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)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Lupus Erythematosus, Discoid; Lupus Erythematosus, Subacute Cutaneous
• Intervention / Treatment: Drug: Deucravacitinib; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 74
• Phase: Phase 2

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, 1431
    • Local Institution - 0019
  • Buenos Aires
    • Capital Federal, Buenos Aires, Argentina, 1023
      • Local Institution - 0018
  • Tucumán Province
    • San Miguel de Tucumán, Tucumán Province, Argentina, 4000
      • Local Institution - 0013
• Australia
  • New South Wales
    • Botany, New South Wales, Australia, 2019
      • Local Institution - 0003
    • Kogarah, New South Wales, Australia, 2217
      • Local Institution - 0001
  • Victoria
    • Camberwell, Victoria, Australia, 3124
      • Local Institution - 0002
    • Clayton, Victoria, Australia
      • Local Institution - 0007
    • Melbourne, Victoria, Australia, 3004
      • Local Institution - 0078
  • Western Australia
    • Victoria Park, Western Australia, Australia, 6100
      • Local Institution - 0087
• France
  • Bordeaux, France, 33075
    • Local Institution - 0038
  • Créteil, France, 94000
    • Local Institution - 0027
  • Paris, France, 75970
    • Local Institution - 0010
• Germany
  • Berlin, Germany, 10117
    • Local Institution - 0035
  • Erlangen, Germany, 91054
    • Local Institution - 0014
  • Hamburg, Germany, 22391
    • Local Institution - 0006
  • Saxony
    • Dresden, Saxony, Germany, 01307
      • Local Institution - 0072
• Mexico
  • Aguascalientes, Mexico, 20130
    • Local Institution - 0029
  • Guadalajara, Mexico
    • Local Institution - 0028
  • Mexico City, Mexico, 14080
    • Local Institution - 0071
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 45030
      • Local Institution
    • Zapopan, Jalisco, Mexico, 45070
      • Local Institution - 0058
  • Nuevo León
    • Monterrey, Nuevo León, Mexico, 64718
      • Local Institution - 0036
• Poland
  • Rzeszów, Poland, 35-055
    • Local Institution - 0005
  • Wroclaw, Poland, 50-566
    • Local Institution - 0009
  • Łódź Voivodeship
    • Lodz, Łódź Voivodeship, Poland, 94-046
      • Local Institution - 0008
• Taiwan
  • Kaohsiung City, Taiwan, 833
    • Local Institution - 0031
  • Taichung, Taiwan, 404
    • Local Institution - 0021
  • Taichung, Taiwan, 402
    • Local Institution - 0023
  • Taipei, Taiwan, 10051
    • Local Institution - 0022
• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85259
      • Local Institution - 0077
  • California
    • Irvine, California, United States, 92697
      • Local Institution - 0076
    • Los Angeles, California, United States, 90045
      • Local Institution - 0046
  • Connecticut
    • Farmington, Connecticut, United States, 06030
      • Local Institution - 0073
  • Florida
    • Orlando, Florida, United States, 32827
      • Local Institution - 0082
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Local Institution - 0060
  • Missouri
    • St Louis, Missouri, United States, 63108
      • Local Institution - 0059
  • New York
    • New York, New York, United States, 10029
      • Local Institution - 0037
  • North Carolina
    • Durham, North Carolina, United States, 27713
      • Local Institution - 0065
  • Ohio
    • Columbus, Ohio, United States, 43215
      • Local Institution - 0067
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • Local Institution - 0026
  • South Carolina
    • Charleston, South Carolina, United States, 29407
      • Local Institution - 0054

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Other protocol-defined inclusion/exclusion criteria apply

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Specified dose on specified days
Experimental: Active Treatment: Deucravacitinib Dose 1	Drug: Deucravacitinib; Specified dose on specified days
Experimental: Active Treatment: Deucravacitinib Dose 2	Drug: Deucravacitinib; Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With an Improvement of ≥ 50% From Baseline in the CLASI-A Score (CLASI-50).	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)
Percentage of Participants Who Have Disease Improvement as Defined by a Reduction in CLASI-A of ≥ 4 Points From Baseline.	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)
Mean Change From Baseline in CLASI-A Score.	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)
Percentage of Participants Who Have a Complete Response (CR) on CLASI-A Defined as a Score of "0".	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 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	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)
Number of Participants With Safety Related Events in the Active Treatment Period	Number of participants with safety related events in the active treatment period	From signing informed consent to end of safety follow up period (Approximately 60 weeks)
Number of Participants With Clinically Significant Laboratory Abnormalities in the Placebo Controlled Period	Number of participants with clinically significant laboratory abnormalities in the placebo controlled period	From signing informed consent to end of safety follow up period (Approximately 60 weeks)
Number of Participants With Clinically Significant Laboratory Abnormalities in the Active Treatment Period	Number of participants with clinically significant laboratory abnormalities in the active treatment period	From signing informed consent to end of safety follow up period (Approximately 60 weeks)
Number of Participants With Clinically Significant Vital Sign Abnormalities in the Placebo Controlled Period	Number of participants with clinically significant vital sign abnormalities in the placebo controlled period	From signing informed consent to end of safety follow up period (Approximately 60 weeks)
Number of Participants With Clinically Significant Vital Sign Abnormalities in the Active Treatment Period	Number of participants with clinically significant vital sign abnormalities in the active treatment period	From signing informed consent to end of safety follow up period (Approximately 60 weeks)
Number of Participants With Clinically Significant ECG Abnormalities in the Placebo Controlled Period	Number of participants with clinically significant ECG abnormalities in the placebo controlled period	From signing informed consent to end of active treatment period (Approximately 56 weeks)
Number of Participants With Clinically Significant ECG Abnormalities in the Active Treatment Period	Number of participants with clinically significant ECG abnormalities in the active treatment period	From signing informed consent to end of active treatment period (Approximately 56 weeks)

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Investigators: Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

Study record dates

Study Major Dates

• Study Start (Actual): July 12, 2021
• Primary Completion (Actual): August 22, 2024
• Study Completion (Estimated): February 28, 2028

Study Registration Dates

• First Submitted: April 20, 2021
• First Submitted That Met QC Criteria: April 20, 2021
• First Posted (Actual): April 23, 2021

Study Record Updates

• Last Update Posted (Estimated): September 10, 2025
• Last Update Submitted That Met QC Criteria: August 21, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Deucravacitinib; BMS-986165; Discoid Lupus Erythematosus; DLE; SCLE; Subacute Cutaneous Lupus Erythematosus
• Additional Relevant MeSH Terms: Connective Tissue Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Lupus Erythematosus, Cutaneous; Lupus Erythematosus, Discoid; Substandard Drugs; Pharmaceutical Preparations; Counterfeit Drugs; deucravacitinib
• Other Study ID Numbers: IM011-132; 2020-000071-21 (EudraCT Number); U1111-1246-1726 (Registry Identifier: WHO)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No