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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
74
Specified dose on specified days
Specified dose on specified days
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
Percentage Change From Baseline in CLASI Activity Score at Week 16
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
Time frame: From first dose to Week 16 (approximately 16 weeks)
Percentage of Participants With an Improvement of ≥ 50% From Baseline in the CLASI-A Score (CLASI-50).
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
Time frame: From first dose to Week 16 (approximately 16 weeks)
Percentage of Participants Who Have Disease Improvement as Defined by a Reduction in CLASI-A of ≥ 4 Points From Baseline.
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
Time frame: From first dose to Week 16 (approximately 16 weeks)
Mean Change From Baseline in CLASI-A Score.
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
Time frame: From first dose to Week 16 (approximately 16 weeks)
Percentage of Participants Who Have a Complete Response (CR) on CLASI-A Defined as a Score of "0".
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".
Time frame: From first dose to Week 16 (approximately 16 weeks)
Number of Participants With Safety Related Events in the Placebo Controlled Period
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 Active Treatment Period
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 Clinically Significant Laboratory Abnormalities in the Placebo Controlled Period
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 Active Treatment Period
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 Vital Sign Abnormalities in the Placebo Controlled Period
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 Active Treatment Period
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 ECG Abnormalities in the Placebo Controlled Period
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 Active Treatment Period
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)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
...and 31 more locations