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Monoclonal Antibodies

BMS-986326 for Lupus

Phase 1

Recruiting

Research Sponsored by Bristol-Myers Squibb

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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).

Having a diagnosis of Discoid Lupus Erythematosus (DLE), Subacute Cutaneous Lupus Erythematosus (SCLE), or Systemic Lupus Erythematosus (SLE).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 228 days

Awards & highlights

Study Summary

This trial tests the safety, levels, and effects of BMS-986326, given via IV or SC, for different types of lupus.

Who is the study for?

This trial is for adults with different forms of lupus: Discoid Lupus Erythematosus, Subacute Cutaneous Lupus Erythematosus, or Systemic Lupus Erythematosus. Participants must have an official diagnosis and some ongoing disease activity. Pregnant or breastfeeding women, those on high doses of steroids, or with severe SLE are excluded.Check my eligibility

What is being tested?

The study tests BMS-986326's safety and effects on the body in lupus patients. It involves multiple increasing doses administered through IV infusion or SC injection compared to a placebo to see how well it works and what changes it causes in cells and organs.See study design

What are the potential side effects?

While specific side effects aren't listed here, participants may experience reactions related to the drug's impact on their immune system since BMS-986326 targets lupus symptoms by modifying immune responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with mild to moderate SLE according to the 2019 criteria.

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I have been diagnosed with Lupus.

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I was diagnosed with DLE or SCLE over 3 months ago, confirmed by biopsy, and still have active symptoms.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 228 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 228 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 228 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of participants with adverse events (AEs)

Number of participants with clinical laboratory abnormalities

Number of participants with electrocardiogram (ECG) abnormalities

+3 more

Secondary outcome measures

Area under the serum concentration-time curve from time zero to time of last quantifiable concentration (AUC [0-T])

Change from baseline in Treg-to-conventional t cells (Tconv) ratio

Change from baseline in regulatory T cells (Treg) count to Day 144

+3 more

Trial Design

8Treatment groups

Experimental Treatment

Group I: Cohort E2: BMS-986326 Dose 3 SCExperimental Treatment2 Interventions

Group II: Cohort E1: BMS-986326 Dose 3 IVExperimental Treatment2 Interventions

Group III: Cohort D2: BMS-986326 Dose 4 SCExperimental Treatment2 Interventions

Group IV: Cohort D1: BMS-986326 Dose 4 IVExperimental Treatment2 Interventions

Group V: Cohort C2: BMS-986326 Dose 3 SCExperimental Treatment2 Interventions

Group VI: Cohort C1: BMS-986326 Dose 3 IVExperimental Treatment2 Interventions

Group VII: Cohort B: BMS-986326 Dose 2 IVExperimental Treatment2 Interventions

Group VIII: Cohort A: BMS-986326 Dose 1 IVExperimental Treatment2 Interventions

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor

2,641 Previous Clinical Trials

4,130,004 Total Patients Enrolled

4 Trials studying Lupus

1,051 Patients Enrolled for Lupus

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this experimental research open to adults aged 20 and up?

"This clinical investigation abides by the regulation that candidates need to be between 18 and 75 years of age in order to participate."

Answered by AI

How secure is the application of BMS-986326 Dose 1 IV in Cohort A?

"According to our internal assessment, Cohort A: BMS-986326 Dose 1 IV has limited evidence backing its safety and efficacy. Therefore, it was given a score of 1 on the scale from 1 to 3."

Answered by AI

Is it possible to become a participant of this clinical experiment?

"This trial, which has a recruitment goal of 60 patients, is limited to those suffering from lupus and who are aged between 18 and 75."

Answered by AI

Where are the participating sites for this clinical trial?

"The current trial is being conducted in numerous locations, including North Georgia Rheumatology in Lawrenceville (GA), IMA Clinical Research Las Vegas (NV), and Allen Arthritis located in Allen (TX). A total of 11 sites are participating."

Answered by AI

Is enrollment for this trial currently available to participants?

"The information listed on clinicaltrials.gov indicates that this trial has ceased recruiting participants, with the first posting taking place in September 15th, 2023 and its most recent update occurring August 23rd of the same year. Despite this study no longer seeking candidates there are 6 other trials searching for patients currently."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "A Study to Investigate the Safety, Tolerability, Drug Levels and Drug Effects of BMS-986326 in Adult Participants With Different Forms of Lupus". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06013995.

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