A Clinical Study of B007 in the Treatment of Pemphigus.
A Phase II/III Clinical Study to Evaluate the Efficacy and Safety of B007 in Subjects With Pemphigus.
1 other identifier
interventional
132
1 country
12
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of B007 in subjects with pemphigus.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2024
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 6, 2024
CompletedFirst Posted
Study publicly available on registry
June 12, 2024
CompletedStudy Start
First participant enrolled
July 12, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
May 5, 2026
April 1, 2026
2.5 years
June 6, 2024
April 29, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Proportion of subjects：Complete remission with minimal treatment
Approximately36 weeks
Secondary Outcomes (6)
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
- +1 more secondary outcomes
Study Arms (1)
B007
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
Peking University First Hospital
Beijing, China
The Second Xiangya Hospital of Central South University
Changsha, China
Chengdu Second People's Hospital
Chengdu, China
West China Hospital, Sichuan University
Chengdu, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, China
Dermatology Hospital of Southern Medical University
Guangzhou, China
Guangdong Provincial People's Hospital
Guangzhou, China
Shandong First Medical University-Affiliated Skin Hospital
Jinan, China
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China
Henan Provincial People's Hospital
Zhengzhou, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 6, 2024
First Posted
June 12, 2024
Study Start
July 12, 2024
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
May 5, 2026
Record last verified: 2026-04