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

Last updated: November 18, 2024
Sponsor: Bristol-Myers Squibb
Overall Status: Active - Not Recruiting

Phase

2

Condition

Systemic Lupus Erythematosus

Lupus

Discoid Lupus Erythematosus (Dle)

Treatment

Deucravacitinib

Placebo

Clinical Study ID

NCT04857034
IM011-132
U1111-1246-1726
2020-000071-21
  • Ages 18-75
  • All Genders

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 Criteria

Inclusion

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 ofthe following medications: oral corticosteroid, and/or antimalarial, and/orimmunosuppressant

  • Participant could be with or without concurrent systemic lupus erythematosus (SLE)

  • If participant receives nonsteroidal anti-inflammatory drugs (NSAIDs) or analgesicstreatment then the participant must be on a stable dose 2 weeks prior to screening

Exclusion

Exclusion Criteria:

  • Women who are pregnant, lactating, breastfeeding or planning pregnancy during thestudy period

  • Any of the following specific CLE subtypes in isolation: acute cutaneous lupuserythematosus (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 unexplainedpregnancy 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 oroverlap syndromes as primary disease that in the opinion of the investigator willsignificantly impact the assessment of CLE/SLE disease manifestations and activity

Other protocol-defined inclusion/exclusion criteria apply

Study Design

Total Participants: 75
Treatment Group(s): 2
Primary Treatment: Deucravacitinib
Phase: 2
Study Start date:
July 12, 2021
Estimated Completion Date:
February 28, 2028

Connect with a study center

  • Centro de Educación Médica e Investigaciones Clínicas (CEMIC)-Rheumatology

    C.a.b.a., Buenos Aires 1431
    Argentina

    Site Not Available

  • Stat Research S.A.-Dermatology

    Caba, Buenos Aires C1023AAB
    Argentina

    Site Not Available

  • Local Institution - 0018

    Capital Federal, Buenos Aires 1023
    Argentina

    Site Not Available

  • Stat Research S.A.-Dermatology

    Capital Federal, Buenos Aires 1023
    Argentina

    Active - Recruiting

  • Local Institution - 0020

    Córdoba, Cordoba 5004
    Argentina

    Site Not Available

  • Local Institution - 0013

    San Miguel De Tucuman, Tucuman 4000
    Argentina

    Site Not Available

  • Local Institution

    San Miguel de Tucumán, Tucuman T4000
    Argentina

    Site Not Available

  • Centro de Educación Médica e Investigaciones Clínicas (CEMIC)-Rheumatology

    Buenos Aires, 1431
    Argentina

    Site Not Available

  • Local Institution - 0019

    Buenos Aires, 1431
    Argentina

    Site Not Available

  • Local Institution

    Cordoba,
    Argentina

    Site Not Available

  • Local Institution - 0003

    Botany, New South Wales 2019
    Australia

    Site Not Available

  • Local Institution - 0001

    Kogarah, New South Wales 2217
    Australia

    Site Not Available

  • Local Institution

    Sydney, New South Wales 2217
    Australia

    Site Not Available

  • Local Institution - 0002

    Camberwell, Victoria 3124
    Australia

    Site Not Available

  • Local Institution - 0011

    Carlton, Victoria 3053
    Australia

    Site Not Available

  • Local Institution - 0007

    Clayton, Victoria 0
    Australia

    Site Not Available

  • Local Institution - 0078

    Melbourne, Victoria 3004
    Australia

    Site Not Available

  • The Alfred Hospital

    Melbourne, Victoria 3004
    Australia

    Site Not Available

  • Local Institution - 0087

    Victoria Park, Western Australia 6100
    Australia

    Site Not Available

  • RK Will Pty Ltd

    Victoria Park, Western Australia 6100
    Australia

    Site Not Available

  • CHU de Bordeaux Hop St ANDRE-Service de Dermatologie

    Bordeaux, 33075
    France

    Site Not Available

  • Local Institution - 0038

    Bordeaux, 33075
    France

    Site Not Available

  • HENRI MONDOR HOSPITAL-dermatology

    Creteil, 94000
    France

    Site Not Available

  • HENRI MONDOR HOSPITAL-dermatology

    Créteil, 94000
    France

    Site Not Available

  • Local Institution - 0027

    Créteil, 94000
    France

    Site Not Available

  • Hôpital Tenon-Dermatology and allergology

    Paris, 75970
    France

    Site Not Available

  • Local Institution - 0010

    Paris, 75970
    France

    Site Not Available

  • Local Institution

    Strasbourg, 67098
    France

    Site Not Available

  • Local Institution - 0072

    Dresden, Sachsen 01307
    Germany

    Site Not Available

  • Universitaetsklinikum Carl Gustav Carus Dresden

    Dresden, Sachsen 01307
    Germany

    Site Not Available

  • Charité Universitaetsmedizin Berlin - Campus Mitte

    Berlin, 10117
    Germany

    Site Not Available

  • Local Institution - 0035

    Berlin, 10117
    Germany

    Site Not Available

  • Local Institution - 0014

    Erlangen, 91054
    Germany

    Site Not Available

  • Universitaetsklinikum Erlangen-Hautklinik

    Erlangen, 91054
    Germany

    Active - Recruiting

  • Local Institution - 0006

    Hamburg, 22391
    Germany

    Site Not Available

  • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

    Mexico City, Distrito Federal 14080
    Mexico

    Active - Recruiting

  • Local Institution

    Guadalajara, Jalisco 45030
    Mexico

    Site Not Available

  • Investigacion Biomedica para el Desarrollo de Fármacos S.A. de C.V.-Rheumatology

    Zapopan, Jalisco 45070
    Mexico

    Site Not Available

  • Local Institution - 0058

    Zapopan, Jalisco 45070
    Mexico

    Site Not Available

  • Eukarya PharmaSite

    Monterrey, Nuevo LEON 64718
    Mexico

    Site Not Available

  • Local Institution - 0036

    Monterrey, Nuevo LEON 64718
    Mexico

    Site Not Available

  • Local Institution - 0029

    Aguascalientes, 20130
    Mexico

    Site Not Available

  • Local Institution - 0028

    Guadalajara, 0
    Mexico

    Site Not Available

  • Local Institution - 0071

    Mexico City, 14080
    Mexico

    Site Not Available

  • Local Institution - 0086

    Bialystok, Podlaskie 15-453
    Poland

    Site Not Available

  • Local Institution - 0008

    Lodz, Łódzkie 94-046
    Poland

    Site Not Available

  • Kliniczny Szpital Wojewodzki nr 1 im. Fryderyka Chopina w Rzeszowie-Klinika Dermatologii

    Rzeszów, 35-055
    Poland

    Site Not Available

  • Local Institution - 0005

    Rzeszów, 35-055
    Poland

    Site Not Available

  • Local Institution - 0009

    Wroclaw, 50-566
    Poland

    Site Not Available

  • Local Institution

    Kemerovo, 650070
    Russian Federation

    Site Not Available

  • Local Institution

    Moscow, 119021
    Russian Federation

    Site Not Available

  • Local Institution - 0031

    Kaohsiung, 833
    Taiwan

    Site Not Available

  • Local Institution - 0021

    Taichung, 404
    Taiwan

    Site Not Available

  • Chung Shan Medical University Hospital

    Taichung City, 402
    Taiwan

    Site Not Available

  • Local Institution - 0023

    Taichung City, 402
    Taiwan

    Site Not Available

  • Local Institution - 0022

    Taipei, 10051
    Taiwan

    Site Not Available

  • Local Institution - 0077

    Scottsdale, Arizona 85259
    United States

    Site Not Available

  • Mayo Clinic in Arizona - Scottsdale

    Scottsdale, Arizona 85259
    United States

    Active - Recruiting

  • Local Institution - 0076

    Irvine, California 92697
    United States

    Site Not Available

  • University of California, Irvine

    Irvine, California 92697
    United States

    Active - Recruiting

  • Dermatology Research Associates - Los Angeles

    Los Angeles, California 90045
    United States

    Active - Recruiting

  • Local Institution - 0046

    Los Angeles, California 90045
    United States

    Site Not Available

  • Local Institution - 0073

    Farmington, Connecticut 06030
    United States

    Site Not Available

  • UConn Health

    Farmington, Connecticut 06030
    United States

    Active - Recruiting

  • Local Institution - 0082

    Orlando, Florida 32827
    United States

    Site Not Available

  • University of Central Florida College of Medicine

    Orlando, Florida 32827
    United States

    Active - Recruiting

  • Local Institution - 0083

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Local Institution - 0060

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

  • University Of Michigan

    Ann Arbor, Michigan 48109
    United States

    Active - Recruiting

  • Local Institution - 0059

    Saint Louis, Missouri 63108
    United States

    Site Not Available

  • Washington University School Of Medicine

    Saint Louis, Missouri 63108
    United States

    Active - Recruiting

  • Local Institution - 0088

    Bronx, New York 10467
    United States

    Site Not Available

  • Montefiore Medical Center

    Bronx, New York 10467
    United States

    Site Not Available

  • Icahn School of Medicine at Mount Sinai

    New York, New York 10029
    United States

    Active - Recruiting

  • Local Institution - 0037

    New York, New York 10029
    United States

    Site Not Available

  • Duke Health Center South Durham

    Durham, North Carolina 27713
    United States

    Active - Recruiting

  • Local Institution - 0065

    Durham, North Carolina 27713
    United States

    Site Not Available

  • Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Local Institution - 0084

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Local Institution

    Columbus, Ohio 43215
    United States

    Site Not Available

  • Local Institution - 0067

    Columbus, Ohio 43215
    United States

    Site Not Available

  • Ohio State University Wexner Medical Centre-Dermatology West

    Columbus, Ohio 43215
    United States

    Active - Recruiting

  • Local Institution - 0026

    Oklahoma City, Oklahoma 73104
    United States

    Site Not Available

  • Oklahoma Medical Research Foundation-ORRC

    Oklahoma City, Oklahoma 73104
    United States

    Active - Recruiting

  • Clinical Research Center of the Carolinas

    Charleston, South Carolina 29407
    United States

    Active - Recruiting

  • Local Institution - 0054

    Charleston, South Carolina 29407
    United States

    Site Not Available

  • Local Institution

    Rapid City, South Dakota 57702
    United States

    Site Not Available

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