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

Официальное название

A Phase Ib Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of B001 in Subjects With Aquaporin-4 Antibody (AQP4-IgG) Positive Neuromyelitis Optic Spectrum Disorder (NMOSD)

Обзор

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.

Вмешательства

• Препарат B001 injection
  B001 injection 50mg/5mL Intravenous solution
• Биопрепарат Placebo
  Placebo 5mL Intravenous solution

Первичные конечные точки

• Dose-limiting toxicity (DLT) [Срок оценки: Up to 18 days.]
• Evaluate incidence of treatment-emergent adverse events [Safety and Tolerability]. [Срок оценки: Up to 1 year]

Вторичные конечные точки (12)

• Maximum serum concentration (Cmax) of B001. [Срок оценки: Through study completion, up to 2 years]
• Time of maximum serum concentration (Tmax) of B001. [Срок оценки: Through study completion, up to 2 years]
• Area under the serum concentration-time curve (AUC) of the Dosing Interval (0-14D) of B001. [Срок оценки: Through study completion, up to 2 years]
• Area under the serum concentration-time curve (AUC) of the Dosing Interval (0-Last) of B001. [Срок оценки: Through study completion, up to 2 years]
• Area under the serum concentration-time curve (AUC) of the Dosing Interval (0-infinity) of B001. [Срок оценки: Through study completion, up to 2 years]
• Accumulation ratio of maximum serum concentration (Rac_Cmax) of B001. [Срок оценки: 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. [Срок оценки: Through study completion, up to 2 years]
• Terminal rate constant(λz) of B001. [Срок оценки: Through study completion, up to 2 years]
• Half-life (t1/2) of B001. [Срок оценки: Through study completion, up to 2 years]
• Total clearance(CL) of B001. [Срок оценки: Through study completion, up to 2 years]
• Volume of distribution(Vz) of B001. [Срок оценки: 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. [Срок оценки: Through study completion, up to 2 years]

Критерии участия

Критерии включения

• NMOSD as defined by either of the following 2015 criteria with anti-AQP4 antibody (Ab) seropositive status at screening
• Clinical evidence of at least 1 documented relapse in last 12 months prior to screening
• Expanded Disability Status Scale (EDSS) score from 0 to 7.5 inclusive at screening
• Age 18 to 70 years, inclusive at the time of informed consent

Критерии исключения

• 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\*:

• White blood cells (WBC) <4.0 x10\^3/microliter (μL)
• Absolute neutrophil count (ANC)
• Absolute lymphocyte count <0.5 x10\^3/μL
• Platelet count <80 x 10\^9/ L
• Aspartate aminotransferase (AST) or alanine aminotransferase
• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Китай · 4 центра

• Beijing Tiantan Hospital Capital Medical University — Пекин
• First Hospital of Shanxi Medical University — Taiyuan
• Tangdu hospital,fourth military medical university — Xi’an
• Tianjin Medical University General Hospital — Тяньцзинь

Публикации

• 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. PMID 42079612

Идентификаторы

NCT: NCT05145361 · B001-103

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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