An Observational Study to Validate the Cumulative Life Course Impairment (CLCI) Instrument (DermCLCI-p) in Adult Participants With Moderate to Severe Chronic Plaque Psoriasis (PsO)

Study Overview
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Brief Summary
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The IMMagine study aims to validate the newly developed CLCI instrument (DermCLCI-p) in moderate to severe psoriasis (PsO) patients, who will be started on Risankizumb (RZB) treatment and will be enrolled into the validation study up to 28 weeks. The treatment decision for RZB must be made independent of this study enrollment.

Official Title
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Multi-Country Prospective Real-World Study to Validate the CLCI Instrument (DermCLCI-p) in Patients With Moderate-to-Severe Chronic Plaque Psoriasis (IMMagine)

Conditions
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Psoriasis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Confirmed diagnosis of moderate to severe chronic plaque-type psoriasis diagnosed by a dermatologist and presence of moderate to severe psoriasis symptoms according to physician's clinical judgment at the time of recruitment. Participants initiating RZB treatment for psoriasis as per local label. Physician's decision for treatment with risankizumab must have been reached prior to and independently of recruitment in the study. Participants able to understand and communicate with the investigator and comply with the requirements of the study. Willingness and ability to comply with all study requirements. Exclusion Criteria: - Current or recent (within the last 30 days) participation in an interventional clinical trial.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Risankizumab<br>Participants will receive risankizumab as prescribed by their physician according to local label. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validity of the Cumulative Life Course Impairment Instrument (DermCLCI-p) | The DermCLCI-p Questionnaire assesses the cumulative impairments in skin diseases. The DermCLCI instrument consists of 30 items and asks participants to consider their disease burden within the last two weeks. Items 1 to 28 are answered on a 4-point Likert scale ranging from 0 (not at all) to 3 (very). Items 29 and 30 are answered on a 5-point Likert scale ranging from 0 (not at all) to 4 (very). | Baseline through Week 28 | 
| Reliability of the Cumulative Life Course Impairment Instrument (DermCLCI-p) | The DermCLCI-p Questionnaire assesses the cumulative impairments in skin diseases. The DermCLCI instrument consists of 30 items and asks participants to consider their disease burden within the last two weeks. Items 1 to 28 are answered on a 4-point Likert scale ranging from 0 (not at all) to 3 (very). Items 29 and 30 are answered on a 5-point Likert scale ranging from 0 (not at all) to 4 (very). | Baseline through Week 28 | 
| Responsiveness of the Cumulative Life Course Impairment Instrument (DermCLCI-p) | The DermCLCI-p Questionnaire assesses the cumulative impairments in skin diseases. The DermCLCI instrument consists of 30 items and asks participants to consider their disease burden within the last two weeks. Items 1 to 28 are answered on a 4-point Likert scale ranging from 0 (not at all) to 3 (very). Items 29 and 30 are answered on a 5-point Likert scale ranging from 0 (not at all) to 4 (very). | Baseline through Week 28 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Plaque Psoriasis, PsO, Psoriasis, Risankizumab, RZB