BMS-986353 for Neuromyelitis Optica Spectrum Disorder
What You Need to Know Before You Apply
What is the purpose of this trial?
The goal of this clinical trial is to find out if the investigational medicine BMS-986353 is safe and well tolerated in adults with anti-aquaporin-4 (AQP4) antibody-positive neuromyelitis optica spectrum disorder (NMOSD). NMOSD is a long-term autoimmune condition that affects the optic nerves and spinal cord and can lead to relapses. Most people with NMOSD have antibodies against AQP4, which are linked to future disease activity.
The main questions this study aims to answer are:
"-" Is CC-97540 (BMS-986353) safe and well tolerated, based on how many participants experience serious side effects that limit dosing (called dose-limiting toxicities)?
"-" Does CC-97540 (BMS-986353) show early signs of benefit, based on how many participants no longer have detectable AQP4 antibodies in their blood (called sero-reversion)?
Participants are adults aged 18 to 60 years with AQP4 antibody-positive NMOSD who are currently clinically stable on ravulizumab or satralizumab. Approved NMOSD treatments reduce relapses by changing how the immune system works, but they do not remove the cells that make AQP4 antibodies. This study is designed to see whether BMS-986353 can target these cells without the need for long-term immune suppression.
Participants will:
"-" Receive CC-97540 (BMS-986353) as part of the study "-" Continue their current NMOSD therapy "-" Attend study visits for safety checks, exams, and lab tests
Who Is on the Research Team?
Benjamin Greenberg, MD
Principal Investigator
UT Southwestern
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive CC-97540 (BMS-986353) and continue their current NMOSD therapy
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term follow-up
Participants are assessed for relapse-free status and sero-reversion
What Are the Treatments Tested in This Trial?
Interventions
- CC-97540 (BMS-986353)
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Texas Southwestern Medical Center
Lead Sponsor
Bristol-Myers Squibb
Industry Sponsor
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
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.