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Clinical Trials in China / NCT05145361
Recruiting Phase EARLY_PHASE1

Clinical Study of B001 Injection in Subjects With Neuromyelitis Optic Spectrum Disorder (NMOSD)

NCT05145361 · tracked via the Priya Life Science China tracker
Sponsor
Shanghai Pharmaceuticals Holding Co., Ltd
Phase
Phase EARLY_PHASE1
Started
2022-04-07
Last updated
2026-05-05

Condition(s) studied

NMO Spectrum Disorder

Investigational drug(s) / intervention(s)

B001 injectionPlacebo

B001 injection: B001 injection 50mg/5mL Intravenous solution

Placebo: Placebo 5mL Intravenous solution

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: 1. NMOSD as defined by either of the following 2015 criteria with anti-AQP4 antibody (Ab) seropositive status at screening 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: 1. Any previous treatment with anti-CD20, eculizumab, anti-BLyS monoclonal antibody (e.g., belimumab), any other treatment for prevention of multiple sclerosis (MS) relapse (e.g., interferon, natalizumab, glatiramer acetate, fingolimod, teriflunomide or dimethyl fumarate) within 6 months prior to baseline. 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.

Primary outcome measure(s)

Trial sites (4)

FacilityCityRegionStatus
Beijing Tiantan Hospital Capital Medical University Beijing Beijing Municipality Recruiting
First Hospital of Shanxi Medical University Taiyuan Shanxi Recruiting
Tangdu hospital,fourth military medical university Xi’an Shanxi Recruiting
Tianjin Medical University General Hospital Tianjin Tianjin Municipality Recruiting

More Shanghai Pharmaceuticals Holding Co., Ltd trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05145361 on ClinicalTrials.gov ↗ ← All trials in China