A Study to Evaluate Efficacy and Safety of Deucravacitinib in Participants With Active Discoid and/or Subacute Cutaneous Lupus Erythematosus (DLE/SCLE)
Part of paid clinical trials in Scottsdale, Arizona.
- Sponsor
- Bristol-Myers Squibb
- Study ID
- NCT04857034
- Phase
- PHASE2
- Status
- Active Not Recruiting
Conditions
- Lupus Erythematosus, Discoid
- Lupus Erythematosus, Subacute Cutaneous
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 75 Years
- Healthy Volunteers
- Not accepted
Interventions
- Deucravacitinib — DRUGSpecified dose on specified days
- Placebo — DRUGSpecified dose on specified days
Study Details
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.
Key Dates
- Start date
- Jul 12, 2021
- Status verified
- Aug 2025
- Primary completion
- Aug 22, 2024
- Completion
- Feb 28, 2028
Study Design
- Enrollment
- 74 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Active Treatment: Deucravacitinib Dose 1
- Experimental: Active Treatment: Deucravacitinib Dose 2
- Placebo Comparator: Placebo
Primary Outcome Measure
Percentage Change From Baseline in CLASI Activity Score at Week 16 [ Time Frame: From first dose to Week 16 (approximately 16 weeks) ]
Locations (12)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Local Institution - 0077 | Scottsdale | Arizona | 85259 | - |
| Local Institution - 0076 | Irvine | California | 92697 | - |
| Local Institution - 0046 | Los Angeles | California | 90045 | - |
| Local Institution - 0073 | Farmington | Connecticut | 06030 | - |
| Local Institution - 0082 | Orlando | Florida | 32827 | - |
| Local Institution - 0060 | Ann Arbor | Michigan | 48109 | - |
| Local Institution - 0059 | St Louis | Missouri | 63108 | - |
| Local Institution - 0037 | New York | New York | 10029 | - |
| Local Institution - 0065 | Durham | North Carolina | 27713 | - |
| Local Institution - 0067 | Columbus | Ohio | 43215 | - |
| Local Institution - 0026 | Oklahoma City | Oklahoma | 73104 | - |
| Local Institution - 0054 | Charleston | South Carolina | 29407 | - |
Related coverage on Hipa.ai
- Deucravacitinib Improves CLASI Activity in Discoid and Subacute Cutaneous LupusDeucravacitinib · Sep 10, 2025 · ClinicalTrials.gov