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NCT Number: NCT04857034

A Study to Evaluate Efficacy and Safety of Deucravacitinib 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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Lupus Erythematosus, Discoid Connective Tissue Diseases Lupus Erythematosus, Cutaneous Lupus Erythematosus, Subacute Cutaneous Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Local Institution - 0018, Capital Federal, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Deucravacitinib

Drug

Specified dose on specified days

Placebo

Drug

Specified dose on specified days

Primary outcomes

  1. Percentage Change From Baseline in CLASI Activity Score at Week 16

    Time frame: From first dose to Week 16 (approximately 16 weeks)

    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

Secondary outcomes

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

    Time frame: From first dose to Week 16 (approximately 16 weeks)

    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

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

    Time frame: From first dose to Week 16 (approximately 16 weeks)

    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

  3. Mean Change From Baseline in CLASI-A Score.

    Time frame: From first dose to Week 16 (approximately 16 weeks)

    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

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

    Time frame: From first dose to Week 16 (approximately 16 weeks)

    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".

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

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

    Number of participants with safety related events in the placebo controlled period

  6. Number of Participants With Safety Related Events in the Active Treatment Period

    Time frame: 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

  7. Number of Participants With Clinically Significant Laboratory Abnormalities in the Placebo Controlled Period

    Time frame: 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

  8. Number of Participants With Clinically Significant Laboratory Abnormalities in the Active Treatment Period

    Time frame: 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

  9. Number of Participants With Clinically Significant Vital Sign Abnormalities in the Placebo Controlled Period

    Time frame: 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

  10. Number of Participants With Clinically Significant Vital Sign Abnormalities in the Active Treatment Period

    Time frame: 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

  11. Number of Participants With Clinically Significant ECG Abnormalities in the Placebo Controlled Period

    Time frame: From signing informed consent to end of active treatment period (Approximately 56 weeks)

    Number of participants with clinically significant ECG abnormalities in the placebo controlled period

  12. Number of Participants With Clinically Significant ECG Abnormalities in the Active Treatment Period

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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)

Important dates

Study start
2021
Primary completion
2024
Study completion
2028
First posted
Apr 23, 2021
Registry last updated
Sep 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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