NCT04857034

A Study to Evaluate Efficacy and Safety of Deucravacitinib in Participants With Active Discoid and/or Subacute Cutaneous Lupus Erythematosus (DLE/SCLE)

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of Deucravacitinib (BMS-986165) in Participants With Active Discoid and/or Subacute Cutaneous Lupus Erythematosus (DLE/SCLE)

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the safety, efficacy, and tolerability of deucravacitinib (BMS-986165) compared with placebo in participants with active discoid and/or subacute cutaneous lupus erythematosus (DLE/SCLE). This study will also assess if deucravacitinib is biologically active and potentially effective in the treatment of participants with moderate to severe DLE/SCLE with or without systemic lupus erythematosus (SLE) that is not well controlled with standard of care therapy.

Conditions

• Lupus Erythematosus, Discoid
• Lupus Erythematosus, Subacute Cutaneous

Interventions

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

Timeline

• Start date: 2021-07-12
• Primary completion: 2024-08-22
• Completion: 2028-02-28
• First posted: 2021-04-23
• Last updated: 2025-09-10
• Results posted: 2025-09-10

Locations

41 sites across 8 countries: United States, Argentina, Australia, France, Germany, Mexico, Poland, Taiwan

Regulatory

• FDA-regulated drug study