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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
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Total Skin and Beauty Dermatology Center /ID# 233793
Birmingham, Alabama, United States
Advanced Research Associates - Glendale /ID# 229266
Glendale, Arizona, United States
Alliance Dermatology and MOHs Center, PC /ID# 229224
Phoenix, Arizona, United States
UC Davis Health /ID# 229133
Sacramento, California, United States
Florida Academic Centers Research and Education /ID# 229235
Coral Gables, Florida, United States
Olympian Clinical Research - Largo /ID# 233792
Largo, Florida, United States
Renstar Medical Research /ID# 228946
Ocala, Florida, United States
ForCare Clinical Research /ID# 229135
Tampa, Florida, United States
Arlington Dermatology /ID# 228945
Rolling Meadows, Illinois, United States
Dawes Fretzin, LLC /ID# 229010
Indianapolis, Indiana, United States
Start Date
June 9, 2021
Primary Completion Date
April 20, 2023
Completion Date
April 20, 2023
Last Updated
April 30, 2024
352
ACTUAL participants
Risankizumab
DRUG
Apremilast
DRUG
Lead Sponsor
AbbVie
NCT07449234
NCT07116967
NCT07250802
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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