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

Description

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.

Conditions

Lupus

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Study Overview

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Study Details

Study 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.

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

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

Condition
Lupus
Intervention / Treatment

-

Contacts and Locations

San Diego

TriWest Research Associates - La Mesa, San Diego, California, United States, 92108

Clearwater

Clinical Research of West Florida, Inc. (Clearwater), Clearwater, Florida, United States, 33765

Tampa

Clinical Research of West Florida, Tampa, Florida, United States, 33606

Lawrenceville

North Georgia Rheumatology, Lawrenceville, Georgia, United States, 30046

Las Vegas

IMA Clinical Research Las Vegas, Las Vegas, Nevada, United States, 89102

New York

Columbia University Irving Medical Center, New York, New York, United States, 10032

Duncansville

Altoona Center For Clinical Research, Duncansville, Pennsylvania, United States, 16635

Allen

Allen Arthritis, Allen, Texas, United States, 75013

Dallas

Metroplex Clinical Research Center, Dallas, Texas, United States, 75231

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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).
  • * 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.

Ages Eligible for Study

18 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Bristol-Myers Squibb,

Bristol-Myers Squibb, STUDY_DIRECTOR, Bristol-Myers Squibb

Study Record Dates

2025-11-24