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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| B001 injection | Experimental | Subjects randomized to this arm will receive B001 twice, at day 1 and day 15, up to the end of the study. |
|
| Placebo | Placebo Comparator | Subjects randomized to this arm will receive Placebo twice, at day 1 and day 15, up to the end of the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| B001 injection | Drug | B001 injection 50mg/5mL Intravenous solution |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Dose-limiting toxicity (DLT) | Measurement of DLT in all subjects. | Up to 18 days. |
| Evaluate incidence of treatment-emergent adverse events [Safety and Tolerability]. | Up to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum serum concentration (Cmax) of B001. | To characterize the PK (Pharmacokinetics) of B001. | Through study completion, up to 2 years |
| Time of maximum serum concentration (Tmax) of B001. | To characterize the PK (Pharmacokinetics) of B001. |
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Inclusion Criteria:
Exclusion Criteria:
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.
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.
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.
Known active infection within 3 months prior to baseline
Pregnancy or lactation.
History of severe allergic reaction to a biologic agent
Evidence of chronic active hepatitis B or C
Evidence of active tuberculosis
Following laboratory abnormalities at screening*:
History of drug or alcohol abuse within 6 months prior to baseline
Receipt of any live or live attenuated vaccine within 4 weeks prior to baseline
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fu-Dong Shi, MD,PhD | Contact | 022-60814587 | Shifudong219@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Fu-Dong Shi, MD,PhD | Tianjin Medical University General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tiantan Hospital Capital Medical University | Recruiting | Beijing | Beijing Municipality | 100050 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42079612 | Derived | Jia D, Wang H, Jiang W, Shen Y, Guo J, Zhao D, Zhang M, Meng H, Xue H, Song Y, Yao Q, Xie N, Zhang C. A novel recombinant anti-cluster of differentiation 20 humanized monoclonal antibody (B001) for the treatment of neuromyelitis optica spectrum disorder: a phase 1, multicenter randomized, double-blind trial. Front Immunol. 2026 Apr 16;17:1676908. doi: 10.3389/fimmu.2026.1676908. eCollection 2026. |
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| ID | Term |
|---|---|
| D009471 | Neuromyelitis Optica |
| ID | Term |
|---|---|
| D009188 | Myelitis, Transverse |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
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| Placebo |
| Biological |
Placebo 5mL Intravenous solution |
|
| Through study completion, up to 2 years |
| Area under the serum concentration-time curve (AUC) of the Dosing Interval (0-14D) of B001. | To characterize the PK (Pharmacokinetics) of B001. | Through study completion, up to 2 years |
| Area under the serum concentration-time curve (AUC) of the Dosing Interval (0-Last) of B001. | To characterize the PK (Pharmacokinetics) of B001. | Through study completion, up to 2 years |
| Area under the serum concentration-time curve (AUC) of the Dosing Interval (0-infinity) of B001. | To characterize the PK (Pharmacokinetics) of B001. | Through study completion, up to 2 years |
| Accumulation ratio of maximum serum concentration (Rac_Cmax) of B001. | To characterize the PK (Pharmacokinetics) of B001. | Through study completion, up to 2 years |
| Accumulation ratio of area under the serum concentration-time curve (Rac_AUC) of the Dosing Interval (0-14D) of B001. | To characterize the PK (Pharmacokinetics) of B001. | Through study completion, up to 2 years |
| Terminal rate constant(λz) of B001. | To characterize the PK (Pharmacokinetics) of B001. | Through study completion, up to 2 years |
| Half-life (t1/2) of B001. | To characterize the PK (Pharmacokinetics) of B001. | Through study completion, up to 2 years |
| Total clearance(CL) of B001. | To characterize the PK (Pharmacokinetics) of B001. | Through study completion, up to 2 years |
| Volume of distribution(Vz) of B001. | To characterize the PK (Pharmacokinetics) of B001. | Through study completion, up to 2 years |
| Percentage of area under the serum concentration-time curve (AUC 0-infinity) obtained by extrapolation (%AUCex) of B001. | To characterize the PK (Pharmacokinetics) of B001. | Through study completion, up to 2 years |
| Percentage of subjects with ADA to B001 and neutralizing resistance (Nab) | Through study completion, up to 2 years |
| Time to First Protocol-Defined Relapse (TFR) in the Double-Blind Period | Through study completion, up to 2 years |
| Change in Expanded Disability Status Scale (EDSS) Score | The EDSS provides a total score on a scale that ranges from 0 to 10 in 0.5 increments that represent higher levels of disability. Increasing disability is reflected in an increasing EDSS score. | Through study completion, up to 2 years |
| Time to EDSS Worsening | Through study completion, up to 2 years |
| First Hospital of Shanxi Medical University | Recruiting | Taiyuan | Shanxi | 030001 | China |
|
| Tangdu hospital,fourth military medical university | Recruiting | Xi’an | Shanxi | 710038 | China |
|
| Tianjin Medical University General Hospital | Recruiting | Tianjin | Tianjin Municipality | 300052 | China |
|
| D009902 | Optic Neuritis |
| D009901 | Optic Nerve Diseases |
| D003389 | Cranial Nerve Diseases |
| D003711 | Demyelinating Diseases |
| D005128 | Eye Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |