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RECRUITING
NCT06447597
PHASE2/PHASE3

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

Sponsor: Shanghai Jiaolian Drug Research and Development Co., Ltd

View on ClinicalTrials.gov

Summary

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

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

104

Start Date

2024-07-01

Completion Date

2026-06-30

Last Updated

2024-10-31

Healthy Volunteers

No

Interventions

DRUG

B007

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

DRUG

Placebo

B007 matched Placebo Subcutaneous injection was administered on days 1 and 15

Locations (18)

Peking University First Hospital

Beijing, China

The First Bethune Hospital of Jilin University

Changchun, China

Xiangya Hospital Central South University

Changsha, China

Sichuan Provincial People's Hospital

Chengdu, China

Nanfang Hospital, Southern Medical University

Guangzhou, China

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, China

Shandong Provincial Qianfoshan Hospital

Jinan, China

Shandong University Cheeloo College of Medicine

Jinan, China

First People's Hospital of Yunnan Province

Kunming, China

Jiangxi Provincial People's Hospital

Nanchang, China

The Second Affiliated Hospital of Nanchang University

Nanchang, China

Shandong University Cheeloo College of Medicine

Qingdao, China

Huashan Hospital, Fudan University

Shanghai, China

Shenzhen Hospital of University of Hong Kong

Shenzhen, China

Renmin Hospital of Wuhan University

Wuhan, China

Tongji Medical College of HUST

Wuhan, China

Tangdu Hospital

Xi'an, China

Affiliated Hospital of Zunyi Medical College

Zunyi, China