Trial Title:
Study of Telitacicept in Generalized Myasthenia Gravis
NCT ID:
NCT05737160
Condition:
Myasthenia Gravis, Generalized
Conditions: Official terms:
Myasthenia Gravis
Muscle Weakness
Conditions: Keywords:
Myasthenia Gravis
Autoimmune Diseases
Muscle Weakness
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Biological
Intervention name:
Telitacicept
Description:
Administered as an SC infusion
Arm group label:
Telitacicept
Other name:
RC18
Intervention type:
Drug
Intervention name:
Placebo
Description:
Administered as an SC infusion
Arm group label:
Placebo
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Written informed consent provided;
2. Male or female patients aged 18-80 years;
3. Diagnosis with generalized myasthenia gravis;
4. MGFA Class II, III, or IVa;
5. AChR-Ab or MuSK-Ab positive;
6. A total MG-ADL score of ≥ 6 with less than 50% of the total score due to ocular
symptoms;
7. QMG ≥ 8, with ≥ 4 items score at least 2;
8. Have been on a stable MG SoC regimen.
Exclusion Criteria:
1. Patients with autoimmune diseases other than MG;
2. Abnormal laboratory results；
3. 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;
4. Acute or chronic infection requiring treatment;
5. Current active hepatitis;
6. HIV antibody positive;
7. Current thymoma-associated immunodeficiency syndrome (Good's syndrome) or thymic
surgery within 6 months prior to screening;
8. Received or plan to receive any live vaccine within 3 months prior to randomization;
9. Patients with malignant tumors;
10. Allergy to biological products of human origin;
11. Participation in any clinical trial 28 days prior to randomization or within 5 times
the half-life of an investigational drug (whichever is longer);
12. Pregnant or lactating women, and those intending to become pregnant during the
trial;
13. 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The First Affiliated Hospital of Bengbu Medical College
Address:
City:
Bengbu
Country:
China
Status:
Recruiting
Facility:
Name:
Anhui Provincial Hospital
Address:
City:
Hefei
Country:
China
Status:
Recruiting
Facility:
Name:
Beijing Hospital
Address:
City:
Beijing
Country:
China
Status:
Recruiting
Facility:
Name:
Xuanwu Hospital of Capital Medical University
Address:
City:
Beijing
Country:
China
Status:
Recruiting
Facility:
Name:
Fujian Medical University Union Hospital
Address:
City:
Fuzhou
Country:
China
Status:
Recruiting
Facility:
Name:
Lanzhou University Second Hospital
Address:
City:
Lanzhou
Country:
China
Status:
Recruiting
Facility:
Name:
The First Affiliated Hospital of Sun Yat-sen University
Address:
City:
Guangzhou
Country:
China
Status:
Recruiting
Facility:
Name:
Affiliated Hospital of Zunyi Medical University
Address:
City:
Zunyi
Country:
China
Status:
Recruiting
Facility:
Name:
The Second Hospital of Hebei Medical University
Address:
City:
Shijiazhuang
Country:
China
Status:
Recruiting
Facility:
Name:
The Second Affiliated Hospital of Harbin Medical University
Address:
City:
Harbin
Country:
China
Status:
Recruiting
Facility:
Name:
Nanyang First People's Hospital
Address:
City:
Nanyang
Country:
China
Status:
Recruiting
Facility:
Name:
Henan Provincial People's Hospital
Address:
City:
Zhengzhou
Country:
China
Status:
Recruiting
Facility:
Name:
The First Affiliated Hospital of Zhengzhou University
Address:
City:
Zhengzhou
Country:
China
Status:
Recruiting
Facility:
Name:
Renmin Hospital of Wuhan University
Address:
City:
Wuhan
Country:
China
Status:
Recruiting
Facility:
Name:
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Address:
City:
Wuhan
Country:
China
Status:
Recruiting
Facility:
Name:
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Address:
City:
Wuhan
Country:
China
Status:
Recruiting
Facility:
Name:
Wuhan Hospital of Traditional Chinese and Western Medicine (Wuhan No.1 Hospital)
Address:
City:
Wuhan
Country:
China
Status:
Recruiting
Facility:
Name:
Zhongnan Hospital of Wuhan University
Address:
City:
Wuhan
Country:
China
Status:
Recruiting
Facility:
Name:
Third Xiangya Hospital of Central South University
Address:
City:
Changsha
Country:
