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 5391811, California 5332921

Status

Completed

Address

Local Institution - 0048

San Diego 5391811, California 5332921, 92108

Clearwater 4151316, Florida 4155751

Status

Recruiting

Address

Clinical Research of West Florida, Inc. (Clearwater)

Clearwater 4151316, Florida 4155751, 33765

Site Contact

Robert Levin, Site 0055

[email protected]

727-466-0078

Clinical Research of West Florida, Tampa 4174757, Florida 4155751

Status

Recruiting

Address

Clinical Research of West Florida

Tampa 4174757, Florida 4155751, 33606

Site Contact

John Carter, Site 0029

[email protected]

813-870-1292

North Georgia Rheumatology, Lawrenceville 4205196, Georgia 4197000

Status

Withdrawn

Address

North Georgia Rheumatology

Lawrenceville 4205196, Georgia 4197000, 30046

Skin Sciences, Louisville 4299276, Kentucky 6254925

Status

Recruiting

Address

Skin Sciences

Louisville 4299276, Kentucky 6254925, 40217

Site Contact

Leon Kircik, Site 0061

[email protected]

502-451-9000

Local Institution - 0062, Las Vegas 5506956, Nevada 5509151

Status

Completed

Address

Local Institution - 0062

Las Vegas 5506956, Nevada 5509151, 89102

New York 5128581, New York 5128638

Status

Withdrawn

Address

Columbia University Irving Medical Center

New York 5128581, New York 5128638, 10032

Altoona Center For Clinical Research, Duncansville 5187508, Pennsylvania 6254927

Status

Recruiting

Address

Altoona Center For Clinical Research

Duncansville 5187508, Pennsylvania 6254927, 16635

Site Contact

Alan Kivitz, Site 0005

[email protected]

814-693-0300

Allen Arthritis, Allen 4670300, Texas 4736286

Status

Withdrawn

Address

Allen Arthritis

Allen 4670300, Texas 4736286, 75013

Metroplex Clinical Research Center, Dallas 4684888, Texas 4736286

Status

Withdrawn

Address

Metroplex Clinical Research Center

Dallas 4684888, Texas 4736286, 75231

Arthritis Northwest, PLLC, Spokane 5811696, Washington 5815135

Status

Recruiting

Address

Arthritis Northwest, PLLC

Spokane 5811696, Washington 5815135, 99204

Site Contact

Howard Kenney, Site 0034

[email protected]

509-838-6500

International Sites

Hospital Universitario Austral, Pilar 3429980, Buenos Aires 3435907, Argentina

Status

Recruiting

Address

Hospital Universitario Austral

Pilar 3429980, Buenos Aires 3435907, 1629

Site Contact

Pablo Maid, Site 0070

[email protected]

0000000000

Clinica Adventista Belgrano, CABA, Buenos Aires F.D. 3433955, Argentina

Status

Recruiting

Address

Clinica Adventista Belgrano

CABA, Buenos Aires F.D. 3433955, 1430

Site Contact

Federico Ariel, Site 0075

[email protected]

+5491124691447

ARENSIA Exploratory Medicine - Sofia, Sofia 727011, Bulgaria

Status

Recruiting

Address

ARENSIA Exploratory Medicine - Sofia

Sofia 727011, , 1618

Site Contact

Denica Armencheva, Site 0072

[email protected]

+359878840531

Charité Research Organisation, Berlin 2950159, Germany

Status

Recruiting

Address

Charité Research Organisation

Berlin 2950159, , 10117

Site Contact

Stanislav Ignatenko, Site 0044

[email protected]

4930450539200

Städtisches Klinikum Dessau, Dessau 2937959, Germany

Status

Recruiting

Address

Städtisches Klinikum Dessau

Dessau 2937959, , 06847

Site Contact

Christos Zouboulis, Site 0071

[email protected]

555-555-5562

Dresden 2935022, Germany

Status

Recruiting

Address

Universitaetsklinikum Carl Gustav Carus Dresden

Dresden 2935022, , 01307

Site Contact

Susanne Abraham, Site 0047

[email protected]

+493514583401

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

Status

Withdrawn

Address

Local Institution - 0073

Cuauhtémoc, Ciudad de México, DIF, 06100

Local Institution - 0068, Mexico City 3530597, DIF, Mexico

Status

Withdrawn

Address

Local Institution - 0068

Mexico City 3530597, DIF, 07760

Local Institution - 0077, Chihuahua City 4014338, Mexico

Status

Withdrawn

Address

Local Institution - 0077

Chihuahua City 4014338, , 31217

Centre for Human Drug Research, Leiden 2751773, Netherlands

Status

Recruiting

Address

Centre for Human Drug Research

Leiden 2751773, , 2333 CL

Site Contact

Robert Rissmann, Site 0051

[email protected]

0031715246400

Klinika Ambroziak Dermatologia, Warsaw 756135, Masovian Voivodeship 858787, Poland

Status

Recruiting

Address

Klinika Ambroziak Dermatologia

Warsaw 756135, Masovian Voivodeship 858787, 02-953

Site Contact

Bartlomiej Kwiek, Site 0069

[email protected]

+48 608 307 575

Poznan 3088171, Poland

Status

Recruiting

Address

Uniwersytecki Szpital Kliniczny w Poznaniu

Poznan 3088171, , 61-848

Site Contact

Aleksandra Danczak-Pazdrowska, Site 0074

[email protected]

48 618549265

ARENSIA Exploratory Medicine, Bucharest 683506, București 683504, Romania

Status

Recruiting

Address

ARENSIA Exploratory Medicine

Bucharest 683506, București 683504, 11658

Site Contact

Mihai Abobului, Site 0065

[email protected]

0040766412427

ARENSIA Exploratory Medicine, Cluj-Napoca 681290, Cluj 681291, Romania

Status

Recruiting

Address

ARENSIA Exploratory Medicine

Cluj-Napoca 681290, Cluj 681291, 400006

Site Contact

Daniela Fodor, Site 0064

[email protected]

0040735888506

A Coruña 3119841, A Coruña [La Coruña], Spain

Status

Recruiting

Address

CHUAC-Complejo Hospitalario Universitario A Coruña

A Coruña 3119841, A Coruña [La Coruña], 15006

Site Contact

Mercedes Freire Gonzalez, Site 0046

[email protected]

+34981176076

Hospital Universitario Reina Sofia, Córdoba 2519240, Spain

Status

Recruiting

Address

Hospital Universitario Reina Sofia

Córdoba 2519240, , 14004

Site Contact

ALEJANDRO ESCUDERO, Site 0045

[email protected]

957011631