Clinical Study of B001 Injection in Subjects With Neuromyelitis Optic Spectrum Disorder (NMOSD)
NCT ID: NCT05145361
Last Updated: 2025-08-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
EARLY_PHASE1
45 participants
INTERVENTIONAL
2022-04-07
2025-12-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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B001 injection
Subjects randomized to this arm will receive B001 twice, at day 1 and day 15, up to the end of the study.
B001 injection
B001 injection 50mg/5mL Intravenous solution
Placebo
Subjects randomized to this arm will receive Placebo twice, at day 1 and day 15, up to the end of the study.
Placebo
Placebo 5mL Intravenous solution
Interventions
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B001 injection
B001 injection 50mg/5mL Intravenous solution
Placebo
Placebo 5mL Intravenous solution
Eligibility Criteria
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Inclusion Criteria
2. Clinical evidence of at least 1 documented relapse in last 12 months prior to screening
3. Expanded Disability Status Scale (EDSS) score from 0 to 7.5 inclusive at screening
4. Age 18 to 70 years, inclusive at the time of informed consent
Exclusion Criteria
2. Received immunosuppression such as azathioprine, mycophenolate mofetil, methotrexate, cyclophosphamide, tacrolimus, mitoxantrone, cyclosporine A, etc, and rug therapy, biological agents such as satralizumab, tocilizumab, eculizumab, etc, 3 months prior to the first administration.
3. Evidence of serious uncontrolled concomitant diseases that may preclude participant participation, as described; Other nervous system disease, cardiovascular disease, hematologic/hematopoiesis disease, respiratory disease, muscular disease, endocrine disease, renal/urologic disease, digestive system disease, congenital or acquired severe immunodeficiency.
4. Known active infection within 3 months prior to baseline
5. Pregnancy or lactation.
6. History of severe allergic reaction to a biologic agent
7. Evidence of chronic active hepatitis B or C
8. Evidence of active tuberculosis
9. Following laboratory abnormalities at screening\*:
1. White blood cells (WBC) \<4.0 x10\^3/microliter (μL)
2. Absolute neutrophil count (ANC)
3. Absolute lymphocyte count \<0.5 x10\^3/μL
4. Platelet count \<80 x 10\^9/ L
5. Aspartate aminotransferase (AST) or alanine aminotransferase
10. History of drug or alcohol abuse within 6 months prior to baseline
11. Receipt of any live or live attenuated vaccine within 4 weeks prior to baseline
12. Uncontrolled systemic diseases, including hypertension that cannot be effectively controlled after treatment (systolic blood pressure ≥150 mmHg and/or diastolic blood pressure ≥100 mmHg), diabetes, gastrointestinal diseases, etc.; or the investigator believes that there is anything inappropriate reasons for selection.
18 Years
ALL
No
Sponsors
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Shanghai Pharmaceuticals Holding Co., Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Fu-Dong Shi, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Tianjin Medical University General Hospital
Locations
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Beijing Tiantan Hospital Capital Medical University
Beijing, Beijing Municipality, China
First Hospital of Shanxi Medical University
Taiyuan, Shanxi, China
Tangdu hospital,fourth military medical university
Xi’an, Shanxi, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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B001-103
Identifier Type: -
Identifier Source: org_study_id
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