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Trial ID IM034-1000  |   NCT06013995

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

Summary

  • Phase 1
  • Male and Female Gender icon
  • 18-75
    Age Range
  • 15
    Locations
  • BMS Recruiting Study icon
    Recruiting

Overview

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.

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Key Eligibility Criteria

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.

Treatment Options

Study Arms

ASSIGNED INTERVENTION

Study Arms

Experimental: Cohort A: BMS-986326 Dose 1 IV

ASSIGNED INTERVENTION
  • Drug: BMS-986326
  • Other: Placebo for BMS-986326

Study Arms

Experimental: Cohort B: BMS-986326 Dose 2 IV

ASSIGNED INTERVENTION
  • Drug: BMS-986326
  • Other: Placebo for BMS-986326

Study Arms

Experimental: Cohort C1: BMS-986326 Dose 3 IV

ASSIGNED INTERVENTION
  • Drug: BMS-986326
  • Other: Placebo for BMS-986326

Study Arms

Experimental: Cohort C2: BMS-986326 Dose 3 SC

ASSIGNED INTERVENTION
  • Drug: BMS-986326
  • Other: Placebo for BMS-986326

Study Arms

Experimental: Cohort D1: BMS-986326 Dose 4 IV

ASSIGNED INTERVENTION
  • Drug: BMS-986326
  • Other: Placebo for BMS-986326

Study Arms

Experimental: Cohort D2: BMS-986326 Dose 4 SC

ASSIGNED INTERVENTION
  • Drug: BMS-986326
  • Other: Placebo for BMS-986326

Study Arms

Experimental: Cohort E1: BMS-986326 Dose 3 IV

ASSIGNED INTERVENTION
  • Drug: BMS-986326
  • Other: Placebo for BMS-986326

Study Arms

Experimental: Cohort E2: BMS-986326 Dose 3 SC

ASSIGNED INTERVENTION
  • Drug: BMS-986326
  • Other: Placebo for BMS-986326
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