RecruitingPhase 2/3

A Clinical Study of B007 in the Treatment of Pemphigus.

China132 participantsStarted 2024-07-12

Plain-language summary

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

Age range18 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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;

Proportion of subjects：Complete remission with minimal treatment

Timeframe: Approximately36 weeks

NCT IDNCT06454357

SponsorShanghai Jiaolian Drug Research and Development Co., Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-12-31

Hang Li