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A Study to Evaluate Efficacy and Safety of Deucravacitinib in Participants With Active Discoid and/or Subacute Cutaneous Lupus Erythematosus (DLE/SCLE)
Sponsor: Bristol-Myers Squibb
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.
Official 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)
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
74
Start Date
2021-07-12
Completion Date
2028-02-28
Last Updated
2025-09-10
Healthy Volunteers
No
Interventions
Deucravacitinib
Specified dose on specified days
Placebo
Specified dose on specified days
Locations (41)
Local Institution - 0077
Scottsdale, Arizona, United States
Local Institution - 0076
Irvine, California, United States
Local Institution - 0046
Los Angeles, California, United States
Local Institution - 0073
Farmington, Connecticut, United States
Local Institution - 0082
Orlando, Florida, United States
Local Institution - 0060
Ann Arbor, Michigan, United States
Local Institution - 0059
St Louis, Missouri, United States
Local Institution - 0037
New York, New York, United States
Local Institution - 0065
Durham, North Carolina, United States
Local Institution - 0067
Columbus, Ohio, United States
Local Institution - 0026
Oklahoma City, Oklahoma, United States
Local Institution - 0054
Charleston, South Carolina, United States
Local Institution - 0018
Capital Federal, Buenos Aires, Argentina
Local Institution - 0013
San Miguel de Tucumán, Tucumán Province, Argentina
Local Institution - 0019
Buenos Aires, Argentina
Local Institution - 0003
Botany, New South Wales, Australia
Local Institution - 0001
Kogarah, New South Wales, Australia
Local Institution - 0002
Camberwell, Victoria, Australia
Local Institution - 0007
Clayton, Victoria, Australia
Local Institution - 0078
Melbourne, Victoria, Australia
Local Institution - 0087
Victoria Park, Western Australia, Australia
Local Institution - 0038
Bordeaux, France
Local Institution - 0027
Créteil, France
Local Institution - 0010
Paris, France
Local Institution - 0072
Dresden, Saxony, Germany
Local Institution - 0035
Berlin, Germany
Local Institution - 0014
Erlangen, Germany
Local Institution - 0006
Hamburg, Germany
Local Institution
Guadalajara, Jalisco, Mexico
Local Institution - 0058
Zapopan, Jalisco, Mexico
Local Institution - 0036
Monterrey, Nuevo León, Mexico
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, Poland
Local Institution - 0031
Kaohsiung City, Taiwan
Local Institution - 0023
Taichung, Taiwan
Local Institution - 0021
Taichung, Taiwan
Local Institution - 0022
Taipei, Taiwan