Clinical trial NCT06447597: A Clinical Study of B007 in the Treatment of Generalized Myasthenia Gravis.
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Generalized Myasthenia Gravis
Lead sponsor: Shanghai Jiaolian Drug Research and Development Co., Ltd
Sponsor class: INDUSTRY
Collaborators: name: Shanghai Pharmaceuticals Holding Co., Ltd
First posted: 2024-06-07
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of B007 in subjects with generalized myasthenia gravis.


Eligibility criteria: 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 outcomes:
measure: Proportion of subjects：MG-ADL（Myasthenia gravis-activities of daily living profile） decreased by ≥2
timeFrame: Approximately 16 weeks
Secondary outcomes:
measure: Proportion of subjects：subjects without SoC（Standard of Care） change and MG-ADL decreased by ≥2
timeFrame: Approximately 24 weeks
measure: Proportion of subjects：subjects without SoC change and QMG(Quantitative Myasthenia Gravis score) decreased by ≥3
timeFrame: Approximately 24 weeks
measure: Changes in MGQoL15r (Myasthenia gravis quality of life15-item revised) from baseline.
timeFrame: Approximately 24 weeks
measure: Changes in MGC (Myasthenia gravis composite) from baseline.
timeFrame: Approximately 24 weeks
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: Approximately 1 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
city: Changchun
country: China
facility: The First Bethune Hospital of Jilin University
city: Changsha
country: China
facility: Xiangya Hospital Central South University
city: Chengdu
country: China
facility: Sichuan Provincial People's Hospital
city: Guangzhou
country: China
facility: Nanfang Hospital, Southern Medical University
city: Hangzhou
country: China
facility: The First Affiliated Hospital, Zhejiang University School of Medicine
city: Jinan
country: China
facility: Shandong Provincial Qianfoshan Hospital
city: Jinan
country: China
facility: Shandong University Cheeloo College of Medicine
city: Kunming
country: China
facility: First People's Hospital of Yunnan Province
city: Nanchang
country: China
facility: Jiangxi Provincial People's Hospital
city: Nanchang
country: China
facility: The Second Affiliated Hospital of Nanchang University
city: Qingdao
country: China
facility: Shandong University Cheeloo College of Medicine
city: Shanghai
country: China
facility: Huashan Hospital, Fudan University
city: Shenzhen
country: China
facility: Shenzhen Hospital of University of Hong Kong
city: Wuhan
country: China
facility: Renmin Hospital of Wuhan University
city: Wuhan
country: China
facility: Tongji Medical College of HUST
city: Xi'an
country: China
facility: Tangdu Hospital
city: Zunyi
country: China
facility: Affiliated Hospital of Zunyi Medical College
Study officials:
References: