Study of Telitacicept in Generalized Myasthenia Gravis
- Conditions
- Myasthenia Gravis, Generalized
- Interventions
- Drug: PlaceboBiological: Telitacicept
- Registration Number
- NCT05737160
- Lead Sponsor
- RemeGen Co., Ltd.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo 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. Telitacicept Telitacicept Participants will receive subcutaneous Telitacicept 240 mg once a week for a total of 48 doses in addition to MG SoC.
- Primary Outcome Measures
Name Time Method Change from baseline in MG-ADL Week 24 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.
- Secondary Outcome Measures
Name Time Method Change from baseline in QMG Weeks 12, 24, 36, 48 The quantitative myasthenia gravis (QMG) score is a 13-item scale used to quantify disease severity in myasthenia gravis (MG). Total QMG score ranges from 0 (no myasthenic findings) to 39 (maximal myasthenic deficits).
Change from baseline in MG-ADL Weeks12, 36, 48 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.
Proportion of subjects with ≥ 3 points reduction from baseline in MG-ADL Weeks 24, 48 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.
Proportion of subjects with a decrease of ≥ 5 points from baseline in QMG Weeks 24, 48 The quantitative myasthenia gravis (QMG) score is a 13-item scale used to quantify disease severity in myasthenia gravis (MG). Total QMG score ranges from 0 (no myasthenic findings) to 39 (maximal myasthenic deficits).
Trial Locations
- Locations (51)
Nanjing First Hospital
🇨🇳Nanjing, Jiangsu, China
The First Affiliated Hospital of Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China
Henan Provincial People's Hospital
🇨🇳Zhengzhou, Henan, China
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
🇨🇳Wuhan, Hubei, China
Anhui Provincial Hospital
🇨🇳Hefei, Anhui, China
Affiliated Hospital of Zunyi Medical University
🇨🇳Zunyi, Guizhou, China
The Second Affiliated Hospital of Harbin Medical University
🇨🇳Harbin, Heilongjiang, China
Nanyang First People's Hospital
🇨🇳Nanyang, Henan, China
The First Affiliated Hospital of Zhengzhou University
🇨🇳Zhengzhou, Henan, China
Renmin Hospital of Wuhan University
🇨🇳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
Third Xiangya Hospital of Central South University
🇨🇳Changsha, Hunan, China
Zhongnan Hospital of Wuhan University
🇨🇳Wuhan, Hubei, China
Xiangya Hospital of Central South University
🇨🇳Changsha, Hunan, China
Inner Mongolia Autonomous Region People's Hospital
🇨🇳Huhhot, Inner Mongolia, 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
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
Xi'an Hi-tech Hospital
🇨🇳Xi'an, Shaanxi, China
Xianyang Hospital of Yan'an University
🇨🇳Xianyang, Shaanxi, 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
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
The First Affiliated Hospital of Bengbu Medical College
🇨🇳Bengbu, Anhui, China
Beijing Hospital
🇨🇳Beijing, Beijing, China
Fujian Medical University Union Hospital
🇨🇳Fuzhou, Fujian, China
Lanzhou University Second Hospital
🇨🇳Lanzhou, Gansu, China
Xuanwu Hospital of Capital Medical University
🇨🇳Beijing, Beijing, China
The Second Hospital of Hebei Medical University
🇨🇳Shijiazhuang, Hebei, China
Dalian Municipal Central Hospital
🇨🇳Dalian, Liaoning, China
The Second Affiliated Hospital of PLA Air Force Military Medical University
🇨🇳Xi'an, Shaanxi, China
Qilu Hospital of Shandong University
🇨🇳Jinan, Shandong, China
The First Hospital of Shanxi Medical University
🇨🇳Taiyuan, Shanxi, China
The People's Hospital of Liaoning Province
🇨🇳Shenyang, Liaoning, China