Study of Subcutaneous Risankizumab Injection Compared to Oral Apremilast Tablets to Assess Change in Disease Activity And Adverse Events in Adult Participants With Moderate Plaque Psoriasis Who Are Candidates for Systemic Therapy

Study Overview
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Brief Summary
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Psoriasis (PsO) is a chronic disease characterized by marked inflammation of the skin that results in thick, red, scaly plaques. This study will assess how safe and effective risankizumab is compared to apremilast in adult participants with moderate plaque psoriasis. Adverse events and change in disease symptoms will be monitored. Risankizumab (Skyrizi) and apremilast are approved drugs for the treatment of moderate to severe PsO. Approximately 330 participants with moderate plaque psoriasis (PsO) will be enrolled across approximately 55 sites globally. The study has 2 periods : Period A from Baseline to Week 16, and Period B, from Week 16 to Week 52. In Period A, participants will be randomly placed into 2 groups to receive either subcutaneous risankizumab or oral apremilast for 16 weeks. In Period B, participants who received apremilast in Period A will again be randomly assigned to 1 of the 2 groups to receive either risankizumab or apremilast for 36 weeks. At weeks 28 and 40, participants considered non-responders to apremilast based on their psoriasis score will be offered to receive risankizumab. There may be a higher burden for participants in this study compared to usual standard of care. Participants will attend regular visits per routine clinical practice. The effect of the treatment will be checked by medical assessments, checking for side effects, and questionnaires.

Official Title
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A Phase 4 Multicenter, Randomized, Open-label, Efficacy Assessor-blinded Study of Risankizumab Compared to Apremilast for the Treatment of Adult Subjects With Moderate Plaque Psoriasis Who Are Candidates for Systemic Therapy

Conditions
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Psoriasis

Intervention / Treatment
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* Drug: Risankizumab
* Drug: Apremilast


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Candidates for systemic therapy with moderate chronic plaque psoriasis (PsO) (with or without psoriatic arthritis) at Screening and Baseline for at least 6 months prior to Baseline defined as: Body Surface Area (BSA) >= 10% and <= 15%; and Psoriasis Area and Severity Index (PASI) >= 12; and Static Physician Global Assessment (sPGA) = 3 (moderate) based on a 5-point scale (0 to 4). Exclusion Criteria: Participant has any form of PsO other than chronic plaque PsO (e.g., pustular PsO, palmoplantar pustulosis, acrodermatitis of Hallopeau, erythrodermic, or guttate PsO). History of current drug-induced PsO or a drug-induced exacerbation of pre-existing psoriasis. History of active ongoing inflammatory skin diseases other than PsO and psoriatic arthritis that could interfere with the assessment of PsO (e.g., hyperkeratotic eczema). Prior exposure to risankizumab or apremilast.

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1: Risankizumab<br>Participants will receive risankizumab Dose A in Period A and Period B. | Drug: Risankizumab<br>* Subcutaneous injection<br>* Other names: Skyrizi;|
| Experimental: Arm 2a: Apremilast/Risankizumab<br>Participants will receive apremilast Dose A in Period A followed by risankizumab Dose A in Period B. | Drug: Risankizumab<br>* Subcutaneous injection<br>* Other names: Skyrizi;Drug: Apremilast<br>* Oral Tablets<br>* Other names: Otezla;|
| Active Comparator: Arm 2b: Apremilast<br>Participants will receive apremilast Dose A in Period A and Period B. Non-responders at Week 28 and Week 40 will be offered to receive risankizumab Dose A. | Drug: Risankizumab<br>* Subcutaneous injection<br>* Other names: Skyrizi;Drug: Apremilast<br>* Oral Tablets<br>* Other names: Otezla;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 90 (Defined as at Least 90% Improvement in PASI From Baseline) in Intent to Treat Population in Period A (ITT_A) | The PASI is used to evaluate a participant's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, infiltration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72. | Week 16 | 
| Percentage of Participants Achieving Static Physician Global Assessment (sPGA) 0 or 1 With at least 2-grade Improvement From Baseline in Intent to Treat Population in Period A (ITT_A) | The sPGA is the physician's current assessment of the average thickness, erythema, and scaling of all psoriatic lesions. Scores range from 0 (clear) to 4 (severe). | Week 16 | 
| Percentage of Participants Achieving PASI 90 in Intent to Treat Population for Period B Non-Responders (ITT_B_NR) | The PASI is used to evaluate a participant's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, infiltration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72. | Week 52 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Achieving PASI 75 (Defined as at Least 75% Improvement in PASI From Baseline) in Intent to Treat Population in Period A (ITT_A) | The PASI is used to evaluate a participant's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, infiltration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72. | Week 16 | 
| Percentage of Participants Achieving PASI 75 in Intent to Treat Population for Period B Non-Responders (ITT_B_NR) | The PASI is used to evaluate a participant's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, infiltration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72. | Week 52 | 
| Percentage of Participants Achieving Static Physician Global Assessment (sPGA) 0 or 1 With at least 2-grade Improvement From Baseline in Intent to Treat Population for Period B Non-Responders (ITT_B_NR) | The sPGA is the physician's current assessment of the average thickness, erythema, and scaling of all psoriatic lesions. Scores range from 0 (clear) to 4 (severe). | Week 52 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Psoriasis, Plaque Psoriasis, Risankizumab, ABBV-066, Skyrizi, Apremilast