A Study Comparing the Safety and Efficacy of Risankizumab to Methotrexate in Subjects With Moderate to Severe Plaque Psoriasis

Study Overview
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Brief Summary
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The purpose of this study is to compare the safety and efficacy of risankizumab to methotrexate in participants with moderate to severe plaque psoriasis.

Official Title
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A Multicenter, Randomized, Double-Blind, Double-Dummy, Active Controlled Study Comparing the Safety and Efficacy of Risankizumab to Methotrexate in Subjects With Moderate to Severe Plaque Psoriasis

Conditions
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Psoriasis

Intervention / Treatment
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* Drug: risankizumab
* Drug: methotrexate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have a diagnosis of plaque psoriasis (with or without concurrent psoriatic arthritis) for at least 6 months before the first administration of study drug Have stable moderate to severe plaque psoriasis with or without psoriatic arthritis at both Screening and Baseline Visits Be a candidate for systemic therapy for plaque psoriasis as assessed by the investigator Be a candidate for treatment with methotrexate (MTX) according to local label Exclusion Criteria: Subjects with non-plaque forms of psoriasis, current drug-induced psoriasis, or active ongoing inflammatory diseases other than psoriasis that might confound study evaluations according to investigator's judgment Previous exposure to risankizumab Previous exposure to MTX Use of any prohibited medication or any drug considered likely to interfere with the safe conduct of the study, as assessed by the investigator Subject has a history of clinically significant hematologic, renal, or liver disease

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Methotrexate<br>Participants to receive double-blind methotrexate. | Drug: methotrexate<br>* capsule<br>|
| Experimental: Risankizumab<br>Participants to receive double-blind risankizumab. | Drug: risankizumab<br>* subcutaneous (SC) injection<br>* Other names: BI 655066;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants with Static Physician Global Assessment (sPGA) score of clear or almost clear (0, 1) at Week 28. | The sPGA is the physician's current assessment of the average thickness, erythema, and scaling of all psoriatic lesions. | Week 28 | 
| Percentage of participants with a ≥ 90% reduction from Baseline Psoriasis Area and Severity Index (PASI 90) at Week 28 | PASI90 denotes greater than or equal to 90% improvement in PASI score. PASI provides a quantitative assessment of psoriasis disease state based on the amount of body surface area that is affected and the degree of severity of erythema, induration, and scale, weighted by body part. | Week 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants with a 100% reduction from Baseline PASI score (PASI 100) at Week 28 | PASI100 denotes greater than or equal to 100% improvement in PASI score. PASI provides a quantitative assessment of psoriasis disease state based on the amount of body surface area that is affected and the degree of severity of erythema, induration, and scale, weighted by body part. | Week 28 | 
| Percentage of participants with a ≥ 75% reduction from Baseline PASI score (PASI 75) at Week 28 | PASI75 denotes greater than or equal to 75% improvement in PASI score. PASI provides a quantitative assessment of psoriasis disease state based on the amount of body surface area that is affected and the degree of severity of erythema, induration, and scale, weighted by body part. | Week 28 | 
| Percentage of participants with Static Physician Global Assessment (sPGA) score of clear (0) at Week 28 | The sPGA is the physician's current assessment of the average thickness, erythema, and scaling of all psoriatic lesions. | Week 28 | 
| Change from baseline in EQ-5D-5L at all visits collected | The EQ-5D-5L is a standardized non-disease specific instrument for describing and valuing health-related quality of life. | Week 28 | 
| Achievement of an increase of 0.1 or more points from baseline in European Quality of Life 5 Dimensions (EQ-5D-5L) at all visits | The EQ-5D-5L has five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. These dimensions are measured on a five-level scale: no problems, slight problems, moderate problems, severe problems, and extreme problems. | Week 28 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ABBV-066, BI 655066