A Clinical Study of B007 in the Treatment of Generalized Myasthenia Gravis.

Официальное название

A Randomized, Double-blind, Placebo-controlled, Multicenter Phase II/III Clinical Study to Evaluate the Efficacy and Safety of B007 in Subjects With Generalized Myasthenia Gravis

Обзор

The purpose of this study is to evaluate the efficacy and safety of B007 in subjects with generalized myasthenia gravis.

Вмешательства

• Препарат B007
  B007 high dose and low dose： Subcutaneous injection was administered on days 1 and 15
• Препарат Placebo
  B007 matched Placebo Subcutaneous injection was administered on days 1 and 15

Первичные конечные точки

• Proportion of subjects：MG-ADL（Myasthenia gravis-activities of daily living profile） decreased by ≥2 [Срок оценки: Approximately 16 weeks]

Вторичные конечные точки (5)

• Proportion of subjects：subjects without SoC（Standard of Care） change and MG-ADL decreased by ≥2 [Срок оценки: Approximately 24 weeks]
• Proportion of subjects：subjects without SoC change and QMG(Quantitative Myasthenia Gravis score) decreased by ≥3 [Срок оценки: Approximately 24 weeks]
• Changes in MGQoL15r (Myasthenia gravis quality of life15-item revised) from baseline. [Срок оценки: Approximately 24 weeks]
• Changes in MGC (Myasthenia gravis composite) from baseline. [Срок оценки: Approximately 24 weeks]
• Incidence of Treatment-Emergent Adverse Events [Срок оценки: Approximately 1 years]

Критерии участия

Критерии включения

• Sign informed consent form;
• Subjects with generalized myasthenia gravis;
• Serum AchR(Acetylcholine receptor)-Ab or MUSK-Ab was positive during screening;
• MG-ADL ≥5 at screening and baseline;
• Before randomization, subjects received at least one gMG stable dose of SoC, and maintain a stable dose throughout the test;
• Subjects agree to use effective contraceptive methods for contraception from signing the informed consent form to 1 year after the last dose. Female subjects considered fertile by the investigator must have negative serum pregnancy tests before the first dose.

Критерии исключения

• Subjects with MGFA I and V type;
• Subjects usingprescribed drugs;
• Subjects with a prescribed disease or history of disease;
• The subjects has prescribed examination abnormalities that are assessed as unsuitable for participation in the study by the investigator;
• Known history of severe allergic reaction to humanized monoclonal antibodies, or known allergy to any component of B007;
• Subjects who received live vaccine at the specified time before the first dose and are expected to receive the vaccine at the specified time after the last dose;
• Subjects who have received major surgery or participated in other clinical trials within the prescribed time before screening;
• Pregnant and lactating women;
• Fertile female subjects do not agree to use effective contraception from signing the informed consent form to 1 years after the last dose.
• Sexually active male subjects who do not intend to use an effective contraceptive method during the trial period or within1 years after the last dose, or male subjects who plan to donate sperm during the trial or within 1 year after the last dose;
• A history of alcohol or drug abuse within the past 12 months;
• Other conditions deemed unsuitable for participation in this study by the researchers.

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 · 18 центров

• Peking University First Hospital — Пекин
• The First Bethune Hospital of Jilin University — Changchun
• Xiangya Hospital Central South University — Чанша
• Sichuan Provincial People's Hospital — Чэнду
• Nanfang Hospital, Southern Medical University — Гуанчжоу
• The First Affiliated Hospital, Zhejiang University School of Medicine — Ханчжоу
• Shandong Provincial Qianfoshan Hospital — Цзинань
• Shandong University Cheeloo College of Medicine — Цзинань
• … и ещё 10 центров

Идентификаторы

NCT: NCT06447597 · SPH-B007-303

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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