A Clinical Study of B007 in the Treatment of Pemphigus.

Официальное название

A Phase II/III Clinical Study to Evaluate the Efficacy and Safety of B007 in Subjects With Pemphigus.

Обзор

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

Вмешательства

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

Первичные конечные точки

• Proportion of subjects：Complete remission with minimal treatment [Срок оценки: Approximately36 weeks]

Вторичные конечные точки (6)

• The number of relapses of the disease [Срок оценки: Approximately 1 years]
• Proportion of subjects：Partial remission [Срок оценки: Approximately 36weeks]
• Change: PDAI（Pemphigus disease area index） [Срок оценки: Approximately 36 weeks]
• CR/PR Proportion of subjects：Complete remission /Partial remission [Срок оценки: Approximately 52 weeks]
• DoR （Duration of Response） [Срок оценки: Approximately 1 years]
• Incidence of Treatment-Emergent Adverse Events [Срок оценки: Approximately 1 years]

Критерии участия

Критерии включения

• Subjects who voluntarily participate in this study and sign informed consent form;
• Subjects who meet the clinical manifestations of pemphigus and are clinically diagnosed as prescribed diseases;
• Subjects with first diagnosis or relapse;
• Subjects who have the ability to follow the study protocol as determined by the investigator.

Критерии исключения

• Subjects diagnosed with prescribed diseases;
• Since the diagnosis of pemphigus, Disease duration>4 years;
• Subjects using prescribed drugs;
• Presence of a specified disease or history of disease;
• The subjects has prescribed examination abnormalities that are assessed as unsuitable for participation in the study by the investigator;
• A history of severe allergy or allergic reaction to human or mouse monoclonal antibodies; known contraindications to orally prescribed drugs;
• Subjects who participate in another interventional clinical trial at a specified time before randomization;
• 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;
• Pregnant and lactating women;
• Fertile female subjects do not agree to use effective contraception from signing the informed consent form to the prescribed time after the last dose.

Women who are considered fertile by the investigator must have negative serum pregnancy tests before starting the drug;

• Sexually active male subjects who do not intend to use an effective contraceptive method during the trial period or within specified time after the last dose, or male subjects who plan to donate sperm at a specified time during the trial or after the last dose.
• 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

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 12 центров

• Peking University First Hospital — Пекин
• The Second Xiangya Hospital of Central South University — Чанша
• Chengdu Second People's Hospital — Чэнду
• West China Hospital, Sichuan University — Чэнду
• The First Affiliated Hospital of Chongqing Medical University — Чунцин
• The First Affiliated Hospital of Fujian Medical University — Фучжоу
• Dermatology Hospital of Southern Medical University — Гуанчжоу
• Guangdong Provincial People's Hospital — Гуанчжоу
• … и ещё 4 центра

Идентификаторы

NCT: NCT06454357 · SPH-B007-304

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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