Clinical trial NCT06454357: A Clinical Study of B007 in the Treatment of Pemphigus.
Official title: A Phase II/III Clinical Study to Evaluate the Efficacy and Safety of B007 in Subjects With Pemphigus.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Pemphigus
Lead sponsor: Shanghai Jiaolian Drug Research and Development Co., Ltd
Sponsor class: INDUSTRY
Collaborators: name: Shanghai Pharmaceuticals Holding Co., Ltd
First posted: 2024-06-12
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of B007 in subjects with pemphigus.


Eligibility criteria: 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 outcomes:
measure: Proportion of subjects：Complete remission with minimal treatment
timeFrame: Approximately36 weeks
Secondary outcomes:
measure: The number of relapses of the disease
timeFrame: Approximately 1 years
measure: Proportion of subjects：Partial remission
timeFrame: Approximately 36weeks
measure: Change: PDAI（Pemphigus disease area index）
timeFrame: Approximately 36 weeks
measure: CR/PR Proportion of subjects：Complete remission /Partial remission
timeFrame: Approximately 52 weeks
measure: DoR （Duration of Response）
timeFrame: Approximately 1 years
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: Approximately 1 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
city: Chengdu
country: China
facility: Chengdu Second People's Hospital
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqing Medical University
city: Fuzhou
country: China
facility: The First Affiliated Hospital of Fujian Medical University
city: Guangzhou
country: China
facility: Dermatology Hospital of Southern Medical University
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
city: Jinan
country: China
facility: Shandong First Medical University-Affiliated Skin Hospital
city: Shanghai
country: China
facility: Ruijin Hospital, Shanghai Jiaotong University School of Medicine
city: Wuhan
country: China
facility: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
city: Zhengzhou
country: China
facility: Henan Provincial People's Hospital
Study officials:
References: