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
1 other identifier
interventional
104
1 country
18
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of B007 in subjects with generalized myasthenia gravis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jul 2024
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 3, 2024
CompletedFirst Posted
Study publicly available on registry
June 7, 2024
CompletedStudy Start
First participant enrolled
July 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2026
April 30, 2026
April 1, 2026
2 years
June 3, 2024
April 29, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Proportion of subjects：MG-ADL（Myasthenia gravis-activities of daily living profile） decreased by ≥2
Proportion of subjects：MG-ADL decreased by ≥2
Approximately 16 weeks
Secondary Outcomes (5)
Proportion of subjects：subjects without SoC（Standard of Care） change and MG-ADL decreased by ≥2
Approximately 24 weeks
Proportion of subjects：subjects without SoC change and QMG(Quantitative Myasthenia Gravis score) decreased by ≥3
Approximately 24 weeks
Changes in MGQoL15r (Myasthenia gravis quality of life15-item revised) from baseline.
Approximately 24 weeks
Changes in MGC (Myasthenia gravis composite) from baseline.
Approximately 24 weeks
Incidence of Treatment-Emergent Adverse Events
Approximately 1 years
Study Arms (2)
B007
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Sign informed consent form;
- Subjects with generalized myasthenia gravis;
- Serum AchR(Acetylcholine receptor)-Ab or MUSK-Ab was positive during screening;
- MG-ADL ≥5 at screening and baseline;
- Before randomization, subjects received at least one gMG stable dose of SoC, and maintain a stable dose throughout the test;
- 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.
You may not qualify if:
- Subjects with MGFA I and V type;
- Subjects usingprescribed drugs;
- Subjects with a prescribed disease or history of disease;
- The subjects has prescribed examination abnormalities that are assessed as unsuitable for participation in the study by the investigator;
- Known history of severe allergic reaction to humanized monoclonal antibodies, or known allergy to any component of B007;
- 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;
- Subjects who have received major surgery or participated in other clinical trials within the prescribed time before screening;
- Pregnant and lactating women;
- Fertile female subjects do not agree to use effective contraception from signing the informed consent form to 1 years after the last dose.
- 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;
- A history of alcohol or drug abuse within the past 12 months;
- Other conditions deemed unsuitable for participation in this study by the researchers.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 3, 2024
First Posted
June 7, 2024
Study Start
July 1, 2024
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
June 30, 2026
Last Updated
April 30, 2026
Record last verified: 2026-04