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NCT06013995

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

NCT ID: NCT06013995

Last Updated: 2025-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-21

Study Completion Date

2026-04-12

Brief Summary

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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.

Detailed Description

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Conditions

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Lupus

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Cohort A: BMS-986326 Dose 1 IV

Group Type EXPERIMENTAL

BMS-986326

Intervention Type DRUG

Specified dose on specified days

Placebo for BMS-986326

Intervention Type OTHER

Specified dose on specified days

Cohort B: BMS-986326 Dose 2 IV

Group Type EXPERIMENTAL

BMS-986326

Intervention Type DRUG

Specified dose on specified days

Placebo for BMS-986326

Intervention Type OTHER

Specified dose on specified days

Cohort C1: BMS-986326 Dose 3 IV

Group Type EXPERIMENTAL

BMS-986326

Intervention Type DRUG

Specified dose on specified days

Placebo for BMS-986326

Intervention Type OTHER

Specified dose on specified days

Cohort C2: BMS-986326 Dose 3 SC

Group Type EXPERIMENTAL

BMS-986326

Intervention Type DRUG

Specified dose on specified days

Placebo for BMS-986326

Intervention Type OTHER

Specified dose on specified days

Cohort D2: BMS-986326 Dose 4 SC

Group Type EXPERIMENTAL

BMS-986326

Intervention Type DRUG

Specified dose on specified days

Placebo for BMS-986326

Intervention Type OTHER

Specified dose on specified days

Cohort E2: BMS-986326 Dose 3 SC

Group Type EXPERIMENTAL

BMS-986326

Intervention Type DRUG

Specified dose on specified days

Placebo for BMS-986326

Intervention Type OTHER

Specified dose on specified days

Interventions

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BMS-986326

Specified dose on specified days

Intervention Type DRUG

Placebo for BMS-986326

Specified dose on specified days

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution - 0048

San Diego, California, United States

Site Status COMPLETED

Clinical Research of West Florida, Inc. (Clearwater)

Clearwater, Florida, United States

Site Status RECRUITING

Clinical Research of West Florida

Tampa, Florida, United States

Site Status RECRUITING

North Georgia Rheumatology

Lawrenceville, Georgia, United States

Site Status WITHDRAWN

Skin Sciences

Louisville, Kentucky, United States

Site Status RECRUITING

Local Institution - 0062

Las Vegas, Nevada, United States

Site Status COMPLETED

Columbia University Irving Medical Center

New York, New York, United States

Site Status WITHDRAWN

Local Institution - 0005

Duncansville, Pennsylvania, United States

Site Status COMPLETED

Allen Arthritis

Allen, Texas, United States

Site Status WITHDRAWN

Metroplex Clinical Research Center

Dallas, Texas, United States

Site Status WITHDRAWN

Arthritis Northwest, PLLC

Spokane, Washington, United States

Site Status RECRUITING

Hospital Universitario Austral

Pilar, Buenos Aires, Argentina

Site Status RECRUITING

Clinica Adventista Belgrano

CABA, Buenos Aires F.D., Argentina

Site Status RECRUITING

Local Institution - 0072

Sofia, , Bulgaria

Site Status ACTIVE_NOT_RECRUITING

Charité Research Organisation

Berlin, , Germany

Site Status RECRUITING

Städtisches Klinikum Dessau

Dessau, , Germany

Site Status RECRUITING

Universitaetsklinikum Carl Gustav Carus Dresden

Dresden, , Germany

Site Status RECRUITING

Local Institution - 0073

Cuauhtémoc, Ciudad de México, DIF, Mexico

Site Status WITHDRAWN

Local Institution - 0068

Mexico City, DIF, Mexico

Site Status WITHDRAWN

Local Institution - 0077

Chihuahua City, , Mexico

Site Status WITHDRAWN

Local Institution - 0051

Leiden, , Netherlands

Site Status COMPLETED

Klinika Ambroziak Dermatologia

Warsaw, Masovian Voivodeship, Poland

Site Status RECRUITING

Uniwersytecki Szpital Kliniczny w Poznaniu

Poznan, , Poland

Site Status RECRUITING

ARENSIA Exploratory Medicine

Bucharest, București, Romania

Site Status RECRUITING

ARENSIA Exploratory Medicine

Cluj-Napoca, Cluj, Romania

Site Status RECRUITING

Local Institution - 0046

A Coruña, A Coruña [La Coruña], Spain

Site Status COMPLETED

Local Institution - 0045

Córdoba, , Spain

Site Status COMPLETED

Countries

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United States Argentina Bulgaria Germany Mexico Netherlands Poland Romania Spain

Central Contacts

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BMS Study Connect Contact Center www.BMSStudyConnect.com

Role: CONTACT

Phone: 855-907-3286

Email: [email protected]

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

Role: CONTACT

Facility Contacts

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Robert Levin, Site 0055

Role: primary

John Carter, Site 0029

Role: primary

Leon Kircik, Site 0061

Role: primary

Howard Kenney, Site 0034

Role: primary

Pablo Maid, Site 0070

Role: primary

Federico Ariel, Site 0075

Role: primary

Stanislav Ignatenko, Site 0044

Role: primary

Christos Zouboulis, Site 0071

Role: primary

Susanne Abraham, Site 0047

Role: primary

Bartlomiej Kwiek, Site 0069

Role: primary

Aleksandra Danczak-Pazdrowska, Site 0074

Role: primary

Mihai Abobului, Site 0065

Role: primary

Daniela Fodor, Site 0064

Role: primary

Related Links

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https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

BMS Clinical Trial Information

https://www.bmsclinicaltrials.com/us/en/clinical-trials/NCT06013995.html

BMS Clinical Trial Patient Recruiting

Other Identifiers

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2022-503009-39

Identifier Type: OTHER

Identifier Source: secondary_id

IM034-1000

Identifier Type: -

Identifier Source: org_study_id