Study to Evaluate the Efficacy and Safety of CM310 in Sub... | NCT05728684

Studies
Study to Evaluate the Efficacy and Safety of CM310 in Subjects With IgG4-related Disease

NCT05728684

Sponsor

Beijing Friendship Hospital

Status

Unknown status

Last Update Posted

Feb 15, 2023Actual

Enrollment

20Estimated

Phase

Not Applicable

Conditions

IgG4 Related Disease

Interventions

CM310

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 28, 2023Estimated

Primary Completion Date

Feb 28, 2024Estimated

Completion Date

Feb 28, 2024Estimated

First Submitted Date

Jan 17, 2023

First Submission Date that Met QC Criteria

Feb 13, 2023

First Posted Date

Feb 15, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 13, 2023

Last Update Posted Date

Feb 15, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Liu Yanying, Deputy Director of Rheumatology Department, Beijing Friendship HospitalPrincipal Investigator

Lead Sponsor

Beijing Friendship HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CM310	Experimental	CM310, subcutaneous	Biological: CM310

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CM310	Biological	CM310 Injection	CM310

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Response rate	Response rate after administration for 12 weeks	up to week 12

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000077733	Immunoglobulin G4-Related Disease

Ancestor Terms

ID	Term
D001327	Autoimmune Diseases
D007154	Immune System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided