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Efficacy and Safety of Deucravacitinib Compared with Placebo in Participants with Active SLE (POETYK SLE-1)

This study will evaluate the safety and effectiveness of an oral medication called deucravacitinib as a therapeutic option for the treatment of patients with active systemic lupus erythematosus (SLE). Study participants could receive either the study medication or placebo for the 52 week treatment period of the study.

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Participation Requirements

  • Sex:

    Male, Female, Intersex

  • Eligible Ages:

    18 to 75

Participation Criteria

Inclusion Criteria:
Participants must be age 18 years to 75 year with a diagnosis of SLE at least 24 weeks prior to starting in the study. Please contact the study team for additional information about eligibility requirements.
Exclusion Criteria:
Patients with certain medical conditions are excluded from participating including:
- drug induced SLE
- SLE overlap syndromes e.g., rheumatoid arthritis (RA) or scleroderma
- other autoimmune diseases e.g., psoriasis, inflammatory bowl disease (IBD), celiac
disease, type 1 diabetes, multiple sclerosis (MS) or secondary Sjogren's syndrome.
- fibromyalgia and/or chronic fatigue syndrome
- increased risk of thrombosis (clots) e.g., unstable or untreated antiphospholipid antibody
syndrome (APS)

Certain medications and therapies are not permitted while in the study. Please contact the study team for more details.

Study Location

University of Calgary
University of Calgary
Calgary, Alberta
Canada

Contact Study Team

Study Sponsored By
University of Calgary
Participants Required
More Information
Study ID: REB23-0530