Clinical Research Details

Clinical Research

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)

Study Description

The POETYK SLE-1/SLE-2 (IM011-246/247) studies are two identical studies. If eligible, you will be enrolled in only one of these two studies. Participation may 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. Approximately 980 participants will be enrolled in the studies and will be randomized to receive either the investigational medication or a placebo to be taken orally, while remaining on your current standard-of-care treatment. Regardless of whether you are assigned to receive the investigational medication or the placebo, you will still receive the same level of study-related care.

Inclusion/Exclusion Criteria

Eligible participants must:
– Be 18 to 75 years of age
– Have a diagnosis of active SLE with signs and symptoms including joint
involvement and/or rash
– Have positive antibodies (ANA, or anti-dsDANA or anti-Smith) based on
laboratory screening
– Be receiving a background therapy for SLE, such as immunosuppressants
(azathioprine, 6-mercaptopurine, methotrexate, leflunomide, tacrolimus,
mizoribine, or mycophenolate mofetil) and/or antimalarials (chloroquine,
hydroxychloroquine, or quinacrine)
• Participants must not be taking more than one immunosuppressant
– NOT be diagnosed with other autoimmune diseases (e.g., multiple sclerosis,
psoriasis, inflammatory bowel disease, etc.)
• Exceptions: type 1 diabetes mellitus, thyroid autoimmune disease,
celiac disease, and secondary Sjögren’s syndrome
There are additional eligibility criteria, which your study doctor can explain to you.

Open Enrollment

Contact Name: Shannon Lloyd
Contact Phone: (904) 633-0071
Contact Email: shannon.lloyd@jax.ufl.edu

Investigators


Gurjit S. Kaeley, M.B.B.S. (M.D.)
Medicine