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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06013995
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Bristol-Myers Squibb
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Bristol-Myers Squibb
Principal Investigator Affiliation Bristol-Myers Squibb
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Argentina, Bulgaria, Germany, Mexico, Poland, Romania, Spain, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Lupus
Study Website: View Trial Website
Arms & Interventions

Arms

Experimental: Cohort A: BMS-986326 Dose 1 IV

Experimental: Cohort B: BMS-986326 Dose 2 IV

Experimental: Cohort C1: BMS-986326 Dose 3 IV

Experimental: Cohort C2: BMS-986326 Dose 3 SC

Experimental: Cohort D1: BMS-986326 Dose 4 IV

Experimental: Cohort D2: BMS-986326 Dose 4 SC

Experimental: Cohort E1: BMS-986326 Dose 3 IV

Experimental: Cohort E2: BMS-986326 Dose 3 SC

Interventions

Drug: - BMS-986326

Specified dose on specified days

Other: - Placebo for BMS-986326

Specified dose on specified days

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

TriWest Research Associates - La Mesa, San Diego, California

Status

Recruiting

Address

TriWest Research Associates - La Mesa

San Diego, California, 92108

Site Contact

Ara Dikranian, Site 0048

[email protected]

619-334-4735

Clearwater, Florida

Status

Recruiting

Address

Clinical Research of West Florida, Inc. (Clearwater)

Clearwater, Florida, 33765

Site Contact

Robert Levin, Site 0055

[email protected]

727-466-0078

Clinical Research of West Florida, Tampa, Florida

Status

Recruiting

Address

Clinical Research of West Florida

Tampa, Florida, 33606

Site Contact

Shanmugapriya Reddy, MD, Site 0029

[email protected]

813-870-1292

North Georgia Rheumatology, Lawrenceville, Georgia

Status

Not yet recruiting

Address

North Georgia Rheumatology

Lawrenceville, Georgia, 30046

Site Contact

Theresa Lawrence Ford, Site 0011

[email protected]

111-111-1111

IMA Clinical Research Las Vegas, Las Vegas, Nevada

Status

Recruiting

Address

IMA Clinical Research Las Vegas

Las Vegas, Nevada, 89102

Site Contact

Rosaly Diaz-Torruellas, Site 0062

[email protected]

702-527-7401

New York, New York

Status

Withdrawn

Address

Columbia University Irving Medical Center

New York, New York, 10032

Altoona Center For Clinical Research, Duncansville, Pennsylvania

Status

Recruiting

Address

Altoona Center For Clinical Research

Duncansville, Pennsylvania, 16635

Site Contact

Alan Kivitz, Site 0005

[email protected]

814-934-4368

Allen Arthritis, Allen, Texas

Status

Withdrawn

Address

Allen Arthritis

Allen, Texas, 75013

Metroplex Clinical Research Center, Dallas, Texas

Status

Withdrawn

Address

Metroplex Clinical Research Center

Dallas, Texas, 75231

International Sites

Local Institution - 0070, Pilar, Buenos Aires, Argentina

Status

Not yet recruiting

Address

Local Institution - 0070

Pilar, Buenos Aires, 1629

Site Contact

Site 0070

[email protected]

855-907-3286

Local Institution - 0075, Caba, Ciudad Autónoma De Buenos Aires, Argentina

Status

Not yet recruiting

Address

Local Institution - 0075

Caba, Ciudad Autónoma De Buenos Aires, C1430EGF

Site Contact

Site 0075

[email protected]

855-907-3286

Local Institution - 0072, Sofia, Sofia (stolitsa), Bulgaria

Status

Not yet recruiting

Address

Local Institution - 0072

Sofia, Sofia (stolitsa), 1618

Site Contact

Site 0072

[email protected]

855-907-3286

Local Institution - 0071, Dessau, Germany

Status

Not yet recruiting

Address

Local Institution - 0071

Dessau, , 06847

Site Contact

Site 0071

[email protected]

855-907-3286

Local Institution - 0073, Cuauhtémoc, Ciudad De México, Distrito Federal, Mexico

Status

Not yet recruiting

Address

Local Institution - 0073

Cuauhtémoc, Ciudad De México, Distrito Federal, 06100

Site Contact

Site 0073

[email protected]

855-907-3286

Local Institution - 0068, Mexico City, Distrito Federal, Mexico

Status

Not yet recruiting

Address

Local Institution - 0068

Mexico City, Distrito Federal, 07760

Site Contact

Site 0068

[email protected]

855-907-3286

Local Institution - 0077, Chihuahua, Mexico

Status

Not yet recruiting

Address

Local Institution - 0077

Chihuahua, , 31217

Site Contact

Site 0077

[email protected]

855-907-3286

Local Institution - 0069, Warszawa, Mazowieckie, Poland

Status

Not yet recruiting

Address

Local Institution - 0069

Warszawa, Mazowieckie, 02-953

Site Contact

Site 0069

[email protected]

855-907-3286

Local Institution - 0074, Poznan, Wielkopolskie, Poland

Status

Not yet recruiting

Address

Local Institution - 0074

Poznan, Wielkopolskie, 61-848

Site Contact

Site 0074

[email protected]

855-907-3286

Local Institution - 0065, Bucharest, București, Romania

Status

Not yet recruiting

Address

Local Institution - 0065

Bucharest, București, 11658

Site Contact

Site 0065

[email protected]

855-907-3286

Local Institution - 0064, Cluj-Napoca, Cluj, Romania

Status

Not yet recruiting

Address

Local Institution - 0064

Cluj-Napoca, Cluj, 400006

Site Contact

Site 0064

[email protected]

855-907-3286

Local Institution - 0045, Cordoba, Spain

Status

Not yet recruiting

Address

Local Institution - 0045

Cordoba, , 14004

Site Contact

Site 0045

[email protected]

855-907-3286