Clinical Trials in China / NCT06447597
Recruiting
Phase 2/3
A Clinical Study of B007 in the Treatment of Generalized Myasthenia Gravis.
NCT06447597 · tracked via the Priya Life Science China tracker
Condition(s) studied
Generalized Myasthenia Gravis
Investigational drug(s) / intervention(s)
B007 →Placebo
B007: B007 high dose and low dose: Subcutaneous injection was administered on days 1 and 15
Placebo: B007 matched Placebo Subcutaneous injection was administered on days 1 and 15
Study summary
The purpose of this study is to evaluate the efficacy and safety of B007 in subjects with generalized myasthenia gravis.
Eligibility
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.
Primary outcome measure(s)
- Proportion of subjects:MG-ADL(Myasthenia gravis-activities of daily living profile) decreased by ≥2 — Approximately 16 weeks
Proportion of subjects:MG-ADL decreased by ≥2
Trial sites (18)
| Facility | City | Region | Status |
|---|---|---|---|
| Peking University First Hospital | Beijing | China | Recruiting |
| The First Bethune Hospital of Jilin University | Changchun | China | Recruiting |
| Xiangya Hospital Central South University | Changsha | China | Recruiting |
| Sichuan Provincial People's Hospital | Chengdu | China | Recruiting |
| Nanfang Hospital, Southern Medical University | Guangzhou | China | Recruiting |
| The First Affiliated Hospital, Zhejiang University School of Medicine | Hangzhou | China | Recruiting |
| Shandong Provincial Qianfoshan Hospital | Jinan | China | Recruiting |
| Shandong University Cheeloo College of Medicine | Jinan | China | Recruiting |
| First People's Hospital of Yunnan Province | Kunming | China | Recruiting |
| Jiangxi Provincial People's Hospital | Nanchang | China | Recruiting |
| The Second Affiliated Hospital of Nanchang University | Nanchang | China | Recruiting |
| Shandong University Cheeloo College of Medicine | Qingdao | China | Recruiting |
| Huashan Hospital, Fudan University | Shanghai | China | Recruiting |
| Shenzhen Hospital of University of Hong Kong | Shenzhen | China | Recruiting |
| Renmin Hospital of Wuhan University | Wuhan | China | Recruiting |
| Tongji Medical College of HUST | Wuhan | China | Recruiting |
| Tangdu Hospital | Xi'an | China | Recruiting |
| Affiliated Hospital of Zunyi Medical College | Zunyi | China | Recruiting |
More Shanghai Jiaolian Drug Research and Development Co., Ltd trials in China
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A Phase 3 Study to Evaluate the Efficacy and Safety of Efgartigimod IV in Patients With Acetylcholine Receptor Binding Antibody Seronegative Generalized Myasthenia Gravis
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06447597 on ClinicalTrials.gov ↗ ← All trials in China