NCT04908189

A Study to Determine the Efficacy and Safety of Deucravacitinib Compared With Placebo in Participants With Active Psoriatic Arthritis (PsA) Who Are Naïve to Biologic Disease Modifying Anti-rheumatic Drugs or Had Previously Received TNFα Inhibitor Treatment

A Multi-center, Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate the Efficacy and Safety of Deucravacitinib in Participants With Active Psoriatic Arthritis (PsA) Who Are Naïve to Biologic Disease Modifying Anti-rheumatic Drugs or Had Previously Received TNFα Inhibitor Treatment

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 729 (actual)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and efficacy of deucravacitinib versus placebo for the treatment of participants with active PsA who are naïve to biologic disease modifying antirheumatic drugs or had previously received TNFα inhibitor treatment.The long term extension period will provide additional long-term safety and efficacy information.

Conditions

• Psoriatic Arthritis

Interventions

Type	Name	Description
DRUG	Deucravacitinib	Specified dose on specified days
OTHER	Placebo	Specified dose on specified days
DRUG	Apremilast	Specified dose on specified days

Timeline

• Start date: 2021-07-15
• Primary completion: 2024-02-06
• Completion: 2026-11-12
• First posted: 2021-06-01
• Last updated: 2025-06-13
• Results posted: 2025-04-13

Locations

138 sites across 18 countries: United States, Argentina, Australia, Belgium, Canada, China, Colombia, Czechia, Germany, Hungary, Italy, Japan, Mexico, Poland, Russia, Spain, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study