A Study to Assess the Safety and Drug Levels of BMS-986256 in Participants With Active Cutaneous Lupus Erythematosus

Study Overview
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Brief Summary
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The purpose of this study is to assess the safety and drug levels of BMS-986256 in participants with cutaneous lupus erythematosus.

Official Title
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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

Conditions
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Lupus Erythematosus, Cutaneous

Intervention / Treatment
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* Drug: BMS-986256
* Other: BMS-986256 Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BMS-986256<br> | Drug: BMS-986256<br>* Specified Dose on Specified Days<br>|
| Placebo Comparator: Placebo<br> | Other: BMS-986256 Placebo<br>* Specified Dose on Specified Days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Serious Adverse Events (SAEs) |  | Up to 24 weeks | 
| Incidence of Adverse Events (AEs) |  | Up to 20 weeks | 
| Number of laboratory test abnormalities: Hematology |  | Up to 20 weeks | 
| Number of laboratory test abnormalities: Urinalysis |  | Up to 20 weeks | 
| Number of laboratory test abnormalities: Clinical Chemistry |  | Up to 20 weeks | 
| Incidence of clinically significant changes in physical examination findings |  | Up to 20 weeks | 
| Incidence of clinically significant changes in vital signs: Body temperature |  | Up to 20 weeks | 
| Incidence of clinically significant changes in vital signs: Respiratory rate |  | Up to 20 weeks | 
| Incidence of clinically significant changes in vital signs: Blood pressure |  | Up to 20 weeks | 
| Incidence of clinically significant changes in vital signs: Heart rate |  | Up to 20 weeks | 
| Incidence of clinically significant changes in Electrocardiogram (ECG) parameters |  | Up to 20 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |