Actively Recruiting
Clinical Study of B001 Injection in Subjects With Neuromyelitis Optic Spectrum Disorder (NMOSD)
Led by Shanghai Pharmaceuticals Holding Co., Ltd · Updated on 2026-05-05
45
Participants Needed
4
Research Sites
244 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The objectives of this phase Ib study are to evaluate the efficacy, safety, pharmacokinetics, pharmacodynamics and immunogenic profiles of B001 in subjects with aquaporin-4 antibody (AQP4-IgG) positive NMOSD.
CONDITIONS
Official Title
Clinical Study of B001 Injection in Subjects With Neuromyelitis Optic Spectrum Disorder (NMOSD)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 70 years at the time of informed consent
- Diagnosis of NMOSD with positive anti-AQP4 antibody at screening according to 2015 criteria
- At least one documented NMOSD relapse in the 12 months before screening
- Expanded Disability Status Scale (EDSS) score from 0 to 7.5 inclusive at screening
You will not qualify if you...
- Treatment with anti-CD20, eculizumab, anti-BLyS monoclonal antibody, or other MS relapse prevention treatments within 6 months before baseline
- Immunosuppressive therapy or biological agents within 3 months before the first administration
- Serious uncontrolled diseases including nervous system, cardiovascular, hematologic, respiratory, muscular, endocrine, renal, digestive diseases, or severe immunodeficiency
- Active infection within 3 months before baseline
- Pregnancy or lactation
- History of severe allergic reaction to biologic agents
- Chronic active hepatitis B or C
- Active tuberculosis
- Laboratory abnormalities at screening such as low white blood cells, neutrophils, lymphocytes, platelets, or elevated liver enzymes
- History of drug or alcohol abuse within 6 months before baseline
- Receipt of live or live attenuated vaccine within 4 weeks before baseline
- Uncontrolled systemic diseases, including hypertension not controlled by treatment, diabetes, or gastrointestinal diseases, or other concerns by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Beijing Tiantan Hospital Capital Medical University
Beijing, Beijing Municipality, China, 100050
Actively Recruiting
2
First Hospital of Shanxi Medical University
Taiyuan, Shanxi, China, 030001
Actively Recruiting
3
Tangdu hospital,fourth military medical university
Xi’an, Shanxi, China, 710038
Actively Recruiting
4
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China, 300052
Actively Recruiting
Research Team
F
Fu-Dong Shi, MD,PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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