China
Status:
Recruiting
Facility:
Name:
Xiangya Hospital of Central South University
Address:
City:
Changsha
Country:
China
Status:
Recruiting
Facility:
Name:
Inner Mongolia Autonomous Region People's Hospital
Address:
City:
Huhhot
Country:
China
Status:
Recruiting
Facility:
Name:
Nanjing First Hospital
Address:
City:
Nanjing
Country:
China
Status:
Recruiting
Facility:
Name:
The First Affiliated Hospital of Soochow University
Address:
City:
Suzhou
Country:
China
Status:
Recruiting
Facility:
Name:
Jiangxi Provincial People's Hospital
Address:
City:
Nanchang
Country:
China
Status:
Recruiting
Facility:
Name:
China-Japan Union Hospital of Jilin University
Address:
City:
Changchun
Country:
China
Status:
Recruiting
Facility:
Name:
The First Hospital of Jilin University
Address:
City:
Changchun
Country:
China
Status:
Recruiting
Facility:
Name:
Dalian Municipal Central Hospital
Address:
City:
Dalian
Country:
China
Status:
Recruiting
Facility:
Name:
The First Affiliated Hospital of Dalian Medical University
Address:
City:
Dalian
Country:
China
Status:
Recruiting
Facility:
Name:
The Second Affiliated Hospital of Dalian Medical University
Address:
City:
Dalian
Country:
China
Status:
Recruiting
Facility:
Name:
The First Affiliated Hospital of Jinzhou Medical University
Address:
City:
Jinzhou
Country:
China
Status:
Recruiting
Facility:
Name:
Shengjing Hospital Affiliated to China Medical University
Address:
City:
Shenyang
Country:
China
Status:
Recruiting
Facility:
Name:
The First Hospital of China Medical University
Address:
City:
Shenyang
Country:
China
Status:
Recruiting
Facility:
Name:
The People's Hospital of Liaoning Province
Address:
City:
Shenyang
Country:
China
Status:
Recruiting
Facility:
Name:
The Second Affiliated Hospital of PLA Air Force Military Medical University
Address:
City:
Xi'an
Country:
China
Status:
Recruiting
Facility:
Name:
Xi'an Hi-tech Hospital
Address:
City:
Xi'an
Country:
China
Status:
Recruiting
Facility:
Name:
Xianyang Hospital of Yan'an University
Address:
City:
Xianyang
Country:
China
Status:
Recruiting
Facility:
Name:
Qilu Hospital of Shandong University
Address:
City:
Jinan
Country:
China
Status:
Recruiting
Facility:
Name:
Jining No.1 People's Hospital
Address:
City:
Jining
Country:
China
Status:
Recruiting
Facility:
Name:
Huashan Hospital Affiliated to Fudan University
Address:
City:
Shanghai
Country:
China
Status:
Recruiting
Facility:
Name:
Shanxi Bethune Hospital
Address:
City:
Taiyuan
Country:
China
Status:
Recruiting
Facility:
Name:
Shanxi Provincial People's Hospital
Address:
City:
Taiyuan
Country:
China
Status:
Recruiting
Facility:
Name:
The First Hospital of Shanxi Medical University
Address:
City:
Taiyuan
Country:
China
Status:
Recruiting
Facility:
Name:
West China Hospital, Sichuan University
Address:
City:
Chengdu
Country:
China
Status:
Recruiting
Facility:
Name:
Affiliated Hospital of North Sichuan Medical College
Address:
City:
Nanchong
Country:
China
Status:
Recruiting
Facility:
Name:
First Affiliated Hospital of Xinjiang Medical University
Address:
City:
Urumqi
Country:
China
Status:
Recruiting
Facility:
Name:
The First Affiliated Hospital of Kunming Medical University
Address:
City:
Kunming
Country:
China
Status:
Recruiting
Facility:
Name:
The First People's Hospital of Yunnan Province
Address:
City:
Kunming
Country:
China
Status:
Recruiting
Facility:
Name:
The Second Affiliated Hospital of Kunming Medical University
Address:
City:
Kunming
Country:
China
Status:
Recruiting
Facility:
Name:
Sir Run Run Shaw Hospital, affiliated with to Zhejiang University College of Medicine
Address:
City:
Hangzhou
Country:
China
Status:
Recruiting
Facility:
Name:
Zhejiang Provincial People's Hospital
Address:
City:
Hangzhou
Country:
China
Status:
Recruiting
Facility:
Name:
The First Affiliated Hospital of Wenzhou Medical University
Address:
City:
Wenzhou
Country:
China
Status:
Recruiting
Start date:
March 28, 2023
Completion date:
May 2027
Lead sponsor:
Agency:
RemeGen Co., Ltd.
Agency class:
Industry
Source:
RemeGen Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05737160
