Trial Title:
A Clinical Study of B007 in the Treatment of Generalized Myasthenia Gravis.
NCT ID:
NCT06447597
Condition:
Generalized Myasthenia Gravis
Conditions: Official terms:
Myasthenia Gravis
Muscle Weakness
Study type:
Interventional
Study phase:
Phase 2/Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Double (Participant, Investigator)
Intervention:
Intervention type:
Drug
Intervention name:
B007
Description:
B007 high dose and low dose： Subcutaneous injection was administered on days 1 and 15
Arm group label:
B007
Intervention type:
Drug
Intervention name:
Placebo
Description:
B007 matched Placebo Subcutaneous injection was administered on days 1 and 15
Arm group label:
Placebo
Summary:
The purpose of this study is to evaluate the efficacy and safety of B007 in subjects with
generalized myasthenia gravis.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Peking University First Hospital
Address:
City:
Beijing
Country:
China
Status:
Recruiting
Contact:
Last name:
Feng Gao
Facility:
Name:
The First Bethune Hospital of Jilin University
Address:
City:
Changchun
Country:
China
Status:
Recruiting
Contact:
Last name:
Hui Deng
Facility:
Name:
Xiangya Hospital Central South University
Address:
City:
Changsha
Country:
China
Status:
Recruiting
Contact:
Last name:
Huan yang
Facility:
Name:
Sichuan Provincial People's Hospital
Address:
City:
Chengdu
Country:
China
Status:
Recruiting
Contact:
Last name:
Fei Xu
Facility:
Name:
Nanfang Hospital, Southern Medical University
Address:
City:
Guangzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Haishan Jiang
Facility:
Name:
The First Affiliated Hospital, Zhejiang University School of Medicine
Address:
City:
Hangzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Qing Ke
Facility:
Name:
Shandong Provincial Qianfoshan Hospital
Address:
City:
Jinan
Country:
China
Status:
Recruiting
Contact:
Last name:
Ruisheng Duan
Facility:
Name:
Shandong University Cheeloo College of Medicine
Address:
City:
Jinan
Country:
China
Status:
Recruiting
Contact:
Last name:
Wei Li
Facility:
Name:
First People's Hospital of Yunnan Province
Address:
City:
Kunming
Country:
China
Status:
Recruiting
Contact:
Last name:
Qiang Meng
Facility:
Name:
Jiangxi Provincial People's Hospital
Address:
City:
Nanchang
Country:
China
Status:
Recruiting
Contact:
Last name:
Rensi Xu
Facility:
Name:
The Second Affiliated Hospital of Nanchang University
Address:
City:
Nanchang
Country:
China
Status:
Recruiting
Contact:
Last name:
Jianglong Tu
Facility:
Name:
Shandong University Cheeloo College of Medicine
Address:
City:
Qingdao
Country:
China
Status:
Recruiting
Contact:
Last name:
Cuiping Zhao
Facility:
Name:
Huashan Hospital, Fudan University
Address:
City:
Shanghai
Country:
China
Status:
Recruiting
Contact:
Last name:
jianying Xi
Facility:
Name:
Shenzhen Hospital of University of Hong Kong
Address:
City:
Shenzhen
Country:
China
Status:
Recruiting
Contact:
Last name:
Haibing Xiao
Facility:
Name:
Renmin Hospital of Wuhan University
Address:
City:
Wuhan
Country:
China
Status:
Recruiting
Contact:
Last name:
Zuneng Lu
Facility:
Name:
Tongji Medical College of HUST
Address:
City:
Wuhan
Country:
China
Status:
Recruiting
Contact:
Last name:
Bitao Bu
Facility:
Name:
Tangdu Hospital
Address:
City:
Xi'an
Country:
China
Status:
Recruiting
Contact:
Last name:
Ting Chang
Facility:
Name:
Affiliated Hospital of Zunyi Medical College
Address:
City:
Zunyi
Country:
China
Status:
Recruiting
Contact:
Last name:
Zucai Xu
Start date:
July 1, 2024
Completion date:
June 30, 2026
Lead sponsor:
Agency:
Shanghai Jiaolian Drug Research and Development Co., Ltd
Agency class:
Industry
Collaborator:
Agency:
Shanghai Pharmaceuticals Holding Co., Ltd
Agency class:
Industry
Source:
Shanghai Jiaolian Drug Research and Development Co., Ltd
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06447597
