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

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

Recruiting
18-75 years
All
Phase 1

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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.

Eligibility

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.

Study details
    Lupus

NCT06013995

Bristol-Myers Squibb

1 November 2025

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FAQs

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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