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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 Psoriatic Arthritis Who Are Naïve to Biologic Disease-modifying Anti-rheumatic Drugs

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Trial Profile

A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Deucravacitinib in Participants With Active Psoriatic Arthritis Who Are Naïve to Biologic Disease-modifying Anti-rheumatic Drugs

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 11 Aug 2025

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At a glance

  • Drugs Deucravacitinib (Primary)
  • Indications Plaque psoriasis; Psoriatic arthritis
  • Focus Registrational; Therapeutic Use
  • Acronyms POETYK PsA-1
  • Sponsors Bristol-Myers Squibb

Most Recent Events

  • 21 Jul 2025 According to a Bristol Myers Squibb media release, based on Phase 3 POETYK PsA-1 and POETYK PsA-2 clinical trials, the U.S. Food and Drug Administration (FDA) has accepted for review the supplemental New Drug Application (sNDA) for Sotyktu (deucravacitinib) for the treatment of adults with active psoriatic arthritis. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of March 6, 2026.
  • 11 Jun 2025 According to a Bristol Myers Squibb media release, data from this trial are being presented as a late-breaking abstract at the European Alliance of Associations for Rheumatology (EULAR) Congress.
  • 11 Jun 2025 Results published in the Bristol Myers Squibb Media Release

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