Risankizumab Therapy Versus Placebo for Subjects With Psoriasis in the Russian Federation

Study Overview
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Brief Summary
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The purpose of this study is to assess the safety and efficacy of risankizumab compared to placebo in subjects with moderate to severe chronic plaque psoriasis in the Russian Federation.

Official Title
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Risankizumab Versus Placebo in a Randomized, Double Blind, Parallel Group Trial in Moderate to Severe Plaque Psoriasis to Assess Safety and Efficacy After 16 Weeks of Treatment in the Russian Federation (IMMpress)

Conditions
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Psoriasis

Intervention / Treatment
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* Drug: risankizumab
* Drug: placebo for rizankizumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A diagnosis of chronic plaque psoriasis (with or without psoriatic arthritis) for at least 6 months before the first administration of study drug. Moderate to severe chronic plaque psoriasis at both Screening and Baseline (Randomization) Visits Candidates for systemic therapy or phototherapy for psoriasis treatment as assessed by the investigator Exclusion Criteria: Prior therapy with an anti-interleukin (IL)-17 or anti-IL12/23p40 or anti-IL-23p19 inhibitor Concurrent therapy with a biologic and/or other systemic therapy

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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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo for risankizumab by subcutaneous (SC) injection. | Drug: placebo for rizankizumab<br>* placebo for rizankizumab subcutaneous (SC) infusion<br>|
| Experimental: Risankizumab<br>Risankizumab by subcutaneous (SC) injection. | Drug: risankizumab<br>* rizankizumab subcutaneous (SC) infusion<br>* Other names: BI 655066;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants with a 90% reduction from Baseline Psoriasis Area and Severity Index (PASI 90) at Week 16 | The PASI score is an established measure of clinical efficacy for psoriasis medications. | Week 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants with Static Physician Global Assessment (sPGA) score of clear or almost clear (0, 1) at Week 16 | The sPGA is based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions. | Week 16 | 
| Proportion of participants with a 75% reduction from Baseline Psoriasis Area and Severity Index (PASI 75) at Week 16 | The PASI score is an established measure of clinical efficacy for psoriasis medications. | Week 16 | 
| Proportion of participants with a 100% reduction from Baseline Psoriasis Area and Severity Index (PASI 100) at Week 16 | The PASI score is an established measure of clinical efficacy for psoriasis medications. | Week 16 | 
| Proportion of Participants Achieving a Dermatology Life Quality Index (DLQI) Score of 0 or 1 at Week 16 | The DLQI is a self-administered, ten-question questionnaire used to assess the effect of different skin diseases on a subject's quality of life, overall health, and disability status. Scores range from 0 (not relevant/not at all) to 3 (very much). | Week 16 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Plaque Psoriasis