10.1111/bjd.13932. Epub 2015 Oct 15.
- Derived from this study: PubMed 32162721Kerbusch T, Li H, Wada R, Jauslin PM, Wenning L. Exposure-response characterisation of tildrakizumab in chronic plaque psoriasis: Pooled analysis of 3 randomised controlled trials. Br J Clin Pharmacol. 2020 Sep;86(9):1795-1806. doi: 10.1111/bcp.14280. Epub 2020 Mar 25.
- Derived from this study: PubMed 30915660Jauslin P, Kulkarni P, Li H, Vatakuti S, Hussain A, Wenning L, Kerbusch T. Population-Pharmacokinetic Modeling of Tildrakizumab (MK-3222), an Anti-Interleukin-23-p19 Monoclonal Antibody, in Healthy Volunteers and Subjects with Psoriasis. Clin Pharmacokinet. 2019 Aug;58(8):1059-1068. doi: 10.1007/s40262-019-00743-7.
- Individual participant dataSharing planned: Yes. http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
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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.
Medical Director study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing tildrakizumab in people with Psoriasis, run by Merck Sharp & Dohme LLC.
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 2 inclusion and 6 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 5 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Mar 2015). 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?
Percentage of Participants With a Psoriasis Area and Severity Index (PASI)75 Response at Week 16 (time frame: Week 16). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01225731, which also lists 3 linked publications.
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 5 Feb 2019.