Tests B007 against placebo in generalized myasthenia gravis
Tests the drug B007 against a placebo in adults with generalized myasthenia gravis.
Plain-language title generated from the registry record
Registry title: A Clinical Study of B007 in the Treatment of Generalized Myasthenia Gravis.
Key facts
- Where
- Beijing, Changchun, Changsha, Chengdu, Guangzhou, Hangzhou, Jinan, Kunming, Nanchang, Qingdao, Shanghai, Shenzhen, Wuhan, Xi'an, and Zunyi, ChinaSee the 18 sites
- Phase
- Phase 2/3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Source: NCT06447597, who can take part
Where in China
- Peking University First HospitalBeijing, ChinaTaking people
- The First Bethune Hospital of Jilin UniversityChangchun, ChinaTaking people
- Xiangya Hospital Central South UniversityChangsha, ChinaTaking people
- Sichuan Provincial People's HospitalChengdu, ChinaTaking people
- Nanfang Hospital, Southern Medical UniversityGuangzhou, ChinaTaking people
- The First Affiliated Hospital Zhejiang University School of MedicineHangzhou, ChinaTaking people
- Shandong Provincial Qianfoshan HospitalJinan, ChinaTaking people
- Shandong University Cheeloo College of MedicineJinan, ChinaTaking people
- First People's Hospital of Yunnan ProvinceKunming, ChinaTaking people
- Jiangxi Provincial People's HospitalNanchang, ChinaTaking people
- The Second Affiliated Hospital of Nanchang UniversityNanchang, ChinaTaking people
- Shandong University Cheeloo College of MedicineQingdao, ChinaTaking people
- Huashan Hospital, Fudan UniversityShanghai, ChinaTaking people
- Shenzhen Hospital of University of Hong KongShenzhen, ChinaTaking people
- Renmin Hospital of Wuhan UniversityWuhan, ChinaTaking people
- Tongji Medical college of HUSTWuhan, ChinaTaking people
- Tangdu HospitalXi'an, ChinaTaking people
- Affiliated Hospital of Zunyi Medical CollegeZunyi, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Shanghai Jiaolian Drug Research and Development Co., Ltd
- Trial code
- NCT06447597
- Record updated
- 14 August 2026
- Original description
The purpose of this study is to evaluate the efficacy and safety of B007 in subjects with generalized myasthenia gravis.Read full original descriptionShow less
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
The purpose of this study is to evaluate the efficacy and safety of B007 in subjects with generalized myasthenia gravis.
Inclusion: 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: Subjects usingprescribed drugs; 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; Subjects with a prescribed disease or history of disease; Known history of severe allergic reaction to humanized monoclonal antibodies, or known allergy to any component of B007; A history of alcohol or drug abuse within the past 12 months; Other conditions deemed unsuitable for participation in this study by the researchers; Subjects with MGFA I and V type; The subjects has prescribed examination abnormalities that are assessed as unsuitable for participation in the study by the investigator; 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.