Study Description
Brief Summary
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.
Condition or Disease
Psoriasis
Study Design
| Study Type: | Interventional (Clinical Trial) |
| Actual Enrollment: | 351 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 3b 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 |
| Actual Study Start Date: | June 9, 2021 |
| Estimated Primary Completion Date: | April 2, 2023 |
| Estimated Study Completion Date: | April 2, 2023 |
Outcome Measures
Primary Outcome Measures
- 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) [ Time Frame: Week 16 ]
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.
- 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) [ Time Frame: Week 16 ]
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).
- Percentage of Participants Achieving PASI 90 in Intent to Treat Population for Period B Non-Responders (ITT_B_NR) [ Time Frame: Week 52 ]
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.
Secondary Outcome Measures
- 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) [ Time Frame: Week 16 ]
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.
- Percentage of Participants Achieving PASI 75 in Intent to Treat Population for Period B Non-Responders (ITT_B_NR) [ Time Frame: Week 52 ]
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.
- 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) [ Time Frame: Week 52 ]
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).
Eligibility Criteria
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.