Back to resultsStudy to Evaluate the Efficacy and Safety of CM310 in Subjects With IgG4-related Disease
Primary Purpose
IgG4 Related Disease
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
CM310
Sponsored by
About this trial
This is an interventional treatment trial for IgG4 Related Disease
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CM310
Arm Description
CM310, subcutaneous
Outcomes
Primary Outcome Measures
Response rate
Response rate after administration for 12 weeks
Secondary Outcome Measures
Full Information
NCT ID
NCT05728684
First Posted
January 17, 2023
Last Updated
February 13, 2023
Sponsor
Beijing Friendship Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05728684
Brief Title
Study to Evaluate the Efficacy and Safety of CM310 in Subjects With IgG4-related Disease
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 28, 2023 (Anticipated)
Primary Completion Date
February 28, 2024 (Anticipated)
Study Completion Date
February 28, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Friendship Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This study is a single-arm study initiated to evaluate the efficacy and safety of CM310 in subjects with recurrent IgG4-related disease.
Detailed Description
This study includes three stages: screening period, treatment period and safety follow-up period.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
IgG4 Related Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CM310
Arm Type
Experimental
Arm Description
CM310, subcutaneous
Intervention Type
Biological
Intervention Name(s)
CM310
Intervention Description
CM310 Injection
Primary Outcome Measure Information:
Title
Response rate
Description
Response rate after administration for 12 weeks
Time Frame
up to week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
12. IPD Sharing Statement
Learn more about this trial
Study to Evaluate the Efficacy and Safety of CM310 in Subjects With IgG4-related Disease
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