A Phase 1b Randomized, Double-blind, Placebo-controlled Study to Assess the Safety and Pharmacokinetics of BMS-986256 in Participants With Active Cutaneous Lupus Erythematosus
Overview
- Phase
- Phase 1
- Intervention
- BMS-986256
- Conditions
- Lupus Erythematosus, Cutaneous
- Sponsor
- Bristol-Myers Squibb
- Enrollment
- 13
- Locations
- 1
- Primary Endpoint
- Incidence of Serious Adverse Events (SAEs)
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
The purpose of this study is to assess the safety and drug levels of BMS-986256 in participants with cutaneous lupus erythematosus.
Investigators
Eligibility Criteria
Inclusion Criteria
- •a) Must have one of following diagnoses: i) Meet European League Against Rheumatoid (EULAR)/American College of Rheumatology 2019 Classification Criteria for systemic lupus erythematosus (SLE) OR ii) Biopsy-proven acute cutaneous lupus erythematosus (ACLE), subacute cutaneous lupus erythematosus (SCLE), or discoid lupus erythematosus (DLE): Participants without a concurrent SLE diagnosis are eligible b) Active cutaneous lupus disease, defined as a modified Cutaneous Lupus Erythematosus Disease Area and Severity Index- Activity (mCLASI-A) score ≥ 6 c) Active cutaneous lupus skin lesion(s) amenable to biopsy
- •Women of childbearing potential (WOCBP) and men must agree to follow instructions for method(s) of contraception, if applicable
Exclusion Criteria
- •Active severe or unstable neuropsychiatric SLE
- •Active, severe Lupus Nephritis (LN)
- •Any British Isles Lupus Assessment Group (BILAG) A or B, unless within the constitutional, musculoskeletal and/or mucocutaneous domains
- •Other protocol-defined inclusion/exclusion criteria apply
Arms & Interventions
BMS-986256
Intervention: BMS-986256
Placebo
Intervention: BMS-986256 Placebo
Outcomes
Primary Outcomes
Incidence of Serious Adverse Events (SAEs)
Time Frame: Up to 24 weeks
Incidence of Adverse Events (AEs)
Time Frame: Up to 20 weeks
Number of laboratory test abnormalities: Urinalysis
Time Frame: Up to 20 weeks
Number of laboratory test abnormalities: Clinical Chemistry
Time Frame: Up to 20 weeks
Number of laboratory test abnormalities: Hematology
Time Frame: Up to 20 weeks
Incidence of clinically significant changes in physical examination findings
Time Frame: Up to 20 weeks
Incidence of clinically significant changes in vital signs: Body temperature
Time Frame: Up to 20 weeks
Incidence of clinically significant changes in vital signs: Respiratory rate
Time Frame: Up to 20 weeks
Incidence of clinically significant changes in vital signs: Blood pressure
Time Frame: Up to 20 weeks
Incidence of clinically significant changes in vital signs: Heart rate
Time Frame: Up to 20 weeks
Incidence of clinically significant changes in Electrocardiogram (ECG) parameters
Time Frame: Up to 20 weeks
Secondary Outcomes
- Maximum observed plasma concentration (Cmax) of BMS-986256(Up to 20 weeks)
- Time to maximum concentration (Tmax) of BMS-986256(Up to 20 weeks)
- Trough observed plasma concentration (Ctrough) of BMS-986256(Up to 20 weeks)
- Area under the concentration-time curve over the dosing interval (AUC (TAU)) of BMS-986256(Up to 20 weeks)
- Maximum observed plasma concentration (Cmax) of metabolite BMT-271199(Up to 20 weeks)
- Time to maximum concentration (Tmax) of metabolite BMT-271199(Up to 20 weeks)
- Trough observed plasma concentration (Ctrough) of metabolite BMT-271199(Up to 20 weeks)
- Area under the concentration-time curve over the dosing interval (AUC (TAU)) of metabolite BMT-271199(Up to 20 weeks)