A Phase 3 Randomized Double-Blind Placebo-Controlled Study to Evaluate the Efficacy and Safety of Deucravacitinib in Participants with Active Systemic Lupus Erythematosus (POETYK-SLE-2)

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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 (POETYK-SLE-2)

Brief description of study

The 52-week double-blinded study is divided into 3 separate periods that will take about 60 weeks to complete: • Screening Period (4 weeks), • Treatment Period (52 weeks), and • Safety Follow-Up (4 weeks). • The Treatment Period is called a “Double-Blinded” or “Blinded” Treatment Period because neither you nor your study team will know whether you are getting deucravacitinib or placebo. There is a 50% chance of being on deucravacitinib and a 50% chance of being on placebo during this 52-week Treatment Period. Participants who complete the Treatment Period (either on deucravacitinib or placebo), may be able to enter into an optional Long-Term Extension (LTE) Period of up to 2 years (104 weeks). -

Clinical Study Identifier: s22-01331

ClinicalTrials.gov Identifier: NCT05620407

Principal Investigator: David H. Goddard.

Other Investigators: Jennifer Hill, Andres M. Piatti, Lauren E. Wong.

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