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BMS-986326 for Lupus

Recruiting in Palo Alto (17 mi)

+17 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Bristol-Myers Squibb

Disqualifiers: Severe SLE, Drug-induced lupus, Pregnancy, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that you cannot participate if you are using more than 10 mg of prednisone (a steroid) per day.

What makes the drug BMS-986326 unique for treating lupus?

BMS-986326 is unique because it targets specific immune system components, potentially offering a more precise approach to treating lupus compared to traditional treatments that are less specific and can cause more side effects. This drug is part of a new wave of therapies focusing on specific molecular targets, which may improve treatment outcomes and reduce adverse reactions.¹ ² ³ ⁴ ⁵

Research Team

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Eligibility Criteria

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.

Inclusion Criteria

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

I have been diagnosed with Lupus.

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

Exclusion Criteria

I have lupus caused by medication.

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

I am not pregnant or breastfeeding.

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Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive multiple increasing doses of BMS-986326 via intravenous (IV) infusion or subcutaneous (SC) injection

8-12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

BMS-986326 (Monoclonal Antibodies)

Trial OverviewThe 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.

Participant Groups

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

Find a Clinic Near You

Who Is Running the Clinical Trial?

Bristol-Myers Squibb

Lead Sponsor

Trials

2,731

Recruited

4,127,000+

Headquarters

New York City, USA

Known For

Oncology & Cardiovascular

Findings from Research

Belimumab was the first biological therapy approved for systemic lupus erythematosus (SLE), targeting the B cell-activating factor (BAFF), which represents a shift towards more specific treatments compared to traditional glucocorticoids and immunosuppressive drugs that have many side effects.

A phase IIb clinical trial showed that baricitinib, a drug targeting Janus kinase 1/2, significantly improved arthritis and skin symptoms in SLE patients compared to placebo, indicating its potential as an effective treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

State-of-the-art treatment of systemic lupus erythematosus.Tanaka, Y.[2021]

Targeting specific cytokines, such as B-cell activating factor and interferon-alpha, shows promise in treating systemic lupus erythematosus, with belimumab being the first biological agent potentially approved for this condition.

Current clinical trials are exploring various anticytokine therapies, which could lead to new treatment options for lupus, although some treatments, like anti-tumor necrosis factor, carry risks such as potential infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anticytokine therapy in systemic lupus erythematosus.Yoo, DH.[2011]

In a study involving 48 SLE patients and 24 healthy controls, it was found that CD226+ B cells were significantly more abundant in SLE patients, indicating a potential link between these cells and disease activity.

The presence of CD226+ B cells correlated with higher SLE Disease Activity Index scores and anti-dsDNA antibody levels, suggesting that they could serve as a useful biomarker for monitoring and managing systemic lupus erythematosus.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Increased Proportion of CD226+ B Cells Is Associated With the Disease Activity and Prognosis of Systemic Lupus Erythematosus.Nakano, M., Ayano, M., Kushimoto, K., et al.[2021]