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| Name | Class |
|---|---|
| Shanghai Pharmaceuticals Holding Co., Ltd | INDUSTRY |
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The purpose of this study is to evaluate the efficacy and safety of B007 in subjects with pemphigus.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| B007 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| B007 | Drug | B007:high dose/low dose: Subcutaneous injection was administered on days 1 and 15 |
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects:Complete remission with minimal treatment | Approximately36 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The number of relapses of the disease | Approximately 1 years | |
| Proportion of subjects:Partial remission | Approximately 36weeks | |
| Change: PDAI(Pemphigus disease area index) |
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Inclusion Criteria:
Exclusion Criteria:
Subjects diagnosed with prescribed diseases;
Since the diagnosis of pemphigus, Disease duration>4 years;
Subjects using prescribed drugs;
Presence of a specified disease or history of disease;
The subjects has prescribed examination abnormalities that are assessed as unsuitable for participation in the study by the investigator;
A history of severe allergy or allergic reaction to human or mouse monoclonal antibodies; known contraindications to orally prescribed drugs;
Subjects who participate in another interventional clinical trial at a specified time before randomization;
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;
Pregnant and lactating women;
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;
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.
Other conditions deemed unsuitable for participation in this study by the researchers.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hang Li | Contact | 0086-010-66119025 | bdyyec@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University First Hospital | Recruiting | Beijing | China |
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| ID | Term |
|---|---|
| D010392 | Pemphigus |
| ID | Term |
|---|---|
| D012872 | Skin Diseases, Vesiculobullous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
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| Approximately 36 weeks |
| CR/PR Proportion of subjects:Complete remission /Partial remission | Approximately 52 weeks |
| DoR (Duration of Response) | Approximately 1 years |
| Incidence of Treatment-Emergent Adverse Events | Approximately 1 years |
| The Second Xiangya Hospital of Central South University | Recruiting | Changsha | China |
|
| Chengdu Second People's Hospital | Recruiting | Chengdu | China |
|
| West China Hospital, Sichuan University | Recruiting | Chengdu | China |
|
| The First Affiliated Hospital of Chongqing Medical University | Recruiting | Chongqing | China |
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| The First Affiliated Hospital of Fujian Medical University | Recruiting | Fuzhou | China |
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| Dermatology Hospital of Southern Medical University | Recruiting | Guangzhou | China |
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| Guangdong Provincial People's Hospital | Recruiting | Guangzhou | China |
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| Shandong First Medical University-Affiliated Skin Hospital | Recruiting | Jinan | China |
|
| Ruijin Hospital, Shanghai Jiaotong University School of Medicine | Recruiting | Shanghai | China |
|
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Recruiting | Wuhan | China |
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| Henan Provincial People's Hospital | Recruiting | Zhengzhou | China |
|
| D007154 | Immune System Diseases |