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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-2)

IRB Number: 2023-0229

May 31, 2024

Institutional Review Board, Hospital for Special Surgery

The safety of our participants is our top priority. The trial/study is approved and periodically reviewed by the Institutional Review Board (IRB), which includes doctors, administrators, ethicists, and members of the general public. The safety of clinical trials is reviewed by the U.S. Food and Drug Administration.

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For further information, see Understanding Clinical Trials/Research Studies.

Principal Investigator

Kyriakos A. Kirou, MD, DSc, FACP


David R. Fernandez, MD, PhD
Romy Kallas, MD


POETYK SLE-2 (IM011-247) is being done to learn about the effectiveness and safety of deucravacitinib in adults with systemic lupus erythematosus (SLE). Participation in the POETYK SLE-2 (IM011-247) study will last between approximately 14 and 38 months and consists of a screening period, a double-blind treatment period, an optional open-label long-term extension period, and a follow-up period. Participants will receive deucravacitinib (60% chance) or matching placebo (40% chance) as oral tablets to be taken twice daily during the double-blind period. All participants will receive deucravacitinib during the optional open-label long-term extension period.

Deucravacitinib is an oral selective allosteric inhibitor of tyrosine kinase 2 (TYK 2). Deucravacitinib is approved for moderate to severe plaque psoriasis in multiple countries based on two large phase 3 studies of 1,681 people with psoriasis. Deucravacitinib is not approved for the treatment of SLE. Deucravacitinib is being evaluated in the POETYK SLE-2 study as a therapy for patients with SLE based on results from a previous phase 2 study of deucravacitinib in SLE. Research indicates that deucravacitinib modulates inflammatory markers of SLE disease progression and significantly inhibits type 1 interferon activity, a primary driver of SLE disease. In a phase 2 study, deucravacitinib significantly improved SRI-4 at Week 32, as well as SRI-4, BICLA, LLDAS, CLASI-50, and changes in active, swollen and tender joint counts, at Week 48 in patients with active SLE compared to placebo. It is not known if similar results will be achieved in the phase 3 studies. The POETYK SLE-2 (IM011-247) study will evaluate the efficacy and safety of deucravacitinib for individuals with SLE.

Inclusion/Exclusion Criteria

Inclusion criteria
•    18 to 75 years of age 
•    Diagnosed with active SLE at least 24 weeks before screening 
•    Meets the EULAR/ACR 2019 classification criteria for SLE 
•    Have positive autoantibodies (ANA, or anti-dsDNA or anti-Smith) based on central laboratory screening 
•    Active SLE as measured by SLEDAI-2K ≥ 6 and a clinical SLEDAI-2K ≥ 4 with joint involvement and/or cutaneous vasculitis and/or rash 
•    Receiving at least 1 SLE background therapy (immunosuppressant and/or antimalarial) 

Exclusion criteria 
Diagnosis of any of the following: 
•    Drug-induced SLE 
•    Other autoimmune diseases (e.g., multiple sclerosis, psoriasis, inflammatory bowel disease) 
o    Exceptions: type 1 diabetes mellitus, thyroid autoimmune disease, celiac disease, and secondary Sjögren’s syndrome 
•    Active or unstable lupus neuropsychiatric manifestations, including but not limited to any condition defined by BILAG A criteria 
•    Active Class III or IV lupus nephritis that requires or may require treatment with cytotoxic agents or high-dose CS

Contact Information

Emily Wu, Research Coordinator