Efficacy and Safety of Deucravacitinib Compared with Placebo in Participants with Active SLE (POETYK SLE-1)
Key facts
- Where
- Bialystok, Bydgoszcz, Cracow, Katowice, Lublin, Nadarzyn, Poznan és Warsaw, LengyelországSee the 10 sites
- Phase
- 3. fázis
Where in Lengyelország
- Nova Reuma Domyslawska I Rusilowicz Lekarza Reumatologa I Fizjoterapeuty sp.p.Bialystok, LengyelországNo longer taking part
- Szpital Uniwersytecki nr 2 im dr Jana Biziela w BydgoszczyBydgoszcz, LengyelországNo longer taking part
- Centrum Medyczne Plejady Sp. z o.o. S.K.Cracow, LengyelországNo longer taking part
- Centrum Medyczne Pratia KatowiceKatowice, LengyelországNo longer taking part
- Velocity Nova Sp. z o.o.Lublin, LengyelországNo longer taking part
- Mak-Med Clinic Sp. z o.o.Nadarzyn, LengyelországNo longer taking part
- Medyczne Centrum Hetmańska Piotr LeszczyńskiPoznan, LengyelországNo longer taking part
- Synexus Polska Sp z o oPoznan, LengyelországNo longer taking part
- Narodowy Instytut Geriatrii Reumatologii I Rehabilitacji Im Prof. Dr Hab. Med. Eleonory ReicherWarsaw, LengyelországNo longer taking part
- Rheuma Medicus Sp z o oWarsaw, LengyelországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Bristol-Myers Squibb Services Unlimited Company
- Trial code
- EU 2022-500699-76-00
- Record updated
- 2026. szeptember 21.
- Original description
To demonstrate superiority of deucravacitinib compared to PBO in treatment of participants with SLE with respect to SRI (4).Read full original descriptionShow less
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Deucravacitinib in Participants with Active Systemic Lupus Erythematosus (SLE) (POETYK SLE-1)
To demonstrate superiority of deucravacitinib compared to PBO in treatment of participants with SLE with respect to SRI (4).
Inclusion: 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.
Exclusion: 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.