Plaque PsoriasisNCT06488170
A Study to Assess Patient-Reported Wellbeing Using Tildrakizumab in a Live Setting
An observational study of Plaque Psoriasis, run by Almirall, S.A. at 7 sites in Czechia.
Trial summary
The main purpose of this study to investigate the relationship between clinical symptoms and quality of life (QoL) in participants who receive Tildrakizumab in the frame of clinical routine for the treatment of moderate to severe plaque psoriasis in accordance with the summary of product characteristics (SmPC). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Plaque Psoriasis
- What is being tested?
- Tildrakizumab
- How many people
- 42 participants
- Where
- 7 sitesCzechia
- Study dates
- 4 Apr 2024to Jan 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population consists of participants with diagnosis of moderate-to-severe plaque psoriasis in accordance with the SmPC.
Who may be able to join
- Participant with diagnosis of moderate or severe chronic plaque PSO documented in the medical chart.
- Participant who needs systemic biologic therapy and qualifies for treatment with an IL-23p19 inhibitor. Tildrakizumab must be the anti-Il-23p19 selected therapy before including the patient in the study.
- Participant aged greater than or equal to (>=) 18 years at Inclusion.
- Written informed consent.
Who cannot join
- Participant unable or unwilling to comply with the requirements of the study.
- Participant who should not participate in the study for any reason at the discretion of the treating physician.
- Participants participating in a simultaneous clinical trial.
- Any contraindication against the use of Tildrakizumab according to the SmPC.
- Exposure to >= 3 biologics prior to inclusion.
- Participant dependent on the investigator, e.g. as employee
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Czechia7 sites
University Hospital Ostrava
Ostrava, 708 52
Fakultní nemocnice Plzeň, with its registred seat at Edvarda Beneše
Pilsen, 301 00
University Hospital Kralovske Vinohrady
Prague, 100 00
University Hospital in Motol
Prague, 150 06
General university hospital Prague
Prague
University Hospital Bulovka
Prague
Masarykova hospital Ústí nad Labem
Ústí nad Labem
About this study
Official title: Patient-Reported Wellbeing Using Tildrakizumab in a Live Setting - Light Version
The main purpose of this study to investigate the relationship between clinical symptoms and quality of life (QoL) in participants who receive Tildrakizumab in the frame of clinical routine for the treatment of moderate to severe plaque psoriasis in accordance with the summary of product characteristics (SmPC).
- Conditions
- Plaque Psoriasis
- Being tested
- Tildrakizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TildrakizumabDrug
Also called IL-23p19 inhibitor
As provided in real world clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| Tildrakizumab | Participants who received Tildrakizumab in the frame of clinical routine for the treatment of moderate to severe plaque psoriasis in accordance with the SmPC will be observed for Week 28. Receives: Drug: Tildrakizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in 5-item World Health Organization Wellbeing Index (WHO-5) Score
The WHO-5 is a widely used self-reported questionnaire designed to measure subjective well-being. It assesses the individual's overall psychological well-being and quality of life. The WHO-5 consists of five simple questions that ask respondents to rate their well-being over the past two weeks. The questions cover aspects such as positive mood, vitality, and general interest in life. The questionnaire is scored on a scale from 0 to 100, with higher scores indicating better well-being.
Measured: Baseline to Week 28
Secondary outcomes (13)
Change From Baseline in Dermatology Life Quality Index (DLQI) Score
DLQI is a dermatology-specific instrument used to measure the impact of skin diseases on patients' quality of life. Which assessed disease impact, monitor treatment effectiveness, guide clinical decision-making. Interpretation of Scores: 0-1: No effect on patient's life 2-5: Small effect on patient's life 6-10: Moderate effect on patient's life 11-20: Very large effect on patient's life 21-30: Extremely large effect on patient's life.
Measured: Baseline, Week 16 and 28
Change from Baseline in Absolute Psoriasis Area and Severity Index (PASI) Score
The PASI is a measure of psoriasis and psoriatic arthritis severity that will be assessed at baseline and all follow-up visits for participants with psoriasis or psoriatic arthritis. This common clinical measure selects a representative area of psoriasis for each body region. The intensity of redness, thickness, and scaling of the psoriasis is assessed by the clinician. PASI scores range from 0 to 72, with higher scores indicating worse symptoms.
