A Clinical Study of B007 in the Treatment of Pemphigus.

Pemphigus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06454357
• Other study ID #: SPH-B007-304
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• Start date: June 30, 2024
• Est. completion date: December 31, 2026

Study information

• Verified date: June 2024
• Source: Shanghai Jiaolian Drug Research and Development Co., Ltd
• Contact: Hang Li
• Phone: 0086-010-66119025
• Email: bdyyec[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 132
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pemphigus

Intervention

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

Locations

Country	Name	City	State
China	Peking University First Hospital	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai Jiaolian Drug Research and Development Co., Ltd	Shanghai Pharmaceuticals Holding Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects:Complete remission with minimal treatment		Approximately36 weeks
Secondary	The number of relapses of the disease		Approximately 1 years
Secondary	Proportion of subjects:Partial remission		Approximately 36weeks
Secondary	Change: PDAI(Pemphigus disease area index)		Approximately 36 weeks
Secondary	CR/PR Proportion of subjects:Complete remission /Partial remission		Approximately 52 weeks
Secondary	DoR (Duration of Response)		Approximately 1 years
Secondary	Incidence of Treatment-Emergent Adverse Events		Approximately 1 years