A Study to Investigate the Safety, Tolerability, Drug Levels and Drug Effects of BMS-986326 in Adult Participants With Different Forms of Lupus

Study Overview
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Brief Summary
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The purpose of this study is to evaluate safety, drug levels and drug effects on cells and organs of the body, after receiving multiple increasing doses of BMS-986326 via intravenous (IV) infusion or subcutaneous (SC) injection, in participants with different forms of lupus.

Official Title
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A Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986326 in Adult Participants With Discoid Lupus Erythematosus, Subacute Cutaneous Lupus Erythematosus, or Systemic Lupus Erythematosus

Conditions
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Lupus

Intervention / Treatment
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* Drug: BMS-986326
* Other: Placebo for BMS-986326


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Having a diagnosis of Discoid Lupus Erythematosus (DLE), Subacute Cutaneous Lupus Erythematosus (SCLE), or Systemic Lupus Erythematosus (SLE). Participants with DLE or SCLE must have their diagnosis at least 3 months prior to screening and must be confirmed by biopsy (except if only the facial/head/neck region is affected) and must have some ongoing disease activity (based CLASI-A scoring). Participants with SLE must have a diagnosis of SLE at screening based on the 2019 EULAR/ACR Classification for SLE and have mild-moderate disease severity (based on a SLEDAI-2K score). Exclusion criteria: SLE that is considered by the Investigator to be severe. Drug-induced CLE and drug-induced SLE. Women who are pregnant or breastfeeding. Current use of >10 mg prednisone (or equivalent) per day. Note: Other protocol-defined inclusion/exclusion criteria apply.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Cohort A: BMS-986326 Dose 1 IV<br> | Drug: BMS-986326<br>* Specified dose on specified days<br>Other: Placebo for BMS-986326<br>* Specified dose on specified days<br>|
| Experimental: Cohort B: BMS-986326 Dose 2 IV<br> | Drug: BMS-986326<br>* Specified dose on specified days<br>Other: Placebo for BMS-986326<br>* Specified dose on specified days<br>|
| Experimental: Cohort C1: BMS-986326 Dose 3 IV<br> | Drug: BMS-986326<br>* Specified dose on specified days<br>Other: Placebo for BMS-986326<br>* Specified dose on specified days<br>|
| Experimental: Cohort C2: BMS-986326 Dose 3 SC<br> | Drug: BMS-986326<br>* Specified dose on specified days<br>Other: Placebo for BMS-986326<br>* Specified dose on specified days<br>|
| Experimental: Cohort D1: BMS-986326 Dose 4 IV<br> | Drug: BMS-986326<br>* Specified dose on specified days<br>Other: Placebo for BMS-986326<br>* Specified dose on specified days<br>|
| Experimental: Cohort D2: BMS-986326 Dose 4 SC<br> | Drug: BMS-986326<br>* Specified dose on specified days<br>Other: Placebo for BMS-986326<br>* Specified dose on specified days<br>|
| Experimental: Cohort E1: BMS-986326 Dose 3 IV<br> | Drug: BMS-986326<br>* Specified dose on specified days<br>Other: Placebo for BMS-986326<br>* Specified dose on specified days<br>|
| Experimental: Cohort E2: BMS-986326 Dose 3 SC<br> | Drug: BMS-986326<br>* Specified dose on specified days<br>Other: Placebo for BMS-986326<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 |
| --- | --- | --- |
| Number of participants with adverse events (AEs) |  | Up to 228 days | 
| Number of participants with serious adverse events (SAEs) |  | Up to 228 days | 
| Number of participants with clinical laboratory abnormalities |  | Up to 228 days | 
| Number of participants with vital sign abnormalities |  | Up to 228 days | 
| Number of participants with electrocardiogram (ECG) abnormalities |  | Up to 228 days | 
| Number of participants with physical examination abnormalities |  | Up to 228 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum observed serum concentration (Cmax) |  | Predose and post-dose up to Day 167 | 
| Time of Cmax (Tmax) |  | Predose and post-dose up to Day 167 | 
| Area under the serum concentration-time curve from time zero to time of last quantifiable concentration (AUC [0-T]) |  | Predose and post-dose up to Day 167 | 
| Change from baseline in regulatory T cells (Treg) count to Day 144 |  | Baseline up to Day 144 | 
| Change from baseline in Treg-to-conventional t cells (Tconv) ratio |  | Baseline up to Day 144 | 
| Number of participants with anti-drug antibodies |  | Baseline up to Day 167 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pharmacokinetics, BMS-986326, Cutaneous Lupus, discoid lupus erythematosus (DLE), subacute cutaneous lupus erythematosus (SCLE), Systemic lupus erythematosus (SLE)