Study of Telitacicept in Generalized Myasthenia Gravis
A Multi-center, Randomized, Double-blind, Placebo-controlled, Phase III Study of Telitacicept in Patients With Generalized Myasthenia Gravis
1 other identifier
interventional
114
1 country
51
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Mar 2023
51 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 12, 2023
CompletedFirst Posted
Study publicly available on registry
February 21, 2023
CompletedStudy Start
First participant enrolled
March 28, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 26, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 12, 2024
CompletedMay 23, 2025
October 1, 2024
1.7 years
February 12, 2023
May 19, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in MG-ADL
The MG-ADL is an 8-item patient-reported scale that measures MG symptoms and functional status. Each item ranges from 0 to 3 for a total score range of 0 to 24.
Week 24
Secondary Outcomes (4)
Change from baseline in MG-ADL
Weeks12, 36, 48
Change from baseline in QMG
Weeks 12, 24, 36, 48
Proportion of subjects with ≥ 3 points reduction from baseline in MG-ADL
Weeks 24, 48
Proportion of subjects with a decrease of ≥ 5 points from baseline in QMG
Weeks 24, 48
Study Arms (2)
Telitacicept
EXPERIMENTALParticipants will receive subcutaneous Telitacicept 240 mg once a week for a total of 48 doses in addition to MG SoC.
Placebo
PLACEBO COMPARATORParticipants 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Patients with autoimmune diseases other than MG;
- Abnormal laboratory results；
- Use of immunosuppressants other than standard therapy within 1 month before randomization;
- Use of biologic agents targeting therapy, such as Rituximab or complement C5 inhibitors, within 6 months before randomization;
- Use of neonatal Fc receptor (FcRn) antagonists, intravenous immunoglobulin (IVIg), or plasmapheresis within 2 months before randomization;
- 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;
- Patients currently suffering from thymoma-associated immunodeficiency syndrome (Good's syndrome) or who underwent thymectomy within 6 months before 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;
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (51)
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, China
Anhui Provincial Hospital
Hefei, Anhui, China
Beijing Hospital
Beijing, Beijing Municipality, China
Xuanwu Hospital of Capital Medical University
Beijing, Beijing Municipality, 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
Hohhot, 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 Municipality, 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
Ürümqi, 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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 12, 2023
First Posted
February 21, 2023
Study Start
March 28, 2023
Primary Completion
November 26, 2024
Study Completion
December 12, 2024
Last Updated
May 23, 2025
Record last verified: 2024-10