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

Currently recruiting participants: Yes

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

Method of contact

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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