Myasthenia Gravis, Generalized Clinical Trial
Official title:
A Multi-center, Randomized, Double-blind, Placebo-controlled, Phase III Study of Telitacicept in Patients With Generalized Myasthenia Gravis
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 |
The purpose of this study is to evaluate the efficacy and safety of Telitacicept in the treatment of patients with generalized myasthenia gravis.
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
RemeGen Co., Ltd. |
China,
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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