Measured: Baseline, Week 16 and 28
Change from Baseline in Relative PASI Score
The PASI is a measure of psoriasis and psoriatic arthritis severity that will be assessed at baseline and all follow-up visits for participants with psoriasis or psoriatic arthritis. This common clinical measure selects a representative area of psoriasis for each body region. The intensity of redness, thickness, and scaling of the psoriasis is assessed by the clinician. PASI scores range from 0 to 72, with higher scores indicating worse symptoms.
Measured: Baseline, Week 16 and 28
Change from Baseline in Patient´s Assessment of Itch, Pain and Joint Pain as Measured by Numerical Rating Scale (NRS)
NRS is the simplest and most commonly used scales to indicate the degree of pain, itch, and discomfort. The numerical scale is most commonly 0 to 10, with 0 being "no pain or Itch or discomfort" and 10 being "the worst imaginable pain or Itch or discomfort".
Measured: Baseline, Week 16 and 28
Number of Participants Achieving Scalp Specific Physician's Global Assessment (PGA) Score
Scalp PGA assesses the overall severity of active psoriasis on the participant's scalp. Scalp lesions will be evaluated in terms of clinical signs of erythema, induration, and scaling and scored on 5-point ssPGA scale where 0=absence of disease and 4=severe disease. Higher scores indicate worsening.
Measured: Baseline, Week 16 and 28
Number of Participants Achieving Nail Specific PGA Score
The nail specific PGA is used to evaluate the current status of a participant's nail psoriasis on a scale of 0 to 4 (clear [0], minimal [1], mild [2], moderate [3], or severe [4]).
Measured: Baseline, Week 16 and 28
Number of Participants Achieving Palmoplantar PGA Score
The PGA is a widely used outcome measure that relies on physician visual assessment of disease severity. The PGA determines psoriasis severity at a single point in time, without taking the baseline disease condition into clear (0), almost clear (1), mild (2), moderate (3), severe (4).
Measured: Baseline, Week 16 and 28
Number of Participants with Psoriasis (PSO) on Family and Partners by Family PSO Questionnaire
PSO is a self-administered questionnaire designed to address impact of PSO on family and partners by Family PSO questionnaire. Family PSO is a self-administrated questionnaire to assess the burden on partners of patients with psoriasis. The questionnaire has 15 items divided into five factors: (1) perceived strain by social reactions to the partner's psoriasis; (2) strain caused by cleaning; (3) acute emotional strain attributed directly to the psoriasis; (4) restrictions of social life; and (5) general emotional strain. The items are scaled in a 5-point Likert format: 0='not true', 1='somewhat true', 2='moderately true', 3='quite true', 4='very true', with the supplementary option 'does not apply to me'.
Measured: Baseline, Week 16 and 28
Number of Participants with Psoriasis Treatment on Physician's Satisfaction
Measured: Baseline, Week 28
Hospital Anxiety and Depression Scales (HADS) Questionnaire
The HADS is a self-report rating scale of 14 items on a 4-point Likert scale (range 0-3). It is designed to measure anxiety and depression (7 items for each subscale). The total score is the sum of the 14 items, and for each subscale the score is the sum of the respective seven items (ranging from 0-21). A score between 0 and 7 is 'normal', between 8 and 10 shows "light" level, between 11 and 14 "moderate" level, and between 15 and 21 "severe" level of anxiety/depression.
Measured: Baseline, Week 16 and 28
Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)
FACIT-F is a questionnaire-based tool (FACIT-F, Vision 4) used to measure fatigue in patients. It consists of multiple items, each focusing on a different aspect of fatigue. The items are typically rated on a scale from 0 to 4, with 0 representing "not at all" and 4 representing "very much". Example items include: "I feel tired" or "I'm too tired to working". Higher scores indicate less fatigue.
Measured: Baseline, Week 16 and 28
Correlations Between the Aforementioned Parameters, in Particular WHO-5 and HADS
To determine the correlation between the aforementioned parameters, in particular WHO-5 and HADS. Correlations between parameters are tested by the non-parametric Spearman test. In case of significant correlations, and if the nature of the data allows it, the conduct of more advanced regression analyses is permissible.
Measured: Baseline, Week 16 and 28
Correlations Between the Aforementioned Parameters, in Particular WHO-5 and FACIT-F
To determine the correlation between the aforementioned parameters, in particular WHO-5 and FACIT-F. Correlations between parameters are tested by the non-parametric Spearman test. In case of significant correlations, and if the nature of the data allows it, the conduct of more advanced regression analyses is permissible.
