Recruiting NCT06454357

A Clinical Study of B007 in the Treatment of Pemphigus.

Phase II / Phase III Interventional Pemphigus

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: B007.
Who it may be relevant to: Registry conditions: Pemphigus. Basic parameters: 18 years — 75 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: China
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Official title

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

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

Drug B007
B007：high dose/low dose: Subcutaneous injection was administered on days 1 and 15

Proportion of subjects：Complete remission with minimal treatment [Time frame: Approximately36 weeks]

Secondary outcome measures (6)

The number of relapses of the disease [Time frame: Approximately 1 years]
Proportion of subjects：Partial remission [Time frame: Approximately 36weeks]
Change: PDAI（Pemphigus disease area index） [Time frame: Approximately 36 weeks]
CR/PR Proportion of subjects：Complete remission /Partial remission [Time frame: Approximately 52 weeks]
DoR （Duration of Response） [Time frame: Approximately 1 years]
Incidence of Treatment-Emergent Adverse Events [Time frame: Approximately 1 years]

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;
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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

China · 12 centers

NCT: NCT06454357 · SPH-B007-304