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RECRUITINGPhase 2 / Phase 3INTERVENTIONAL

A Clinical Study of B007 in the Treatment of Generalized Myasthenia Gravis.

A Randomized, Double-blind, Placebo-controlled, Multicenter Phase II/III Clinical Study to Evaluate the Efficacy and Safety of B007 in Subjects With Generalized Myasthenia Gravis

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

The purpose of this study is to evaluate the efficacy and safety of B007 in subjects with generalized myasthenia gravis.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Sign willing to sign a consent form form; 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 willing to sign a consent form 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. Who Should NOT Join This Trial: 1. Subjects with MGFA I and V type; 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 willing to sign a consent form 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Sign informed consent form; 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: 1. Subjects with MGFA I and V type; 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.

Treatments Being Tested

DRUG

B007

B007 high dose and low dose: Subcutaneous injection was administered on days 1 and 15

DRUG

Placebo

B007 matched Placebo Subcutaneous injection was administered on days 1 and 15

Locations (18)

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