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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05737160
Other study ID # 18C029
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date March 28, 2023
Est. completion date May 2027

Study information

Verified date October 2023
Source RemeGen Co., Ltd.
Contact Binghua Xiao
Phone 86-101-58076833
Email binghua.xiao@remegen.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy and safety of Telitacicept in the treatment of patients with generalized myasthenia gravis.


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 information / eligibility

Status Recruiting
Enrollment 100
Est. completion date May 2027
Est. primary completion date December 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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.

Study Design


Intervention

Biological:
Telitacicept
Administered as an SC infusion
Drug:
Placebo
Administered as an SC infusion

Locations

Country Name City State
China Beijing Hospital Beijing Beijing
China Xuanwu Hospital of Capital Medical University Beijing Beijing
China The First Affiliated Hospital of Bengbu Medical College Bengbu Anhui
China China-Japan Union Hospital of Jilin University Changchun Jilin
China The First Hospital of Jilin University Changchun Jilin
China Third Xiangya Hospital of Central South University Changsha Hunan
China Xiangya Hospital of Central South University Changsha Hunan
China West China Hospital, Sichuan University Chengdu Sichuan
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 Fujian Medical University Union Hospital Fuzhou Fujian
China The First Affiliated Hospital of Sun Yat-sen University Guangzhou Guangdong
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 Second Affiliated Hospital of Harbin Medical University Harbin Heilongjiang
China Anhui Provincial Hospital Hefei Anhui
China Inner Mongolia Autonomous Region People's Hospital Huhhot Inner Mongolia
China Qilu Hospital of Shandong University Jinan Shandong
China Jining No.1 People's Hospital Jining Shandong
China The First Affiliated Hospital of Jinzhou Medical University Jinzhou Liaoning
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 Lanzhou University Second Hospital Lanzhou Gansu
China Jiangxi Provincial People's Hospital Nanchang Jiangxi
China Affiliated Hospital of North Sichuan Medical College Nanchong Sichuan
China Nanjing First Hospital Nanjing Jiangsu
China Nanyang First People's Hospital Nanyang Henan
China Huashan Hospital Affiliated to Fudan University Shanghai Shanghai
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 Hospital of Hebei Medical University Shijiazhuang Hebei
China The First Affiliated Hospital of Soochow University Suzhou Jiangsu
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 First Affiliated Hospital of Xinjiang Medical University Urumqi Xinjiang
China The First Affiliated Hospital of Wenzhou Medical University Wenzhou Zhejiang
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 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 Henan Provincial People's Hospital Zhengzhou Henan
China The First Affiliated Hospital of Zhengzhou University Zhengzhou Henan
China Affiliated Hospital of Zunyi Medical University Zunyi Guizhou

Sponsors (1)

Lead Sponsor Collaborator
RemeGen Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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. Weeks12, 36, 48
Secondary Change from baseline in QMG 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). Weeks 12, 24, 36, 48
Secondary Proportion of subjects with = 3 points reduction 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. Weeks 24, 48
Secondary Proportion of subjects with a decrease of = 5 points from baseline in QMG 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). Weeks 24, 48
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