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

NCT04857034 | Active Not Recruiting Phase 2 Results DMC FDA Drug

• 3 other identifiers: IM011-1322020-000071-21U1111-1246-1726
• Study Type: interventional
• Target: 74
• Locations: 8 countries
• Sites: 41

Brief 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

Keywords

BMS-986165; Deucravacitinib; DLE; Discoid Lupus Erythematosus; SCLE; Subacute Cutaneous Lupus Erythematosus

Outcome Measures

Primary Outcomes (1)

• Percentage Change From Baseline in CLASI Activity Score at Week 16

  The Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) is a validated clinical tool designed to assess skin involvement in cutaneous lupus erythematosus (CLE). It separately scores: * Disease activity (e.g., erythema, scale, mucous membrane involvement, alopecia) * Damage (e.g., dyspigmentation, scarring) CLASI enables classification of disease severity: Mild: Activity score 0-9 Moderate: 10-20 Severe: 21-70

  From first dose to Week 16 (approximately 16 weeks)

Secondary Outcomes (12)

• Percentage of Participants With an Improvement of ≥ 50% From Baseline in the CLASI-A Score (CLASI-50).

  From first dose to Week 16 (approximately 16 weeks)

• Percentage of Participants Who Have Disease Improvement as Defined by a Reduction in CLASI-A of ≥ 4 Points From Baseline.

  From first dose to Week 16 (approximately 16 weeks)

• Mean Change From Baseline in CLASI-A Score.

  From first dose to Week 16 (approximately 16 weeks)

• Percentage of Participants Who Have a Complete Response (CR) on CLASI-A Defined as a Score of "0".

  From first dose to Week 16 (approximately 16 weeks)

• Number of Participants With Safety Related Events in the Placebo Controlled Period

  From signing informed consent to end of safety follow up period (Approximately 60 weeks)

Study Arms (3)

Active Treatment: Deucravacitinib Dose 1

EXPERIMENTAL

Drug: Deucravacitinib

Active Treatment: Deucravacitinib Dose 2

EXPERIMENTAL

Drug: Deucravacitinib

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Deucravacitinib DRUG

Specified dose on specified days

Active Treatment: Deucravacitinib Dose 1; Active Treatment: Deucravacitinib Dose 2

Placebo DRUG

Specified dose on specified days

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of discoid/subacute cutaneous lupus erythematosus (DLE/SCLE) for at least 3 months prior to screening visit
• Meets both clinical and histopathological diagnostic cutaneous lupus erythematosus (CLE) criteria per protocol
• Currently receiving treatment for DLE/SCLE with a stable regimen of at least one of the following medications: oral corticosteroid, and/or antimalarial, and/or immunosuppressant
• Participant could be with or without concurrent systemic lupus erythematosus (SLE)
• If participant receives nonsteroidal anti-inflammatory drugs (NSAIDs) or analgesics treatment then the participant must be on a stable dose 2 weeks prior to screening

You may not qualify if:

• Women who are pregnant, lactating, breastfeeding or planning pregnancy during the study period
• Any of the following specific CLE subtypes in isolation: acute cutaneous lupus erythematosus (ACLE), lupus tumidus, lupus (profundus) panniculitis, chilblains
• Drug-induced CLE and/or drug-induced systemic lupus erythematosus (SLE)
• Antiphospholipid antibody syndrome, serious thrombotic event or unexplained pregnancy loss within 1 year before the screening visit
• History of 3 or more unexplained consecutive pregnancy losses
• Active severe or unstable neuropsychiatric SLE
• Other autoimmune diseases or non-SLE driven inflammatory joint or skin disease or overlap syndromes as primary disease that in the opinion of the investigator will significantly impact the assessment of CLE/SLE disease manifestations and activity

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (41)

Local Institution - 0077

Scottsdale, Arizona, 85259, United States

Location

Local Institution - 0076

Irvine, California, 92697, United States

Location

Local Institution - 0046

Los Angeles, California, 90045, United States

Location

Local Institution - 0073

Farmington, Connecticut, 06030, United States

Location

Local Institution - 0082

Orlando, Florida, 32827, United States

Location

Local Institution - 0060

Ann Arbor, Michigan, 48109, United States

Location

Local Institution - 0059

St Louis, Missouri, 63108, United States

Location

Local Institution - 0037

New York, New York, 10029, United States

Location

Local Institution - 0065

Durham, North Carolina, 27713, United States

Location

Local Institution - 0067

Columbus, Ohio, 43215, United States

Location

Local Institution - 0026

Oklahoma City, Oklahoma, 73104, United States

Location

Local Institution - 0054

Charleston, South Carolina, 29407, United States

Location

Local Institution - 0018

Capital Federal, Buenos Aires, 1023, Argentina

Location

Local Institution - 0013

San Miguel de Tucumán, Tucumán Province, 4000, Argentina

Location

Local Institution - 0019

Buenos Aires, 1431, Argentina

Location

Local Institution - 0003

Botany, New South Wales, 2019, Australia

Location

Local Institution - 0001

Kogarah, New South Wales, 2217, Australia

Location

Local Institution - 0002

Camberwell, Victoria, 3124, Australia

Location

Local Institution - 0007

Clayton, Victoria, 0, Australia

Location

Local Institution - 0078

Melbourne, Victoria, 3004, Australia

Location

Local Institution - 0087

Victoria Park, Western Australia, 6100, Australia

Location

Local Institution - 0038

Bordeaux, 33075, France

Location

Local Institution - 0027

Créteil, 94000, France

Location

Local Institution - 0010

Paris, 75970, France

Location

Local Institution - 0072

Dresden, Saxony, 01307, Germany

Location

Local Institution - 0035

Berlin, 10117, Germany

Location

Local Institution - 0014

Erlangen, 91054, Germany

Location

Local Institution - 0006

Hamburg, 22391, Germany

Location

Local Institution

Guadalajara, Jalisco, 45030, Mexico

Location

Local Institution - 0058

Zapopan, Jalisco, 45070, Mexico

Location

Local Institution - 0036

Monterrey, Nuevo León, 64718, Mexico

Location

Local Institution - 0029

Aguascalientes, 20130, Mexico

Location

Local Institution - 0028

Guadalajara, 0, Mexico

Location

Local Institution - 0071

Mexico City, 14080, Mexico

Location

Local Institution - 0005

Rzeszów, 35-055, Poland

Location

Local Institution - 0009

Wroclaw, 50-566, Poland

Location

Local Institution - 0008

Lodz, Łódź Voivodeship, 94-046, Poland

Location

Local Institution - 0031

Kaohsiung City, 833, Taiwan

Location

Local Institution - 0023

Taichung, 402, Taiwan

Location

Local Institution - 0021

Taichung, 404, Taiwan

Location

Local Institution - 0022

Taipei, 10051, Taiwan

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Lupus Erythematosus, Discoid; Lupus Erythematosus, Cutaneous

Interventions

deucravacitinib

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Results Point of Contact

• Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

please email

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2021
• First Posted: April 23, 2021
• Study Start: July 12, 2021
• Primary Completion: August 22, 2024
• Study Completion (Estimated): February 28, 2028
• Last Updated: September 10, 2025
• Results First Posted: September 10, 2025

Record last verified: 2025-08

Locations

ME (6); AR (3); US (12); AU (6); DE (4); PL (3); TW (4); FR (3)