RECRUITING

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

Conditions

Lupus Pharmacokinetics BMS-986326 Cutaneous Lupus discoid lupus erythematosus (DLE)subacute cutaneous lupus erythematosus (SCLE)Systemic lupus erythematosus (SLE)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2023-09-21

Study Completion:2025-11-24

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06013995

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.

Ages Eligible for Study:18 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.

Inclusion Criteria

Exclusion 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.

Contacts and Locations

Study Contact

BMS Study Connect Contact Center www.BMSStudyConnect.com

CONTACT

855-907-3286

Clinical.Trials@bms.com

First line of the email MUST contain the NCT# and Site #.

CONTACT

Principal Investigator

Bristol-Myers Squibb

STUDY_DIRECTOR

Bristol-Myers Squibb

Study Locations (Sites)

TriWest Research Associates - La Mesa

San Diego, California, 92108

United States

Clinical Research of West Florida, Inc. (Clearwater)

Clearwater, Florida, 33765

United States

Clinical Research of West Florida

Tampa, Florida, 33606

United States

North Georgia Rheumatology

Lawrenceville, Georgia, 30046

United States

IMA Clinical Research Las Vegas

Las Vegas, Nevada, 89102

United States

Columbia University Irving Medical Center

New York, New York, 10032

United States

Altoona Center For Clinical Research

Duncansville, Pennsylvania, 16635

United States

Allen Arthritis

Allen, Texas, 75013

United States

Metroplex Clinical Research Center

Dallas, Texas, 75231

United States

Collaborators and Investigators

Sponsor: Bristol-Myers Squibb

Bristol-Myers Squibb, STUDY_DIRECTOR, Bristol-Myers Squibb

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-09-21

Study Completion Date2025-11-24

Study Record Updates

Study Start Date2023-09-21

Study Completion Date2025-11-24

Terms related to this study

Keywords Provided by Researchers

Pharmacokinetics
BMS-986326
Cutaneous Lupus
discoid lupus erythematosus (DLE)
subacute cutaneous lupus erythematosus (SCLE)
Systemic lupus erythematosus (SLE)

Additional Relevant MeSH Terms

Lupus