Risankizumab Compared to Deucravacitinib for the Treatment of Adults with Moderate Plaque Psoriasis
Research type
Research Study
Full title
A Phase 4 Multicenter, Randomized, Open-label, Efficacy Assessor-blinded Study of Risankizumab Compared to Deucravacitinib for the Treatment of Adult Subjects with Moderate Plaque Psoriasis who are Candidates for Systemic Therapy.
IRAS ID
1009592
Contact name
Richard Waren
Contact email
Sponsor organisation
AbbVie Deutschland GmbH & Co.KG
Eudract number
2022-502050-14
Research summary
Psoriasis is a long-term skin disease which causes red, itchy, scaly patches most commonly on the knees, elbows, scalp, and torso (chest, back, and abdomen). In participants with psoriasis, certain skin cells multiply much faster and the skin can develop rough patches that may be red or white with scales. There are many types of psoriasis, but plaque psoriasis is the most common. The exact cause of psoriasis is unknown, but researchers think it may be caused by the body’s immune system not working properly.
This study is designed to enroll 336 participants 18 years of age and older with have been diagnosed with moderate chronic plaque psoriasis for at least 6 months prior to Baseline (Day 1) and who have not previously been treated with a biologic treatment (natural substance that is made by using living cells in a laboratory). This is a Phase 4, randomized, open-label, assessor blinded, active comparator study with 2 Parts. Phase 4 studies test treatments that have already been approved to treat patients with a condition or disease. This study is open-label,
which means that both participants and study doctors know which study treatment is given to participants. Participants will be administered subcutaneous (SC) treatment of risankizumab every 12 weeks for up to 44 weeks or provided deucravacitinib oral tablets to be taken once daily.REC name
North of Scotland Research Ethics Committee 1
REC reference
24/NS/0050
Date of REC Opinion
16 May 2024
REC opinion
Further Information Favourable Opinion