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, Netherlands, 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.

Local Institution - 0048, San Diego, California

Status

Completed

Address

Local Institution - 0048

San Diego, California, 92108

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

John Carter, Site 0029

[email protected]

813-870-1292

North Georgia Rheumatology, Lawrenceville, Georgia

Status

Withdrawn

Address

North Georgia Rheumatology

Lawrenceville, Georgia, 30046

Skin Sciences, Louisville, Kentucky

Status

Recruiting

Address

Skin Sciences

Louisville, Kentucky, 40217

Site Contact

Leon Kircik, Site 0061

[email protected]

502-451-9000

Local Institution - 0062, Las Vegas, Nevada

Status

Completed

Address

Local Institution - 0062

Las Vegas, Nevada, 89102

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]

814-693-0300

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

Arthritis Northwest, PLLC, Spokane, Washington

Status

Recruiting

Address

Arthritis Northwest, PLLC

Spokane, Washington, 99204

Site Contact

Howard Kenney, Site 0034

[email protected]

509-838-6500

International Sites

Hospital Universitario Austral, Pilar, Buenos Aires, Argentina

Status

Recruiting

Address

Hospital Universitario Austral

Pilar, Buenos Aires, 1629

Site Contact

Pablo Maid, Site 0070

[email protected]

0000000000

Clinica Adventista Belgrano, Caba, Ciudad Autónoma De Buenos Aires, Argentina

Status

Recruiting

Address

Clinica Adventista Belgrano

Caba, Ciudad Autónoma De Buenos Aires, 1430

Site Contact

Federico Ariel, Site 0075

[email protected]

+5491124691447

ARENSIA Exploratory Medicine - Sofia, Sofia, Bulgaria

Status

Recruiting

Address

ARENSIA Exploratory Medicine - Sofia

Sofia, , 1618

Site Contact

Denica Armencheva, Site 0072

[email protected]

+359878840531

Charité Research Organisation, Berlin, Germany

Status

Recruiting

Address

Charité Research Organisation

Berlin, , 10117

Site Contact

Stanislav Ignatenko, Site 0044

[email protected]

4930450539200

Städtisches Klinikum Dessau, Dessau, Germany

Status

Recruiting

Address

Städtisches Klinikum Dessau

Dessau, , 06847

Site Contact

Christos Zouboulis, Site 0071

[email protected]

555-555-5562

Dresden, Germany

Status

Recruiting

Address

Universitaetsklinikum Carl Gustav Carus Dresden

Dresden, , 01307

Site Contact

Susanne Abraham, Site 0047

[email protected]

+493514583401

Local Institution - 0073, Cuauhtémoc, Ciudad De México, DIF, Mexico

Status

Not yet recruiting

Address

Local Institution - 0073

Cuauhtémoc, Ciudad De México, DIF, 06100

Site Contact

Site 0073

[email protected]

855-907-3286

Local Institution - 0068, Mexico City, DIF, Mexico

Status

Withdrawn

Address

Local Institution - 0068

Mexico City, DIF, 07760

Local Institution - 0077, Chihuahua, Mexico

Status

Withdrawn

Address

Local Institution - 0077

Chihuahua, , 31217

Centre for Human Drug Research, Leiden, Netherlands

Status

Recruiting

Address

Centre for Human Drug Research

Leiden, , 2333 CL

Site Contact

Robert Rissmann, Site 0051

[email protected]

0031715246400

Klinika Ambroziak Dermatologia, Warszawa, Mazowieckie, Poland

Status

Recruiting

Address

Klinika Ambroziak Dermatologia

Warszawa, Mazowieckie, 02-953

Site Contact

Bartlomiej Kwiek, Site 0069

[email protected]

+48 608 307 575

Poznan, Poland

Status

Recruiting

Address

Uniwersytecki Szpital Kliniczny w Poznaniu

Poznan, , 61-848

Site Contact

Aleksandra Danczak-Pazdrowska, Site 0074

[email protected]

48 618549265

ARENSIA Exploratory Medicine, Bucharest, București, Romania

Status

Recruiting

Address

ARENSIA Exploratory Medicine

Bucharest, București, 11658

Site Contact

Mihai Abobului, Site 0065

[email protected]

0040766412427

ARENSIA Exploratory Medicine, Cluj-Napoca, Cluj, Romania

Status

Recruiting

Address

ARENSIA Exploratory Medicine

Cluj-Napoca, Cluj, 400006

Site Contact

Daniela Fodor, Site 0064

[email protected]

0040735888506

A Coruña, A Coruña [La Coruña], Spain

Status

Recruiting

Address

CHUAC-Complejo Hospitalario Universitario A Coruña

A Coruña, A Coruña [La Coruña], 15006

Site Contact

Mercedes Freire Gonzalez, Site 0046

[email protected]

+34981176076

Hospital Universitario Reina Sofia, Cordoba, Spain

Status

Recruiting

Address

Hospital Universitario Reina Sofia

Cordoba, , 14004

Site Contact

ALEJANDRO ESCUDERO, Site 0045

[email protected]

957011631