A Study to Learn How Safe and Effective Risankizumab is When Compared to Deucravacitinib to Treat Participants With Moderate Plaque Psoriasis and Who Need to Try Systemic Treatment (Works Throughout the Whole Body)

Study Identifier
M24-541
CT.gov Identifier
EudraCT Identifier
Not available
EUCTIS ID
2023-509738-20-00
For general inquiries, please contact
Study Complete

Study Details

Medical Condition
  • Dermatology - Psoriasis (PsO)
  • Study Drug
  • Risankizumab
  • Deucravacitinib
  • Phase
    Phase 4
    Sex
    Female & Male
    Age
    18+ years

    Protocol 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.

    There may be higher treatment burden for participants in this trial compared to their standard of care (due to study procedures). Participants will attend regular (weekly, monthly) visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

    Study Locations

    Location
    Status
    Location
    Total Skin and Beauty Dermatology Center /ID# 263011
    Birmingham, Alabama, United States, 35205
    Status
    Not applicable
    Location
    Advanced Research Associates - Glendale /ID# 263621
    Glendale, Arizona, United States, 85308
    Status
    Not applicable
    Location
    Clear Dermatology & Aesthetics Center /ID# 263626
    Scottsdale, Arizona, United States, 85260
    Status
    Not applicable
    Location
    Dermatology Trial Associates /ID# 264480
    Bryant, Arkansas, United States, 72022
    Status
    Not applicable
    Location
    First OC Dermatology /ID# 263003
    Fountain Valley, California, United States, 92708
    Status
    Not applicable
    Location
    Integrative Skin Science and Research /ID# 264504
    Sacramento, California, United States, 95815
    Status
    Not applicable
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