This clinical trial, POETYK SLE-2 (IM011247), is a Phase 3 global study evaluating the efficacy and safety of an investigational medication called deucravacitinib for adults living with active Systemic Lupus Erythematosus (SLE).
About the Study
The study is a randomized, double-blind, placebo-controlled trial. This means that half of the participants will receive the study drug, while the other half will receive a placebo (a treatment with no active medicine). Neither the participants nor the medical team will know which treatment is being administered during the primary 52-week treatment period.
The primary goal of the study is to determine if deucravacitinib is more effective than a placebo at reducing Lupus disease activity when added to standard background therapy.
What is Deucravacitinib?
Deucravacitinib (BMS-986165) is a highly selective “TYK2 inhibitor”. It works by blocking the signals of specific proteins (type I interferon, IL-23, and IL-12) that are known to drive the inflammation and immune system overactivity found in Lupus. Unlike some other treatments, this medication is taken as an oral tablet once daily.
Who Can Participate?
The trial is looking for approximately 490 to 550 participants globally. Key eligibility criteria include:
Age: 18 to 75 years old.
Diagnosis: A confirmed diagnosis of SLE for at least 24 weeks prior to joining the study.
Disease Activity: Must have active moderate-to-severe disease (defined by specific clinical scores like SLEDAI-2K) despite receiving stable standard treatments.
Background Therapy: Participants must be on a stable dose of at least one standard SLE treatment (such as antimalarials or immunosuppressants).
Study Timeline
Screening Period: Up to 4 weeks to determine eligibility.
Treatment Period: 52 weeks of once-daily dosing.
Optional Extension: Participants who complete the first 52 weeks may have the opportunity to enter a Long-Term Extension (LTE) period of up to 104 weeks, where all participants receive the active study drug.
Follow-up: A safety follow-up visit approximately 4 weeks after the last dose.