Study of Telitacicept in Generalized Myasthenia Gravis
Myasthenia Gravis, Generalized
About this trial
This is an interventional treatment trial for Myasthenia Gravis, Generalized focused on measuring Myasthenia Gravis, Autoimmune Diseases, Muscle Weakness
Eligibility Criteria
Inclusion Criteria: Written informed consent provided; Male or female patients aged 18-80 years; Diagnosis with generalized myasthenia gravis; MGFA Class II, III, or IVa; AChR-Ab or MuSK-Ab positive; A total MG-ADL score of ≥ 6 with less than 50% of the total score due to ocular symptoms; QMG ≥ 8, with ≥ 4 items score at least 2; Have been on a stable MG SoC regimen. Exclusion Criteria: Patients with autoimmune diseases other than MG; Abnormal laboratory results; Significant cardiovascular disease, liver, kidney, respiratory, endocrine or hematologic disease, or other medical conditions that, in the opinion of the investigator, would preclude the subject's participation in the study or require hospitalization during the study; Acute or chronic infection requiring treatment; Current active hepatitis; HIV antibody positive; Current thymoma-associated immunodeficiency syndrome (Good's syndrome) or thymic surgery within 6 months prior to screening; Received or plan to receive any live vaccine within 3 months prior to randomization; Patients with malignant tumors; Allergy to biological products of human origin; Participation in any clinical trial 28 days prior to randomization or within 5 times the half-life of an investigational drug (whichever is longer); Pregnant or lactating women, and those intending to become pregnant during the trial; Patients considered unsuitable by the investigator to participate in the trial (e.g., patients with severe mental disorders); Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Sites / Locations
- The First Affiliated Hospital of Bengbu Medical CollegeRecruiting
- Anhui Provincial HospitalRecruiting
- Beijing HospitalRecruiting
- Xuanwu Hospital of Capital Medical UniversityRecruiting
- Fujian Medical University Union HospitalRecruiting
- Lanzhou University Second HospitalRecruiting
- The First Affiliated Hospital of Sun Yat-sen UniversityRecruiting
- Affiliated Hospital of Zunyi Medical UniversityRecruiting
- The Second Hospital of Hebei Medical UniversityRecruiting
- The Second Affiliated Hospital of Harbin Medical UniversityRecruiting
- Nanyang First People's HospitalRecruiting
- Henan Provincial People's HospitalRecruiting
- The First Affiliated Hospital of Zhengzhou UniversityRecruiting
- Renmin Hospital of Wuhan UniversityRecruiting
- Tongji Hospital, Tongji Medical College, Huazhong University of Science and TechnologyRecruiting
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyRecruiting
- Wuhan Hospital of Traditional Chinese and Western Medicine (Wuhan No.1 Hospital)Recruiting
- Zhongnan Hospital of Wuhan UniversityRecruiting
- Third Xiangya Hospital of Central South UniversityRecruiting
- Xiangya Hospital of Central South UniversityRecruiting
- Inner Mongolia Autonomous Region People's HospitalRecruiting
- Nanjing First HospitalRecruiting
- The First Affiliated Hospital of Soochow UniversityRecruiting
- Jiangxi Provincial People's HospitalRecruiting
- China-Japan Union Hospital of Jilin UniversityRecruiting
- The First Hospital of Jilin UniversityRecruiting
- Dalian Municipal Central HospitalRecruiting
- The First Affiliated Hospital of Dalian Medical UniversityRecruiting
- The Second Affiliated Hospital of Dalian Medical UniversityRecruiting
- The First Affiliated Hospital of Jinzhou Medical UniversityRecruiting
- Shengjing Hospital Affiliated to China Medical UniversityRecruiting
- The First Hospital of China Medical UniversityRecruiting
- The People's Hospital of Liaoning ProvinceRecruiting
- The Second Affiliated Hospital of PLA Air Force Military Medical UniversityRecruiting
- Xi'an Hi-tech HospitalRecruiting
- Xianyang Hospital of Yan'an UniversityRecruiting
- Qilu Hospital of Shandong UniversityRecruiting
- Jining No.1 People's HospitalRecruiting
- Huashan Hospital Affiliated to Fudan UniversityRecruiting
- Shanxi Bethune HospitalRecruiting
- Shanxi Provincial People's HospitalRecruiting
- The First Hospital of Shanxi Medical UniversityRecruiting
- West China Hospital, Sichuan UniversityRecruiting
- Affiliated Hospital of North Sichuan Medical CollegeRecruiting
- First Affiliated Hospital of Xinjiang Medical UniversityRecruiting
- The First Affiliated Hospital of Kunming Medical UniversityRecruiting
- The First People's Hospital of Yunnan ProvinceRecruiting
- The Second Affiliated Hospital of Kunming Medical UniversityRecruiting
- Sir Run Run Shaw Hospital, affiliated with to Zhejiang University College of MedicineRecruiting
- Zhejiang Provincial People's HospitalRecruiting
- The First Affiliated Hospital of Wenzhou Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Telitacicept
Placebo
Participants will receive subcutaneous Telitacicept 240 mg once a week for a total of 48 doses in addition to MG SoC.
Participants will receive subcutaneous placebo once a week for a total of 24 doses (part A) and then weekly subcutaneous Telitacicept 240 mg for 24 doses (part B) in addition to MG SoC.