Pemphigus
Conditions
Brief summary
The purpose of this study is to evaluate the efficacy and safety of B007 in subjects with pemphigus.
Interventions
DRUGB007
B007：high dose/low dose: Subcutaneous injection was administered on days 1 and 15
Sponsors
Shanghai Jiaolian Drug Research and Development Co., Ltd
Shanghai Pharmaceuticals Holding Co., Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects：Complete remission with minimal treatment | Approximately36 weeks |
Secondary
| Measure | 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） | 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 |
Countries
China
Contacts
CONTACTHang Li
Outcome results
None listed