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

February 22, 2024 updated by: Bristol-Myers Squibb

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: BMS Study Connect Contact Center www.BMSStudyConnect.com
  • Phone Number: 855-907-3286
  • Email: Clinical.Trials@bms.com

Study Contact Backup

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

Study Locations

  • Argentina
    • Buenos Aires
      • Pilar, Buenos Aires, Argentina, 1629
        • Not yet recruiting
        • Local Institution - 0070
        • Contact:
          • Site 0070
    • Ciudad Autónoma De Buenos Aires
      • Caba, Ciudad Autónoma De Buenos Aires, Argentina, C1430EGF
        • Not yet recruiting
        • Local Institution - 0075
        • Contact:
          • Site 0075
  • Bulgaria
    • Sofia (stolitsa)
      • Sofia, Sofia (stolitsa), Bulgaria, 1618
        • Not yet recruiting
        • Local Institution - 0072
        • Contact:
          • Site 0072
  • Germany
      • Dessau, Germany, 06847
        • Not yet recruiting
        • Local Institution - 0071
        • Contact:
          • Site 0071
  • Mexico
      • Chihuahua, Mexico, 31217
        • Not yet recruiting
        • Local Institution - 0077
        • Contact:
          • Site 0077
    • Distrito Federal
      • Cuauhtémoc, Ciudad De México, Distrito Federal, Mexico, 06100
        • Not yet recruiting
        • Local Institution - 0073
        • Contact:
          • Site 0073
      • Mexico City, Distrito Federal, Mexico, 07760
        • Not yet recruiting
        • Local Institution - 0068
        • Contact:
          • Site 0068
  • Poland
    • Mazowieckie
      • Warszawa, Mazowieckie, Poland, 02-953
        • Not yet recruiting
        • Local Institution - 0069
        • Contact:
          • Site 0069
    • Wielkopolskie
      • Poznan, Wielkopolskie, Poland, 61-848
        • Not yet recruiting
        • Local Institution - 0074
        • Contact:
          • Site 0074
  • Romania
    • București
      • Bucharest, București, Romania, 11658
        • Not yet recruiting
        • Local Institution - 0065
        • Contact:
          • Site 0065
    • Cluj
      • Cluj-Napoca, Cluj, Romania, 400006
        • Not yet recruiting
        • Local Institution - 0064
        • Contact:
          • Site 0064
  • Spain
      • Cordoba, Spain, 14004
        • Not yet recruiting
        • Local Institution - 0045
        • Contact:
          • Site 0045
  • United States
    • California
      • San Diego, California, United States, 92108
        • Recruiting
        • TriWest Research Associates - La Mesa
        • Contact:
          • Ara Dikranian, Site 0048
          • Phone Number: 619-334-4735
    • Florida
      • Clearwater, Florida, United States, 33765
        • Recruiting
        • Clinical Research of West Florida, Inc. (Clearwater)
        • Contact:
          • Robert Levin, Site 0055
          • Phone Number: 727-466-0078
      • Tampa, Florida, United States, 33606
        • Recruiting
        • Clinical Research of West Florida
        • Contact:
          • Shanmugapriya Reddy, MD, Site 0029
          • Phone Number: 813-870-1292
    • Georgia
      • Lawrenceville, Georgia, United States, 30046
        • Not yet recruiting
        • North Georgia Rheumatology
        • Contact:
          • Theresa Lawrence Ford, Site 0011
          • Phone Number: 111-111-1111
    • Nevada
      • Las Vegas, Nevada, United States, 89102
        • Recruiting
        • IMA Clinical Research Las Vegas
        • Contact:
          • Rosaly Diaz-Torruellas, Site 0062
          • Phone Number: 702-527-7401
    • New York
      • New York, New York, United States, 10032
        • Withdrawn
        • Columbia University Irving Medical Center
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
        • Recruiting
        • Altoona Center for Clinical Research
        • Contact:
          • Alan Kivitz, Site 0005
          • Phone Number: 814-934-4368
    • Texas
      • Allen, Texas, United States, 75013
        • Withdrawn
        • Allen Arthritis
      • Dallas, Texas, United States, 75231
        • Withdrawn
        • Metroplex Clinical Research Center

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort A: BMS-986326 Dose 1 IV
Drug: BMS-986326
Specified dose on specified days
Other: Placebo for BMS-986326
Specified dose on specified days
Experimental: Cohort B: BMS-986326 Dose 2 IV
Drug: BMS-986326
Specified dose on specified days
Other: Placebo for BMS-986326
Specified dose on specified days
Experimental: Cohort C1: BMS-986326 Dose 3 IV
Drug: BMS-986326
Specified dose on specified days
Other: Placebo for BMS-986326
Specified dose on specified days
Experimental: Cohort C2: BMS-986326 Dose 3 SC
Drug: BMS-986326
Specified dose on specified days
Other: Placebo for BMS-986326
Specified dose on specified days
Experimental: Cohort D1: BMS-986326 Dose 4 IV
Drug: BMS-986326
Specified dose on specified days
Other: Placebo for BMS-986326
Specified dose on specified days
Experimental: Cohort D2: BMS-986326 Dose 4 SC
Drug: BMS-986326
Specified dose on specified days
Other: Placebo for BMS-986326
Specified dose on specified days
Experimental: Cohort E1: BMS-986326 Dose 3 IV
Drug: BMS-986326
Specified dose on specified days
Other: Placebo for BMS-986326
Specified dose on specified days
Experimental: Cohort E2: BMS-986326 Dose 3 SC
Drug: BMS-986326
Specified dose on specified days
Other: Placebo for BMS-986326
Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants with adverse events (AEs)
Time Frame: Up to 228 days
Up to 228 days
Number of participants with serious adverse events (SAEs)
Time Frame: Up to 228 days
Up to 228 days
Number of participants with clinical laboratory abnormalities
Time Frame: Up to 228 days
Up to 228 days
Number of participants with vital sign abnormalities
Time Frame: Up to 228 days
Up to 228 days
Number of participants with electrocardiogram (ECG) abnormalities
Time Frame: Up to 228 days
Up to 228 days
Number of participants with physical examination abnormalities
Time Frame: Up to 228 days
Up to 228 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Maximum observed serum concentration (Cmax)
Time Frame: Predose and post-dose up to Day 167
Predose and post-dose up to Day 167
Time of Cmax (Tmax)
Time Frame: Predose and post-dose up to Day 167
Predose and post-dose up to Day 167
Area under the serum concentration-time curve from time zero to time of last quantifiable concentration (AUC [0-T])
Time Frame: Predose and post-dose up to Day 167
Predose and post-dose up to Day 167
Change from baseline in regulatory T cells (Treg) count to Day 144
Time Frame: Baseline up to Day 144
Baseline up to Day 144
Change from baseline in Treg-to-conventional t cells (Tconv) ratio
Time Frame: Baseline up to Day 144
Baseline up to Day 144
Number of participants with anti-drug antibodies
Time Frame: Baseline up to Day 167
Baseline up to Day 167

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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 Major Dates

Study Start (Actual)

September 21, 2023

Primary Completion (Estimated)

November 24, 2025

Study Completion (Estimated)

November 24, 2025

Study Registration Dates

First Submitted

August 23, 2023

First Submitted That Met QC Criteria

August 23, 2023

First Posted (Actual)

August 28, 2023

Study Record Updates

Last Update Posted (Actual)

February 23, 2024

Last Update Submitted That Met QC Criteria

February 22, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IM034-1000
  • 2022-503009-39 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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