A Clinical Study of B007 in the Treatment of Generalized Myasthenia Gravis.
NCT ID: NCT06447597
Last Updated: 2024-10-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2/PHASE3
104 participants
INTERVENTIONAL
2024-07-01
2026-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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B007
B007
B007 high dose and low dose： Subcutaneous injection was administered on days 1 and 15
Placebo
Placebo
B007 matched Placebo Subcutaneous injection was administered on days 1 and 15
Interventions
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B007
B007 high dose and low dose： Subcutaneous injection was administered on days 1 and 15
Placebo
B007 matched Placebo Subcutaneous injection was administered on days 1 and 15
Eligibility Criteria
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Inclusion Criteria
2. Subjects with generalized myasthenia gravis;
3. Serum AchR(Acetylcholine receptor)-Ab or MUSK-Ab was positive during screening;
4. MG-ADL ≥5 at screening and baseline;
5. Before randomization, subjects received at least one gMG stable dose of SoC, and maintain a stable dose throughout the test;
6. Subjects agree to use effective contraceptive methods for contraception from signing the informed consent form to 1 year after the last dose. Female subjects considered fertile by the investigator must have negative serum pregnancy tests before the first dose.
Exclusion Criteria
2. Subjects usingprescribed drugs;
3. Subjects with a prescribed disease or history of disease;
4. The subjects has prescribed examination abnormalities that are assessed as unsuitable for participation in the study by the investigator;
5. Known history of severe allergic reaction to humanized monoclonal antibodies, or known allergy to any component of B007;
6. Subjects who received live vaccine at the specified time before the first dose and are expected to receive the vaccine at the specified time after the last dose;
7. Subjects who have received major surgery or participated in other clinical trials within the prescribed time before screening;
8. Pregnant and lactating women;
9. Fertile female subjects do not agree to use effective contraception from signing the informed consent form to 1 years after the last dose.
10. Sexually active male subjects who do not intend to use an effective contraceptive method during the trial period or within1 years after the last dose, or male subjects who plan to donate sperm during the trial or within 1 year after the last dose;
11. A history of alcohol or drug abuse within the past 12 months;
12. Other conditions deemed unsuitable for participation in this study by the researchers.
18 Years
70 Years
ALL
No
Sponsors
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Shanghai Pharmaceuticals Holding Co., Ltd
INDUSTRY
Shanghai Jiaolian Drug Research and Development Co., Ltd
INDUSTRY
Responsible Party
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Locations
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Peking University First Hospital
Beijing, , China
The First Bethune Hospital of Jilin University
Changchun, , China
Xiangya Hospital Central South University
Changsha, , China
Sichuan Provincial People's Hospital
Chengdu, , China
Nanfang Hospital, Southern Medical University
Guangzhou, , China
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, , China
Shandong Provincial Qianfoshan Hospital
Jinan, , China
Shandong University Cheeloo College of Medicine
Jinan, , China
First People's Hospital of Yunnan Province
Kunming, , China
Jiangxi Provincial People's Hospital
Nanchang, , China
The Second Affiliated Hospital of Nanchang University
Nanchang, , China
Shandong University Cheeloo College of Medicine
Qingdao, , China
Huashan Hospital, Fudan University
Shanghai, , China
Shenzhen Hospital of University of Hong Kong
Shenzhen, , China
Renmin Hospital of Wuhan University
Wuhan, , China
Tongji Medical College of HUST
Wuhan, , China
Tangdu Hospital
Xi'an, , China
Affiliated Hospital of Zunyi Medical College
Zunyi, , China
Countries
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Central Contacts
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Facility Contacts
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Feng Gao
Role: primary
Hui Deng
Role: primary
Huan yang
Role: primary
Fei Xu
Role: primary
Haishan Jiang
Role: primary
Qing Ke
Role: primary
Ruisheng Duan
Role: primary
Wei Li
Role: primary
Qiang Meng
Role: primary
Rensi Xu
Role: primary
Jianglong Tu
Role: primary
Cuiping Zhao
Role: primary
jianying Xi
Role: primary
Haibing Xiao
Role: primary
Zuneng Lu
Role: primary
Bitao Bu
Role: primary
Ting Chang
Role: primary
Zucai Xu
Role: primary
Other Identifiers
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SPH-B007-303
Identifier Type: -
Identifier Source: org_study_id
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