Actively Recruiting
A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of B001 Injection in Aquaporin-4 Antibody Positive Patients With Neuromyelitis Optica Spectrum Disorder
Led by Shanghai Jiaolian Drug Research and Development Co., Ltd · Updated on 2026-05-05
132
Participants Needed
51
Research Sites
69 weeks
Total Duration
On this page
Sponsors
S
Shanghai Jiaolian Drug Research and Development Co., Ltd
Lead Sponsor
S
Shanghai Pharmaceuticals Holding Co., Ltd
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of B001 injection in patients who have neuromyelitis optica spectrum disorder NMOSD and test positive for aquaporin-4 antibodies. This condition involves recurrent attacks affecting the nervous system. The study is a multicenter, randomized, double-blind, placebo-controlled trial conducted in phases II and III to understand how well B001 works and how safe it is for these patients. Participants will receive intravenous doses of either B001 or a placebo on Day 1 and Day 15 during the randomized controlled period. The study includes two groups one receiving B001 injections and the other receiving placebo injections matching B001s schedule. The trial will extend over several years, monitoring patients closely for disease relapse and treatment side effects. During the study, participants will be regularly assessed for the time to their first NMOSD attack, changes in disability status, vision acuity, and opticospinal function. Researchers will also observe the annual relapse rate and document any adverse events. The trial includes safety monitoring for about three years to ensure comprehensive data collection on treatment impact and participant health.
CONDITIONS
Brief Title
A Clinical Study of B001 Injection in the Treatment of Neuromyelitis Optica Spectrum Disorders(NMOSD)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of neuromyelitis optica spectrum disorder (NMOSD)
- Experienced at least 1 NMOSD relapse within the past year or at least 2 relapses within the past 2 years prior to screening
- Negative blood pregnancy test within 7 days before first dose for fertile females
- Willing to use reliable contraception during the study and for 6 months after stopping the study drug if fertile
- Voluntary participation with signed informed consent and ability to complete all study procedures
You will not qualify if you...
- Severe NMOSD judged unfit for study participation
- Chronic active immune diseases under systemic treatment
- Received anti-CD20 or other cell depletion therapy within 6 months before first dose
- Taken prescribed drug treatment shortly before first dose
- Participation in any drug clinical trial within 28 days before first dose
- Previous hematopoietic stem cell transplantation or lymphatic irradiation before first dose
- Pregnant or breastfeeding women or planning pregnancy during the trial
- Major surgery within 2 months before screening or planned during the trial
- Severe, progressive, or uncontrolled diseases increasing study risk
- History of gastrointestinal perforation or fistula within 6 months before screening
- Live or attenuated vaccine within 4 weeks before first dose or planned vaccination during study
- Severe or persistent infection currently or within 1 month before screening
- Positive gamma interferon release test
- Active hepatitis or history of severe liver disease
- Uncontrolled systemic disease or other investigator concerns
- Abnormal laboratory test results
- History of alcohol or drug abuse within 6 months before screening
- Severe mental illness with clinical uncooperativeness
- Unable to undergo magnetic resonance imaging or other investigator concerns
Research Team
F
FuDong Shi
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