A Study to Evaluate Efficacy and Safety of Deucravacitinib in Participants With Active Discoid and/or Subacute Cutaneous Lupus Erythematosus (DLE/SCLE)
- Conditions
- Lupus Erythematosus, DiscoidLupus Erythematosus, Subacute Cutaneous
- Interventions
- Drug: DeucravacitinibDrug: Placebo
- Registration Number
- NCT04857034
- Lead Sponsor
- Bristol-Myers Squibb
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 75
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Active Treatment: Deucravacitinib Dose 1 Deucravacitinib - Active Treatment: Deucravacitinib Dose 2 Deucravacitinib - Placebo Placebo -
- Primary Outcome Measures
Name Time Method Percentage change from baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index activity (CLASI-A) score at week 16 Week 16
- Secondary Outcome Measures
Name Time Method Percentage of participants with an improvement of ≥ 50% from baseline in the CLASI-A score (CLASI- 50) Week 16 Percentage of participants who have disease improvement as defined by a reduction in CLASI-A of ≥ 4 points from baseline Week 16 Mean change from baseline in CLASI-A score Week 16 Percentage of participants who have a Complete Response (CR) on CLASI-A defined as a score of "0" Week 16 Incidence of serious adverse events (SAEs) Up to 60 weeks Incidence of adverse events (AEs) Up to 56 weeks Incidence of clinically significant changes in clinical laboratory results: Hematology tests Up to 56 weeks Incidence of clinically significant changes in clinical laboratory results: Chemistry panel tests Up to 56 weeks Incidence of clinically significant changes in clinical laboratory results: Urinalysis Up to 56 weeks Incidence of clinically significant changes in vital signs: Body temperature Up to 56 weeks Incidence of clinically significant changes in vital signs: Respiratory rate Up to 56 weeks Incidence of clinically significant changes in vital signs: Blood pressure Up to 56 weeks Incidence of clinically significant changes in vital signs: Heart rate Up to 56 weeks Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QTcF interval Up to 56 weeks QTcF interval: Corrected QT interval using Fridericia's formula (QTcF)
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: PR interval Up to 56 weeks PR interval: The time from the onset of the P wave to the start of the QRS complex
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QRS interval Up to 56 weeks QRS interval: A combination of the Q wave, R wave and S wave, the "QRS complex" represents ventricular depolarization
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QT interval Up to 56 weeks QT interval: Measured from the beginning of the QRS complex to the end of the T wave
Trial Locations
- Locations (41)
Local Institution - 0071
🇲🇽Mexico City, Mexico
Local Institution - 0022
🇨🇳Taipei, Taiwan
Local Institution - 0059
🇺🇸Saint Louis, Missouri, United States
Local Institution - 0073
🇺🇸Farmington, Connecticut, United States
Local Institution
🇲🇽Guadalajara, Jalisco, Mexico
Local Institution - 0077
🇺🇸Scottsdale, Arizona, United States
Local Institution - 0076
🇺🇸Irvine, California, United States
Local Institution - 0067
🇺🇸Columbus, Ohio, United States
Local Institution - 0002
🇦🇺Camberwell, Victoria, Australia
Local Institution - 0005
🇵🇱Rzeszów, Poland
Local Institution - 0019
🇦🇷Buenos Aires, Argentina
Local Institution - 0006
🇩🇪Hamburg, Germany
Local Institution - 0023
🇨🇳Taichung City, Taiwan
Local Institution - 0009
🇵🇱Wroclaw, Poland
Local Institution - 0008
🇵🇱Lodz, Łódzkie, Poland
Local Institution - 0010
🇫🇷Paris, France
Local Institution - 0035
🇩🇪Berlin, Germany
Local Institution - 0072
🇩🇪Dresden, Sachsen, Germany
Local Institution - 0014
🇩🇪Erlangen, Germany
Local Institution - 0046
🇺🇸Los Angeles, California, United States
Local Institution - 0038
🇫🇷Bordeaux, France
Local Institution - 0037
🇺🇸New York, New York, United States
Local Institution - 0013
🇦🇷San Miguel De Tucuman, Tucuman, Argentina
Local Institution - 0018
🇦🇷Capital Federal, Buenos Aires, Argentina
Local Institution - 0003
🇦🇺Botany, New South Wales, Australia
Local Institution - 0078
🇦🇺Melbourne, Victoria, Australia
Local Institution - 0007
🇦🇺Clayton, Victoria, Australia
Local Institution - 0001
🇦🇺Kogarah, New South Wales, Australia
Local Institution - 0087
🇦🇺Victoria Park, Western Australia, Australia
Local Institution - 0027
🇫🇷Créteil, France
Local Institution - 0036
🇲🇽Monterrey, Nuevo LEON, Mexico
Local Institution - 0082
🇺🇸Orlando, Florida, United States
Local Institution - 0065
🇺🇸Durham, North Carolina, United States
Local Institution - 0026
🇺🇸Oklahoma City, Oklahoma, United States
Local Institution - 0060
🇺🇸Ann Arbor, Michigan, United States
Local Institution - 0058
🇲🇽Zapopan, Jalisco, Mexico
Local Institution - 0029
🇲🇽Aguascalientes, Mexico
Local Institution - 0028
🇲🇽Guadalajara, Mexico
Local Institution - 0031
🇨🇳Kaohsiung, Taiwan
Local Institution - 0021
🇨🇳Taichung, Taiwan
Local Institution - 0054
🇺🇸Charleston, South Carolina, United States