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Status:

RECRUITING

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

Lead Sponsor:

Bristol-Myers Squibb

Conditions:

Lupus

Eligibility:

All Genders

18-75 years

Phase:

PHASE1

Brief Summary

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 ...

Eligibility Criteria

Inclusion

  • 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.

Exclusion

    Key Trial Info

    Start Date :

    September 21 2023

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    April 12 2026

    Estimated Enrollment :

    44 Patients enrolled

    Trial Details

    Trial ID

    NCT06013995

    Start Date

    September 21 2023

    End Date

    April 12 2026

    Last Update

    November 7 2025

    Active Locations (27)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 7 (27 locations)

    1

    Local Institution - 0048

    San Diego, California, United States, 92108

    2

    Clinical Research of West Florida, Inc. (Clearwater)

    Clearwater, Florida, United States, 33765

    3

    Clinical Research of West Florida

    Tampa, Florida, United States, 33606

    4

    North Georgia Rheumatology

    Lawrenceville, Georgia, United States, 30046