Evaluating B007 for treating pemphigus

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Study coordinator: Hang Li
• Email: bdyyec@163.com
• Phone: 0086-010-66119025

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Treatment of Primary Membranous Nephropathy with B007

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• Treatment of Neuromyelitis Optica Spectrum Disorders with B001 Injection

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.