Status:
RECRUITING
A Clinical Study of B007 in the Treatment of Pemphigus.
Lead Sponsor:
Shanghai Jiaolian Drug Research and Development Co., Ltd
Collaborating Sponsors:
Shanghai Pharmaceuticals Holding Co., Ltd
Conditions:
Pemphigus
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
PHASE3
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of B007 in subjects with pemphigus.
Eligibility Criteria
Inclusion Criteria:
- Subjects who voluntarily participate in this study and sign informed consent form;
- Subjects who meet the clinical manifestations of pemphigus and are clinically diagnosed as prescribed diseases;
- Subjects with first diagnosis or relapse;
- Subjects who have the ability to follow the study protocol as determined by the investigator.
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;
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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.
Key Trial Info
Start Date :
July 12 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
132 Patients enrolled
Trial Details
Trial ID
NCT06454357
Start Date
July 12 2024
End Date
December 31 2026
Last Update
October 10 2024
Active Locations (12)
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1
Peking University First Hospital
Beijing, China
2
The Second Xiangya Hospital of Central South University
Changsha, China
3
Chengdu Second People's Hospital
Chengdu, China
4
West China Hospital, Sichuan University
Chengdu, China