Status:
COMPLETED
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
Lead Sponsor:
AbbVie
Conditions:
Psoriasis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 ...
Eligibility Criteria
Inclusion
- \- 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
- 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.
Key Trial Info
Start Date :
June 9 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 20 2023
Estimated Enrollment :
352 Patients enrolled
Trial Details
Trial ID
NCT04908475
Start Date
June 9 2021
End Date
April 20 2023
Last Update
April 30 2024
Active Locations (54)
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1
Total Skin and Beauty Dermatology Center /ID# 233793
Birmingham, Alabama, United States, 35205
2
Advanced Research Associates - Glendale /ID# 229266
Glendale, Arizona, United States, 85308
3
Alliance Dermatology and MOHs Center, PC /ID# 229224
Phoenix, Arizona, United States, 85032
4
UC Davis Health /ID# 229133
Sacramento, California, United States, 95816-3300