BMS-986353 for Neuromyelitis Optica Spectrum Disorder

MH
Overseen ByManuel Huichapa
Age: 18 - 65
Sex: Any
Trial Phase: Phase 1
Sponsor: University of Texas Southwestern Medical Center
Must be taking: Ravulizumab, Satralizumab
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called BMS-986353 (also known as CC-97540) for individuals with neuromyelitis optica spectrum disorder (NMOSD), a rare autoimmune condition. The researchers aim to determine if this treatment is safe and can reduce disease activity by targeting specific antibodies linked to NMOSD. Participants must have NMOSD with anti-AQP4 antibodies, remain stable on their current treatment, and not have experienced a relapse in the past year. The study involves taking BMS-986353 alongside current NMOSD therapy, with regular check-ups to monitor safety and potential benefits. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.

Do I have to stop taking my current medications?

No, you can continue your current NMOSD therapy while participating in the trial.

Is there any evidence suggesting that BMS-986353 is likely to be safe for humans?

A previous study found BMS-986353 to be safe and well-tolerated in adults with neuromyelitis optica spectrum disorder (NMOSD) who have antibodies against AQP4. Most participants did not experience serious side effects that required stopping treatment. The study examined responses to various doses of the drug, and the results were positive regarding safety. Although further research is necessary, these early findings suggest that BMS-986353 could be a promising option for those with NMOSD.12345

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for Neuromyelitis Optica Spectrum Disorder (NMOSD), which often include immunosuppressive therapies like rituximab or eculizumab, BMS-986353 stands out because it targets the condition in a novel way. This experimental drug is designed specifically for patients who are AQP4 antibody-positive, offering a more tailored approach. Researchers are excited about BMS-986353 because it may provide a more effective treatment by directly addressing the underlying biological mechanisms of NMOSD, potentially leading to better outcomes for patients with fewer side effects.

What evidence suggests that BMS-986353 might be an effective treatment for NMOSD?

Research has shown that BMS-986353, also known as CC-97540, is under investigation as a potential treatment for neuromyelitis optica spectrum disorder (NMOSD). This disorder often involves harmful antibodies that mistakenly attack the body, specifically targeting AQP4. Current treatments reduce flare-ups but do not eliminate these antibodies. BMS-986353 aims to target and eliminate the cells producing these antibodies, potentially lowering disease activity. Early studies on similar treatments have been promising, with some patients showing symptom improvement. However, researchers are still gathering clear evidence of BMS-986353's effectiveness in humans. Participants in this trial who are AQP4 antibody-positive NMOSD will receive BMS-986353 to further evaluate its potential benefits.12367

Who Is on the Research Team?

BG

Benjamin Greenberg, MD

Principal Investigator

UT Southwestern

Are You a Good Fit for This Trial?

This trial is for adults aged 18–60 with neuromyelitis optica spectrum disorder (NMOSD) who test positive for AQP4 antibodies, are stable on ravulizumab or satralizumab for at least 6 months, have not had a relapse in the past year, and meet certain vision and mobility requirements.

Inclusion Criteria

I am between 18 and 60 years old.
I have been on a stable dose of ravulizumab or satralizumab for 6 months.
I have NMOSD and tested positive for anti-AQP4 antibodies.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive CC-97540 (BMS-986353) and continue their current NMOSD therapy

52 weeks
Regular visits for safety checks, exams, and lab tests

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Long-term follow-up

Participants are assessed for relapse-free status and sero-reversion

12 months

What Are the Treatments Tested in This Trial?

Interventions

  • CC-97540 (BMS-986353)

Trial Overview

The study tests if CC-97540 (BMS-986353), given alongside current NMOSD treatment, is safe and well tolerated. It also looks to see if this new drug can reduce harmful antibodies linked to NMOSD. Participants continue their usual therapy while receiving the study drug.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Participants who are AQP4 antibody-positive NMOSD treated with CC-97540 (BMS- 986353)Experimental Treatment4 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials
1,102
Recruited
1,077,000+

Bristol-Myers Squibb

Industry 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 profile image

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 profile image

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

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

Citations

A Safety and Tolerability Study of CC- 97540 (BMS-086353 ...

Approved NMOSD treatments reduce relapses by changing how the immune system works, but they do not remove the cells that make AQP4 antibodies.

BMS-986353 for Neuromyelitis Optica Spectrum Disorder

The goal of this clinical trial is to find out if the investigational medicine BMS-986353 is safe and well tolerated in adults with ...

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/41925501/

Neuromyelitis Optica Spectrum Disorder

Objective: This article reviews the clinical features of and diagnostic and treatment approaches to neuromyelitis optica spectrum disorder ...

zolacaptagene autoleucel (BMS-986353) / BMS

Safety and efficacy of CD19 NEX-T® (BMS-986353)—a CD19-directed chimeric antigen receptor (CAR) T cell therapy—for severe refractory systemic lupus ...

Real-World Efficacy and Safety of Neuromyelitis Optica ... - PMC

Neuromyelitis optica spectrum disorder (NMOSD) is characterized by inflammatory relapses that result in severe disability, including blindness and paralysis.

Neuromyelitis Optica Spectrum Disorder Clinical Trials

This drug is approved by the US Food and Drug Administration (FDA) for treating adults with anti-AQP4 antibody-positive NMOSD, based on 2 ...

About Neuromyelitis Optica Spectrum Disorder (NMOSD)

Safety and efficacy of satralizumab monotherapy in neuromyelitis optica spectrum disorder: a randomised, double-blind, multicentre, placebo-controlled phase ...