A Clinical Study of B007 in the Treatment of Pemphigus.

Shanghai Jiaolian Drug Research and Development

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Pemphigus

Treatments: Drug: B007

Study type: Interventional

Funder types: Industry

Identifiers

NCT06454357

SPH-B007-304

Details and patient eligibility

About

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

Enrollment: 132 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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132 participants in 1 patient group

B007

Experimental group

Treatment:

Drug: B007