Efficacy and Safety of Deucravacitinib Compared with Placebo in Participants with Active SLE (POETYK SLE-2)
EU CTIS ID: 2022-500700-22-00
What this study is testing
To demonstrate superiority of deucravacitinib compared to PBO in treatment of participants with SLE with respect to SRI (4).
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Male and female participants aged 18(or local age of majority, if older) to 75 years of age, inclusive, diagnosed with SLE at least 24 weeks prior to screening and meet the European Alliance of Associations for Rheumatology/American College of Rheumatology 2019 classification criteria for SLE. Participants must test positive for at least 1 of the following lupus-related autoantibodies at the time of screening: antinuclear antibodies (ANA)≥ 1:80, anti-dsDNA antibody, or anti-Smith (anti- Sm). Participants must have active lupus defined as a total SLEDAI-2K score≥6 points, and clinical SLEDAI-2K score ≥ 4 points, and must include joint involvement and/or cutaneous vasculitis, and/or rash. Participants must be on stable background therapy with anti-malarial agents and/or immunosuppressants. Participants may also be on corticosteroids.
You likely can't join if
- Participants with any of the following diagnoses are excluded: drug induced SLE, most autoimmune disease (e.g. multiple sclerosis, inflammatory bowel disease, etc), SLE overlap syndromes including rheumatoid arthritis, scleroderma and mixed connective tissue disease, catastrophic anti-phospholipid syndrome or anti-phospholipid syndrome not maintained on appropriate therapy, or there has been a thrombotic event or pregnancy morbidity, active severe lupus nephritis, active severe neuropsychiatric lupus, congenital or acquired immunodeficiency condition. Participants on investigational agents or prohibited immunomodulatory or biologics medications within applicable wash-out period are excluded. Participants using prohibited corticosteroid formulations or prohibited routes of administration (e.g. modified release CS formulation, high-potency topic CS, intramuscular, intra-articular, intra-bursal, and IV), receiving therapy for active or chronic infection are also excluded.
The study team makes the final eligibility decision.
Where it's taking place
- Argentina
- Brazil
- Taiwan
- Peru
- Japan
- United States
- Australia
- Singapore
- Chile
- United Kingdom
- Mexico
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Argentina; Brazil; Taiwan; Peru; Japan; United States and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.