IgG4 Related Disease Clinical Trial
Official title:
A Single-arm Study Sponsored by Investigators to Evaluate the Efficacy and Safety of CM310 Recombinant Humanized Monoclonal Antibody Injection in Patients With Recurrent IgG4-related Diseases
Verified date | February 2023 |
Source | Beijing Friendship Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study is a single-arm study initiated to evaluate the efficacy and safety of CM310 in subjects with recurrent IgG4-related disease.
Status | Not yet recruiting |
Enrollment | 20 |
Est. completion date | February 28, 2024 |
Est. primary completion date | February 28, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - =18 years, male and female. - With IGG4-related disease. Exclusion Criteria: - Inoculate live vaccine within 4 weeks before screening. - Treponema pallidum antibody positive in screening period. - Active hepatitis in screening period. - With a history of solid organ or cell transplantation within 6 months before screening. - With other medical or non-medical conditions that are not suitable for the study by the investigator. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Beijing Friendship Hospital |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Response rate | Response rate after administration for 12 weeks | up to week 12 |
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