What side effects are associated with this type of intervention?

Common treatments for lupus, particularly monoclonal antibodies and biologics like rituximab and belimumab, can cause side effects such as infusion reactions (fever, chills, rash), increased risk of infections, allergic reactions, nausea, fatigue, and headache. Serious but less common side effects include progressive multifocal leukoencephalopathy (PML) and other severe infections.

What prior FDA approvals exist?

The FDA has approved several biologic treatments for lupus, particularly targeting specific immune pathways. Belimumab (Benlysta) is a monoclonal antibody that inhibits B-lymphocyte stimulator (BLyS), reducing the activity of B cells, which are implicated in lupus. Another notable biologic is anifrolumab (Saphnelo), which targets the type I interferon receptor, a pathway involved in the inflammatory process of lupus. These treatments are similar to BMS-986326 in that they are biologics designed to modulate specific immune pathways to manage lupus symptoms.

What other types of research exist?

Promising novel alternatives to BMS-986326 for lupus patients in 2024 include anifrolumab, a monoclonal antibody targeting the type I interferon receptor, and belimumab, a monoclonal antibody that inhibits B-lymphocyte stimulator (BLyS). Both have shown efficacy in reducing disease activity in lupus patients and have been approved for use. Additionally, therapies targeting specific pathways such as Janus kinase (JAK) inhibitors and other biologics under investigation may offer new options for lupus management.

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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).

Must not have

Drug-induced CLE and drug-induced SLE.

Current use of >10 mg prednisone (or equivalent) per day.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Summary

This trial tests a new drug called BMS-986326 to see if it is safe and how it affects the body. The drug is given in increasing doses either through a vein or under the skin. The study focuses on people with different types of lupus to find better treatment options.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have lupus caused by medication.

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I am taking more than 10 mg of prednisone or its equivalent daily.

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I am not pregnant or breastfeeding.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

BMS-986326

2021

Completed Phase 1

~90

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for lupus, particularly biologics and monoclonal antibodies like BMS-986326, work by targeting specific pathways involved in the disease. These treatments often inhibit inflammatory cytokines, reduce the activity of B cells, or block T cell co-stimulation, thereby decreasing the immune system's attack on the body's own tissues. This targeted approach is important for lupus patients as it can lead to more effective disease control with fewer side effects compared to traditional immunosuppressive therapies.

[Neuropsychiatric Systemic Lupus Erythematosus].The 2018 pipeline of targeted therapies under clinical development for Systemic Lupus Erythematosus: a systematic review of trials.