BMS-986326 for Lupus

Recruiting at 33 trial locations

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

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Bristol-Myers Squibb

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

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 8-12 weeks

44 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests BMS-986326, a new treatment for lupus. Researchers aim to determine the treatment's safety, how it moves through the body, and its effects on cells and organs. The trial includes different groups receiving varying doses either through an IV or injection. It suits individuals diagnosed with certain types of lupus, such as Discoid Lupus Erythematosus or Systemic Lupus Erythematosus, particularly if the condition is ongoing and not severe. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

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.

Is there any evidence suggesting that BMS-986326 is likely to be safe for humans?

Research has shown that BMS-986326 is being tested for safety in people with different types of lupus. Current data from earlier studies indicate that BMS-986326 is generally well-tolerated, with participants reporting only mild side effects. These studies mainly examined how the drug works in the body and its effects on cells and organs.

Since this trial is in an early phase, it focuses on understanding the safety of BMS-986326. At this stage, researchers aim to ensure that the drug doesn't cause serious problems at different doses. While specific details on side effects aren't fully available yet, initial tests suggest the drug is expected to have manageable side effects.

Prospective participants should know that researchers are closely monitoring for any adverse effects. They aim to ensure that BMS-986326 is safe for future use in treating lupus. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for lupus?

BMS-986326 is unique because it targets lupus in a potentially new and effective way. Unlike standard treatments like corticosteroids or immunosuppressants, which can have broad effects on the immune system, BMS-986326 might offer a more targeted approach. This drug is available in both intravenous (IV) and subcutaneous (SC) forms, providing flexibility in how it can be administered. Researchers are excited because this could mean fewer side effects and more personalized treatment options for lupus patients, which is a significant step forward in managing this complex condition.

What evidence suggests that BMS-986326 might be an effective treatment for lupus?

Research shows that BMS-986326 is a new treatment targeting specific immune responses involved in lupus. It combines two proteins, IL-2 and CD25, which may help control the immune system and reduce inflammation. Early lab studies have shown promising effects in blood samples from both healthy individuals and lupus patients. These findings suggest that BMS-986326 could help manage lupus symptoms by calming the overactive immune system. While researchers continue to collect data from human trials, these early results offer hope that the treatment might be effective for people with lupus. Participants in this trial will receive different doses of BMS-986326 to evaluate its effectiveness and safety. ^{1 2 4 6 7}

Who Is on the Research Team?

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• BMS-986326

Trial Overview 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.

How Is the Trial Designed?

Group I: Cohort E2: BMS-986326 Dose 3 SC Experimental Treatment 2 Interventions

Group II: Cohort D2: BMS-986326 Dose 4 SC Experimental Treatment 2 Interventions

Group III: Cohort C2: BMS-986326 Dose 3 SC Experimental Treatment 2 Interventions

Group IV: Cohort C1: BMS-986326 Dose 3 IV Experimental Treatment 2 Interventions

Group V: Cohort B: BMS-986326 Dose 2 IV Experimental Treatment 2 Interventions

Group VI: Cohort A: BMS-986326 Dose 1 IV Experimental Treatment 2 Interventions

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

Top Products

Eliquis, Opdivo, Revlimid, Orencia

Christopher Boerner

Bristol-Myers Squibb

Chief Executive Officer since 2023

PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania

Published Research Related to This Trial

Blisibimod is a highly potent inhibitor of B cell activating factor (BAFF) and is currently being evaluated for its efficacy and safety in treating systemic lupus erythematosus (SLE) in clinical trials, including the ongoing phase 3 CHABLIS-SC1 trial.

The unique tetravalent 'peptibody' structure of blisibimod may enhance its effectiveness, and its targeted approach towards specific 'responder populations' suggests it could become a significant treatment option for both SLE and IgA nephropathy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blisibimod for treatment of systemic lupus erythematosus: with trials you become wiser. Scheinberg, MA., Hislop, CM., Martin, RS.[2018]

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]

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]

Mycophenolate mofetil (Cellcept) has been shown to be effective for both induction and maintenance therapy in lupus proliferative glomerulonephritis, with fewer adverse events compared to traditional treatments like monthly intravenous cyclophosphamide.

Rituximab (Rituxan) is a promising biologic therapy for severe systemic lupus erythematosus, targeting B-cells, although its use is currently limited and requires further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Novel approaches to therapy for systemic lupus erythematosus: update 2005. Zandman-Goddard, G., Orbach, H., Shoenfeld, Y.[2010]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06013995

NCT06013995 | A Study to Investigate the Safety, ... 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 ...

2. s3.eu-central-1.amazonaws.com s3.eu-central-1.amazonaws.com/m-anage.com.storage.eadv/abstracts_congress2023/35312.pdf

Abstract N°: 2585 BMS-986326 is a novel IL-2/CD25 fusion ... We report results from an in vitro study of BMS-. 986326 in whole blood from healthy volunteers (HVs) compared with patients with immune- ...

3. bms.com bms.com/assets/bms/us/en-us/pdf/investor-info/doc_presentations/2025/BMY-2025-Q2-Results-Investor-Presentation-with-Appendix.pdf

Q2 2025 Results Presentation BMS-986326 (IL-2-CD25), BMS-986498 (IL-10) and BMS-986481 (IL-18). 1 ... Active Systemic Lupus Erythematosus (SLE) including Lupus Nephritis (LN).

4. pharmaceutical-technology.com pharmaceutical-technology.com/data-insights/il2-cd25-bristol-myers-squibb-systemic-lupus-erythematosus-likelihood-of-approval/

IL2-CD25 by Bristol-Myers Squibb for Systemic Lupus ... BMS-986326 (IL-2/CD25) is under development for the treatment of autoimmune disorders, chronic cutaneous lupus erythematosus (CCLE) / discoid ...

5. withpower.com withpower.com/trial/phase-1-lupus-8-2023-34dbd

BMS-986326 for Lupus This trial is for adults with different forms of lupus: Discoid Lupus Erythematosus, Subacute Cutaneous Lupus Erythematosus, or Systemic Lupus Erythematosus.

6. bmsstudyconnect.com bmsstudyconnect.com/es/en/clinical-trials/NCT06013995.html

A Study to Investigate the Safety, Tolerability, Drug Levels and ... A study to investigate the safety, tolerability, drug levels and drug effects of BMS-986326 in adult participants with different forms of lupus.

7. bmsclinicaltrials.com bmsclinicaltrials.com/us/en/clinical-trials/NCT06013995

Trial ID IM034-1000 | NCT06013995 - BMS Clinical Trials A Study to Investigate the Safety, Tolerability, Drug Levels and Drug Effects of BMS-986326 in Adult Participants With Different Forms of Lupus. About This ...