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Clinical Trials in the USA / NCT04857034
Active, not recruiting Phase 2

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

NCT04857034 · tracked via the Priya Life Science USA tracker
Sponsor
Bristol-Myers Squibb
Phase
Phase 2
Started
2021-07-12
Last updated
2025-09-10

Condition(s) studied

Lupus Erythematosus, DiscoidLupus Erythematosus, Subacute Cutaneous

Investigational drug(s) / intervention(s)

Deucravacitinib →Placebo

Deucravacitinib: Specified dose on specified days

Placebo: Specified dose on specified days

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (41)

FacilityCityRegionStatus
Local Institution - 0077 Scottsdale Arizona
Local Institution - 0076 Irvine California
Local Institution - 0046 Los Angeles California
Local Institution - 0073 Farmington Connecticut
Local Institution - 0082 Orlando Florida
Local Institution - 0060 Ann Arbor Michigan
Local Institution - 0059 St Louis Missouri
Local Institution - 0037 New York New York
Local Institution - 0065 Durham North Carolina
Local Institution - 0067 Columbus Ohio
Local Institution - 0026 Oklahoma City Oklahoma
Local Institution - 0054 Charleston South Carolina
Local Institution - 0018 Capital Federal Buenos Aires
Local Institution - 0013 San Miguel de Tucumán Tucumán Province
Local Institution - 0019 Buenos Aires Argentina
Local Institution - 0003 Botany New South Wales
Local Institution - 0001 Kogarah New South Wales
Local Institution - 0002 Camberwell Victoria
Local Institution - 0007 Clayton Victoria
Local Institution - 0078 Melbourne Victoria
Local Institution - 0087 Victoria Park Western Australia
Local Institution - 0038 Bordeaux France
Local Institution - 0027 Créteil France
Local Institution - 0010 Paris France
Local Institution - 0072 Dresden Saxony
Local Institution - 0035 Berlin Germany
Local Institution - 0014 Erlangen Germany
Local Institution - 0006 Hamburg Germany
Local Institution Guadalajara Jalisco
Local Institution - 0058 Zapopan Jalisco
Local Institution - 0036 Monterrey Nuevo León
Local Institution - 0029 Aguascalientes Mexico
Local Institution - 0028 Guadalajara Mexico
Local Institution - 0071 Mexico City Mexico
Local Institution - 0005 Rzeszów Poland
Local Institution - 0009 Wroclaw Poland
Local Institution - 0008 Lodz Łódź Voivodeship
Local Institution - 0031 Kaohsiung City Taiwan
Local Institution - 0023 Taichung Taiwan
Local Institution - 0021 Taichung Taiwan

+ 1 more sites — see the full list on the official registry below.

More Bristol-Myers Squibb trials in the USA

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04857034 on ClinicalTrials.gov ↗ ← All trials in the USA