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A Clinical Study of B007 in the Treatment of Generalized Myasthenia Gravis.
Led by Shanghai Jiaolian Drug Research and Development Co., Ltd · Updated on 2026-04-30
104
Participants Needed
18
Research Sites
104 weeks
Total Duration
On this page
Sponsors
S
Shanghai Jiaolian Drug Research and Development Co., Ltd
Lead Sponsor
S
Shanghai Pharmaceuticals Holding Co., Ltd
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this study is to evaluate the efficacy and safety of B007 in subjects with generalized myasthenia gravis.
CONDITIONS
Official Title
A Clinical Study of B007 in the Treatment of Generalized Myasthenia Gravis.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form
- Diagnosis of generalized myasthenia gravis
- Positive serum acetylcholine receptor antibody (AchR-Ab) or MUSK antibody (MUSK-Ab) during screening
- MG-ADL score of 5 or higher at screening and baseline
- Receiving at least one stable dose of standard care for generalized myasthenia gravis before randomization and maintaining stable dose during the study
- Agree to use effective contraception from consent signing to 1 year after last dose; female subjects fertile by investigator must have negative pregnancy test before first dose
You will not qualify if you...
- Myasthenia Gravis Foundation of America (MGFA) type I or V
- Use of prescribed drugs contraindicated for the study
- Presence or history of specified diseases making participation unsuitable
- Abnormal examination results deemed unsuitable by investigator
- History of severe allergic reaction to humanized monoclonal antibodies or allergy to any component of B007
- Receipt of live vaccine within specified time before first dose or planned after last dose
- Major surgery or participation in other clinical trials within specified time before screening
- Pregnant or breastfeeding women
- Fertile females not agreeing to effective contraception during and 1 year after study
- Sexually active males not intending to use contraception during and 1 year after study or planning to donate sperm
- History of alcohol or drug abuse within past 12 months
- Other conditions making participation unsuitable as judged by researchers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 18 locations
1
Peking University First Hospital
Beijing, China
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2
The First Bethune Hospital of Jilin University
Changchun, China
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3
Xiangya Hospital Central South University
Changsha, China
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4
Sichuan Provincial People's Hospital
Chengdu, China
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5
Nanfang Hospital, Southern Medical University
Guangzhou, China
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6
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, China
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7
Shandong Provincial Qianfoshan Hospital
Jinan, China
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8
Shandong University Cheeloo College of Medicine
Jinan, China
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9
First People's Hospital of Yunnan Province
Kunming, China
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10
Jiangxi Provincial People's Hospital
Nanchang, China
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11
The Second Affiliated Hospital of Nanchang University
Nanchang, China
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12
Shandong University Cheeloo College of Medicine
Qingdao, China
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13
Huashan Hospital, Fudan University
Shanghai, China
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14
Shenzhen Hospital of University of Hong Kong
Shenzhen, China
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15
Renmin Hospital of Wuhan University
Wuhan, China
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16
Tongji Medical College of HUST
Wuhan, China
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17
Tangdu Hospital
Xi'an, China
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18
Affiliated Hospital of Zunyi Medical College
Zunyi, China
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Research Team
J
Jianying Xi
CONTACT
H
Huan Yang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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