A Clinical Study of B007 in the Treatment of Generalized Myasthenia Gravis. (NCT06447597) | Clinical Trial Compass
RecruitingPhase 2/3
A Clinical Study of B007 in the Treatment of Generalized Myasthenia Gravis.
China104 participantsStarted 2024-07-01
Plain-language summary
The purpose of this study is to evaluate the efficacy and safety of B007 in subjects with generalized myasthenia gravis.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Exclusion criteria
. 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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of subjects：MG-ADL（Myasthenia gravis-activities of daily living profile） decreased by ≥2
Timeframe: Approximately 16 weeks
Trial details
NCT IDNCT06447597
SponsorShanghai Jiaolian Drug Research and Development Co., Ltd
. 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;