Shanghai Jiaolian Drug Research and Development Co., Ltd
Phase
Phase 2/3
Started
2024-07-12
Last updated
2026-05-05
Condition(s) studied
Pemphigus
Investigational drug(s) / intervention(s)
B007
B007: B007:high dose/low dose: 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 pemphigus.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
1. Subjects who voluntarily participate in this study and sign informed consent form;
2. Subjects who meet the clinical manifestations of pemphigus and are clinically diagnosed as prescribed diseases;
3. Subjects with first diagnosis or relapse;
4. Subjects who have the ability to follow the study protocol as determined by the investigator.
Exclusion Criteria:
1. Subjects diagnosed with prescribed diseases;
2. Since the diagnosis of pemphigus, Disease duration\>4 years;
3. Subjects using prescribed drugs;
4. Presence of a specified disease or history of disease;
5. The subjects has prescribed examination abnormalities that are assessed as unsuitable for participation in the study by the investigator;
6. A history of severe allergy or allergic reaction to human or mouse monoclonal antibodies; known contraindications to orally prescribed drugs;
7. Subjects who participate in another interventional clinical trial at a specified time before randomization;
8. 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;
9. Pregnant and lactating women;
10. Fertile female subjects do not agree to use effective contraception from signing the informed consent form to the prescribed time after the last dose.
Women who are considered fertile by the investigator must have negative serum pregnancy tests before starting the drug;
11. Sexually active male subjects who do not intend to use an effective contraceptive method during the trial period or within specified time after the last dose, or male subjects who plan to donate sperm at a specified time during the trial or after the last dose.
12. Other conditions deemed unsuitable for participation in this study by the researchers.
Primary outcome measure(s)
Proportion of subjects:Complete remission with minimal treatment — Approximately36 weeks
Trial sites (12)
Facility
City
Region
Status
Peking University First Hospital
Beijing
China
Recruiting
The Second Xiangya Hospital of Central South University
Changsha
China
Recruiting
Chengdu Second People's Hospital
Chengdu
China
Recruiting
West China Hospital, Sichuan University
Chengdu
China
Recruiting
The First Affiliated Hospital of Chongqing Medical University
Chongqing
China
Recruiting
The First Affiliated Hospital of Fujian Medical University
Fuzhou
China
Recruiting
Dermatology Hospital of Southern Medical University
Guangzhou
China
Recruiting
Guangdong Provincial People's Hospital
Guangzhou
China
Recruiting
Shandong First Medical University-Affiliated Skin Hospital
Jinan
China
Recruiting
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai
China
Recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan
China
Recruiting
Henan Provincial People's Hospital
Zhengzhou
China
Recruiting
More Shanghai Jiaolian Drug Research and Development Co., Ltd trials in China
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.
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