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A Randomized, Double-blind, Placebo-controlled, Multicenter Phase II/III Clinical Study to Evaluate the Efficacy and Safety of B007 in Generalized Myasthenia Gravis
Led by Shanghai Jiaolian Drug Research and Development Co., Ltd · Updated on 2026-04-30
104
Participants Needed
18
Research Sites
N/A
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
Researchers are evaluating the effectiveness and safety of B007 in people with generalized myasthenia gravis, a condition that causes muscle weakness. This randomized, double-blind, placebo-controlled Phase II/III study aims to understand how well B007 works compared to a placebo in improving daily living activities affected by this condition. Participants will receive either a high or low dose of B007 or a matching placebo through subcutaneous injections on days 1 and 15. The study includes careful monitoring over approximately 16 to 24 weeks to assess changes in symptoms and quality of life, with a safety follow-up lasting about one year. During the trial, participants will be evaluated through various measures including the Myasthenia Gravis-Activities of Daily Living profile, quality of life questionnaires, and composite scores related to the condition. Researchers will also track any side effects or adverse events. The total participation time varies, with key assessments occurring around 16 to 24 weeks and safety monitored for about a year.
CONDITIONS
Brief 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 for serum acetylcholine receptor antibody or MUSK antibody during screening
- MG-ADL score of 5 or higher at screening and baseline
- Stable dose of standard care treatment for generalized myasthenia gravis before randomization and throughout the study
- Agreement to use effective contraception from consent signing to 1 year after last dose, including negative pregnancy test for fertile females before first dose
You will not qualify if you...
- MGFA classification type I or V
- Use of prescribed drugs that interfere with the study
- Presence or history of other diseases that affect eligibility
- Abnormal examination results assessed as unsuitable by the investigator
- Known severe allergic reaction to humanized monoclonal antibodies or any component of B007
- Receipt of live vaccines within specified times before or after dosing
- Major surgery or participation in other clinical trials within specified times before screening
- Pregnant or breastfeeding women
- Fertile females unwilling to use contraception from consent to 1 year after last dose
- Sexually active males unwilling to use contraception during the trial and 1 year after last dose or planning to donate sperm
- History of alcohol or drug abuse within past 12 months
- Other conditions deemed unsuitable by researchers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 16 weeks
Participants receive subcutaneous injections of B007 or placebo on days 1 and 15.
2 visits for injections plus follow-up visits during treatment period
Duration - Up to 1 year
Participants are monitored for safety and efficacy outcomes after treatment ends.
Periodic visits for safety monitoring
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
H
Huan Yang
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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