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Brief Title: Study of Telitacicept in Generalized Myasthenia Gravis
Official Title: A Multi-center, Randomized, Double-blind, Placebo-controlled, Phase III Study of Telitacicept in Patients With Generalized Myasthenia Gravis
Study ID: NCT05737160
Brief Summary: The purpose of this study is to evaluate the efficacy and safety of Telitacicept in the treatment of patients with generalized myasthenia gravis.
Detailed Description: This study consists of a screening period, a double-blind treatment period (part A) and an open-label treatment period (part B). After screening, eligible subjects will be randomized in a 1: 1 ratio to receive either subcutaneous Telitacicept 240 mg or placebo once a week for 24 doses (part A). Completing part A, subjects will automatically enter part B. In part B, all subjects will receive weekly subcutaneous Telitacicept 240 mg for 24 weeks.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
The First Affiliated Hospital of Bengbu Medical College, Bengbu, Anhui, China
Anhui Provincial Hospital, Hefei, Anhui, China
Beijing Hospital, Beijing, Beijing, China
Xuanwu Hospital of Capital Medical University, Beijing, Beijing, China
Fujian Medical University Union Hospital, Fuzhou, Fujian, China
Lanzhou University Second Hospital, Lanzhou, Gansu, China
The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, China
Affiliated Hospital of Zunyi Medical University, Zunyi, Guizhou, China
The Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, China
The Second Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang, China
Nanyang First People's Hospital, Nanyang, Henan, China
Henan Provincial People's Hospital, Zhengzhou, Henan, China
The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China
Renmin Hospital of Wuhan University, Wuhan, Hubei, China
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China
Wuhan Hospital of Traditional Chinese and Western Medicine (Wuhan No.1 Hospital), Wuhan, Hubei, China
Zhongnan Hospital of Wuhan University, Wuhan, Hubei, China
Third Xiangya Hospital of Central South University, Changsha, Hunan, China
Xiangya Hospital of Central South University, Changsha, Hunan, China
Inner Mongolia Autonomous Region People's Hospital, Huhhot, Inner Mongolia, China
Nanjing First Hospital, Nanjing, Jiangsu, China
The First Affiliated Hospital of Soochow University, Suzhou, Jiangsu, China
Jiangxi Provincial People's Hospital, Nanchang, Jiangxi, China
China-Japan Union Hospital of Jilin University, Changchun, Jilin, China
The First Hospital of Jilin University, Changchun, Jilin, China
Dalian Municipal Central Hospital, Dalian, Liaoning, China
The First Affiliated Hospital of Dalian Medical University, Dalian, Liaoning, China
The Second Affiliated Hospital of Dalian Medical University, Dalian, Liaoning, China
The First Affiliated Hospital of Jinzhou Medical University, Jinzhou, Liaoning, China
Shengjing Hospital Affiliated to China Medical University, Shenyang, Liaoning, China
The First Hospital of China Medical University, Shenyang, Liaoning, China
The People's Hospital of Liaoning Province, Shenyang, Liaoning, China
The Second Affiliated Hospital of PLA Air Force Military Medical University, Xi'an, Shaanxi, China
Xi'an Hi-tech Hospital, Xi'an, Shaanxi, China
Xianyang Hospital of Yan'an University, Xianyang, Shaanxi, China
Qilu Hospital of Shandong University, Jinan, Shandong, China
Jining No.1 People's Hospital, Jining, Shandong, China
Huashan Hospital Affiliated to Fudan University, Shanghai, Shanghai, China
Shanxi Bethune Hospital, Taiyuan, Shanxi, China
Shanxi Provincial People's Hospital, Taiyuan, Shanxi, China
The First Hospital of Shanxi Medical University, Taiyuan, Shanxi, China
West China Hospital, Sichuan University, Chengdu, Sichuan, China
Affiliated Hospital of North Sichuan Medical College, Nanchong, Sichuan, China
First Affiliated Hospital of Xinjiang Medical University, Urumqi, Xinjiang, China
The First Affiliated Hospital of Kunming Medical University, Kunming, Yunnan, China
The First People's Hospital of Yunnan Province, Kunming, Yunnan, China
The Second Affiliated Hospital of Kunming Medical University, Kunming, Yunnan, China
Sir Run Run Shaw Hospital, affiliated with to Zhejiang University College of Medicine, Hangzhou, Zhejiang, China
Zhejiang Provincial People's Hospital, Hangzhou, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China