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Trial ID IM011-132  |   NCT04857034

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

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Summary

  • Phase 2
  • Male and Female Gender icon
  • 18-75
    Age Range
  • BMS Active Not Yet Recruiting Study icon
    Active, Not Recruiting

Overview

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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Key Eligibility Criteria

Inclusion Criteria

Inclusion Criteria Icon img
:
  • Diagnosis of discoid/subacute cutaneous lupus erythematosus (DLE/SCLE) for at least 3 months prior to screening visit
    1. Meets both clinical and histopathological diagnostic cutaneous lupus erythematosus (CLE) criteria per protocol
      1. 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
        1. Participant could be with or without concurrent systemic lupus erythematosus (SLE)
          1. 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

            Exclusion Criteria Icon
            :
            • Women who are pregnant, lactating, breastfeeding or planning pregnancy during the study period
              1. Any of the following specific CLE subtypes in isolation: acute cutaneous lupus erythematosus (ACLE), lupus tumidus, lupus (profundus) panniculitis, chilblains
                1. Drug-induced CLE and/or drug-induced systemic lupus erythematosus (SLE)
                  1. Antiphospholipid antibody syndrome, serious thrombotic event or unexplained pregnancy loss within 1 year before the screening visit
                    1. History of 3 or more unexplained consecutive pregnancy losses
                      1. Active severe or unstable neuropsychiatric SLE
                        1. 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
                          Additional Information *

                          Treatment Options

                          Study Arms

                          ASSIGNED INTERVENTION

                          Study Arms

                          Experimental: Active Treatment: Deucravacitinib Dose 1

                          ASSIGNED INTERVENTION
                          • Drug: Deucravacitinib

                          Study Arms

                          Experimental: Active Treatment: Deucravacitinib Dose 2

                          ASSIGNED INTERVENTION
                          • Drug: Deucravacitinib

                          Study Arms

                          Placebo Comparator: Placebo

                          ASSIGNED INTERVENTION
                          • Drug: Placebo

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