Evaluating B007 for treating pemphigus

A Phase II/III Clinical Study to Evaluate the Efficacy and Safety of B007 in Subjects With Pemphigus.

This study is testing a new treatment called B007 to see if it helps people with pemphigus feel better and stay healthy.

Quick facts

• Phase: PHASE2; PHASE3
• Study type: Interventional
• Enrollment: 132 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Shanghai Jiaolian Drug Research and Development Co., Ltd (industry)
• Locations: 12 sites (Beijing and 11 other locations)
• Trial ID: NCT06454357 on ClinicalTrials.gov

What this trial studies

This clinical study aims to assess the efficacy and safety of B007 in patients diagnosed with pemphigus. It includes participants who are either newly diagnosed or experiencing a relapse of the condition. The study will follow a structured protocol to ensure that eligible subjects receive the treatment while monitoring their health outcomes. The research is being conducted in multiple locations to gather diverse data on the treatment's effectiveness.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals who have been clinically diagnosed with pemphigus and are either newly diagnosed or experiencing a relapse.

Not a fit: Patients with a disease duration exceeding four years or those with certain specified diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the management of pemphigus, offering patients a new therapeutic option.

How similar studies have performed: While this approach is being evaluated in this study, similar interventions have shown promise in treating autoimmune conditions, suggesting potential for success.

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.

Where this trial is running

Beijing and 11 other locations

• Peking University First Hospital — Beijing, China (RECRUITING)
• The Second Xiangya Hospital of Central South University — Changsha, China (RECRUITING)
• Chengdu Second People's Hospital — Chengdu, China (RECRUITING)
• West China Hospital, Sichuan University — Chengdu, China (RECRUITING)
• The First Affiliated Hospital of Chongqing Medical University — Chongqing, China (RECRUITING)
• The First Affiliated Hospital of Fujian Medical University — Fuzhou, China (RECRUITING)
• Dermatology Hospital of Southern Medical University — Guangzhou, China (RECRUITING)
• Guangdong Provincial People's Hospital — Guangzhou, China (RECRUITING)
• Shandong First Medical University-Affiliated Skin Hospital — Jinan, China (RECRUITING)
• Ruijin Hospital, Shanghai Jiaotong University School of Medicine — Shanghai, China (RECRUITING)
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, China (RECRUITING)
• Henan Provincial People's Hospital — Zhengzhou, China (RECRUITING)

Study contacts

• Study coordinator: Hang Li

Conditions: Pemphigus