A Clinical Study of B007 in the Treatment of Pemphigus.

Launched by SHANGHAI JIAOLIAN DRUG RESEARCH AND DEVELOPMENT CO., LTD · Jun 6, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called B007 for people with pemphigus, a rare skin condition that causes painful blisters and sores. The goal is to see if B007 is safe and effective for patients who are newly diagnosed or experiencing a relapse of their condition. The trial is currently looking for volunteers aged 18 to 75 who have been diagnosed with pemphigus and can commit to following the study's guidelines.

Participants in the trial will need to sign a consent form to show they understand the study and want to take part. They should not have had pemphigus for more than four years, nor can they be taking certain medications or have specific health issues that might interfere with the study. Those who join will be closely monitored throughout the trial, and they can expect regular check-ins with the study team to assess their health and response to the treatment. It’s important for potential participants to be aware that women who can get pregnant and men who are sexually active will need to use effective contraception during the study.

Gender

ALL

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.