A Clinical Study of B007 in the Treatment of Pemphigus.

Phase 2

Recruiting

• Conditions: Pemphigus
• Interventions: Drug: B007

• Registration Number: NCT06454357
• Lead Sponsor: Shanghai Jiaolian Drug Research and Development Co., Ltd

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-06
• Study First Submitted: 2024-06-06
• Study First Submitted QC: 2024-06-06
• Study First Posted: 2024-06-12
• Study Start: 2024-07-12
• Last Update Submitted: 2024-10-09
• Last Update Posted: 2024-10-10
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 132

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.

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
B007	B007	-

Primary Outcome Measures

Name	Time	Method
Proportion of subjects：Complete remission with minimal treatment	Approximately36 weeks

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Peking University First Hospital; 🇨🇳 Beijing, China