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

Last updated: February 22, 2024
Sponsor: Bristol-Myers Squibb
Overall Status: Active - Recruiting

Phase

1

Condition

Lupus

Treatment

Placebo for BMS-986326

BMS-986326

Clinical Study ID

NCT06013995
IM034-1000
2022-503009-39
  • Ages 18-75
  • All Genders

Study 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 subcutaneous (SC) injection, in participants with different forms of lupus.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Having a diagnosis of Discoid Lupus Erythematosus (DLE), Subacute Cutaneous LupusErythematosus (SCLE), or Systemic Lupus Erythematosus (SLE).
  • Participants with DLE or SCLE must have their diagnosis at least 3 months prior toscreening and must be confirmed by biopsy (except if only the facial/head/neck regionis 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 2019EULAR/ACR Classification for SLE and have mild-moderate disease severity (based on aSLEDAI-2K score).

Exclusion

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 Design

Total Participants: 60
Treatment Group(s): 2
Primary Treatment: Placebo for BMS-986326
Phase: 1
Study Start date:
September 21, 2023
Estimated Completion Date:
November 24, 2025

Connect with a study center

  • Local Institution - 0070

    Pilar, Buenos Aires 1629
    Argentina

    Site Not Available

  • Local Institution - 0075

    Caba, Ciudad Autónoma De Buenos Aires C1430EGF
    Argentina

    Site Not Available

  • Local Institution - 0072

    Sofia, Sofia (stolitsa) 1618
    Bulgaria

    Site Not Available

  • Local Institution - 0071

    Dessau, 06847
    Germany

    Site Not Available

  • Local Institution - 0073

    Cuauhtémoc, Ciudad De México, Distrito Federal 06100
    Mexico

    Site Not Available

  • Local Institution - 0068

    Mexico City, Distrito Federal 07760
    Mexico

    Site Not Available

  • Local Institution - 0077

    Chihuahua, 31217
    Mexico

    Site Not Available

  • Local Institution - 0069

    Warszawa, Mazowieckie 02-953
    Poland

    Site Not Available

  • Local Institution - 0074

    Poznan, Wielkopolskie 61-848
    Poland

    Site Not Available

  • Local Institution - 0065

    Bucharest, București 11658
    Romania

    Site Not Available

  • Local Institution - 0064

    Cluj-Napoca, Cluj 400006
    Romania

    Site Not Available

  • Local Institution - 0045

    Cordoba, 14004
    Spain

    Site Not Available

  • TriWest Research Associates - La Mesa

    San Diego, California 92108
    United States

    Active - Recruiting

  • Clinical Research of West Florida, Inc. (Clearwater)

    Clearwater, Florida 33765
    United States

    Active - Recruiting

  • Clinical Research of West Florida

    Tampa, Florida 33606
    United States

    Active - Recruiting

  • North Georgia Rheumatology

    Lawrenceville, Georgia 30046
    United States

    Site Not Available

  • IMA Clinical Research Las Vegas

    Las Vegas, Nevada 89102
    United States

    Active - Recruiting

  • Columbia University Irving Medical Center

    New York, New York 10032
    United States

    Site Not Available

  • Altoona Center For Clinical Research

    Duncansville, Pennsylvania 16635
    United States

    Active - Recruiting

  • Allen Arthritis

    Allen, Texas 75013
    United States

    Site Not Available

  • Metroplex Clinical Research Center

    Dallas, Texas 75231
    United States

    Site Not Available

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