Study to Evaluate the Efficacy and Safety of CM310 in Subjects With IgG4-related Disease
Sponsor
Beijing Friendship Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05728684
Collaborator
(none)
20
1
12
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
This study includes three stages: screening period, treatment period and safety follow-up period.
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Anticipated Study Start Date
:
Feb 28, 2023
Anticipated Primary Completion Date
:
Feb 28, 2024
Anticipated Study Completion Date
:
Feb 28, 2024
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: CM310 CM310, subcutaneous |
Biological: CM310
CM310 Injection
|
Outcome Measures
Primary Outcome Measures
- Response rate [up to week 12]
Response rate after administration for 12 weeks
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Beijing Friendship Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Liu Yanying,
Deputy Director of Rheumatology Department,
Beijing Friendship Hospital
ClinicalTrials.gov Identifier:
NCT05728684
Other Study ID Numbers:
- YYXSSC-IIT-002
First Posted:
Feb 15, 2023
Last Update Posted:
Feb 15, 2023
Last Verified:
Feb 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: