Efficacy and Safety of Deucravacitinib Compared with Placebo in Participants with Active SLE (POETYK SLE-1)
Summary
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.
Eligibility
Eligible gender: Male, Female, Transgender, Other
Eligible ages: 18 to 75
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.
Participate
Fill out the following form if you want to participate in this research
Collection of personal information
Your personal information is collected under
the authority of section 33(c) of the Freedom of Information and Protection of Privacy Act. If
you have any questions about the collection or use of this information, please visit our
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Additional information
Contact information
For more information please reach out to the study team.
Principal investigator:
Ann Clarke
Clinical trial:
Yes
REB-ID:
REB23-0530