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The purpose of this study is to evaluate the efficacy and safety of Telitacicept in the treatment of patients with generalized myasthenia gravis.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telitacicept | Experimental | Participants will receive subcutaneous Telitacicept 240 mg once a week for a total of 48 doses in addition to MG SoC. |
|
| Placebo | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telitacicept | Biological | Administered as an SC infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Change from baseline in QMG |
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Inclusion Criteria:
Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Bengbu Medical College | Bengbu | Anhui | China | |||
| Anhui Provincial Hospital |
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| Placebo | Drug | Administered as an SC infusion |
|
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 |
| 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 |
| 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 |
| 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 |
| ID | Term |
|---|---|
| D009157 | Myasthenia Gravis |
| D001327 | Autoimmune Diseases |
| D018908 | Muscle Weakness |
| ID | Term |
|---|---|
| D020361 | Paraneoplastic Syndromes, Nervous System |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010257 | Paraneoplastic Syndromes |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D019636 | Neurodegenerative Diseases |
| D020511 | Neuromuscular Junction Diseases |
| D009468 | Neuromuscular Diseases |
| D007154 | Immune System Diseases |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| C000722462 | telitacicept |
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