Measured: Baseline, Week 16 and 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2024
- Study start4 Apr 2024
- Primary completionJan 2026 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 42 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
- NCT06488170
- Sponsor's protocol ID
- POSITIVE LIGHT
- Status last verified
- Jun 2025
- First submitted
- 28 Jun 2024
- Last updated
- 24 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-Reported Wellbeing Using Tildrakizumab in a Live Setting - Light Version
- ClinicalTrials.gov ID
- NCT06488170
- Acronym / sponsor ID
- POSITIVE LIGHT
- Conditions
- Plaque Psoriasis
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Almirall, S.A.Industry (pharma, biotech, devices)
- Study start
- 4 Apr 2024 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 5 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this study to investigate the relationship between clinical symptoms and quality of life (QoL) in participants who receive Tildrakizumab in the frame of clinical routine for the treatment of moderate to severe plaque psoriasis in accordance with the summary of product characteristics (SmPC).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tildrakizumab | – | Drug: TildrakizumabParticipants who received Tildrakizumab in the frame of clinical routine for the treatment of moderate to severe plaque psoriasis in accordance with the SmPC will be observed for Week 28. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of participants with diagnosis of moderate-to-severe plaque psoriasis in accordance with the SmPC.
Key inclusion criteria (4 listed)
- Participant with diagnosis of moderate or severe chronic plaque PSO documented in the medical chart.
- Participant who needs systemic biologic therapy and qualifies for treatment with an IL-23p19 inhibitor. Tildrakizumab must be the anti-Il-23p19 selected therapy before including the patient in the study.
- Participant aged greater than or equal to (>=) 18 years at Inclusion.
- Written informed consent.
Key exclusion criteria (6 listed)
- Participant unable or unwilling to comply with the requirements of the study.
- Participant who should not participate in the study for any reason at the discretion of the treating physician.
- Participants participating in a simultaneous clinical trial.
- Any contraindication against the use of Tildrakizumab according to the SmPC.
- Exposure to >= 3 biologics prior to inclusion.
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: IL-23p19 inhibitorAs provided in real world clinical practice. | Drug | Tildrakizumab |
Primary outcome
Change From Baseline in 5-item World Health Organization Wellbeing Index (WHO-5) Score
Time frame: Baseline to Week 28
The WHO-5 is a widely used self-reported questionnaire designed to measure subjective well-being. It assesses the individual's overall psychological well-being and quality of life. The WHO-5 consists of five simple questions that ask respondents to rate their well-being over the past two weeks. The questions cover aspects such as positive mood, vitality, and general interest in life. The questionnaire is scored on a scale from 0 to 100, with higher scores indicating better well-being.
13 secondary outcomes
Change From Baseline in Dermatology Life Quality Index (DLQI) Score
Time frame: Baseline, Week 16 and 28
Change from Baseline in Absolute Psoriasis Area and Severity Index (PASI) Score
Time frame: Baseline, Week 16 and 28
Change from Baseline in Relative PASI Score
Time frame: Baseline, Week 16 and 28
Change from Baseline in Patient´s Assessment of Itch, Pain and Joint Pain as Measured by Numerical Rating Scale (NRS)
Time frame: Baseline, Week 16 and 28
Number of Participants Achieving Scalp Specific Physician's Global Assessment (PGA) Score
Time frame: Baseline, Week 16 and 28
Number of Participants Achieving Nail Specific PGA Score
Time frame: Baseline, Week 16 and 28
Number of Participants Achieving Palmoplantar PGA Score
Time frame: Baseline, Week 16 and 28
Number of Participants with Psoriasis (PSO) on Family and Partners by Family PSO Questionnaire
Time frame: Baseline, Week 16 and 28
Number of Participants with Psoriasis Treatment on Physician's Satisfaction
Time frame: Baseline, Week 28
Hospital Anxiety and Depression Scales (HADS) Questionnaire
Time frame: Baseline, Week 16 and 28
Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)
Time frame: Baseline, Week 16 and 28
Correlations Between the Aforementioned Parameters, in Particular WHO-5 and HADS
Time frame: Baseline, Week 16 and 28
Correlations Between the Aforementioned Parameters, in Particular WHO-5 and FACIT-F
Time frame: Baseline, Week 16 and 28
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2025.
- Individual participant dataSharing planned: No
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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.
7 sites in 1 country: 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 7 sites in Czechia.
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 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: under way, not looking for participants, as of the sponsor's last update on 24 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Czechia. 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?
This study is still under way. Results are not available in the source record yet.
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?
Change From Baseline in 5-item World Health Organization Wellbeing Index (WHO-5) Score (time frame: Baseline to Week 28). 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 24 Jun 2025.