NCT05728684

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2023

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 17, 2023

Completed
29 days until next milestone

First Posted

Study publicly available on registry

February 15, 2023

Completed
13 days until next milestone

Study Start

First participant enrolled

February 28, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2024

Completed
Last Updated

February 15, 2023

Status Verified

February 1, 2023

Enrollment Period

1 year

First QC Date

January 17, 2023

Last Update Submit

February 13, 2023

Conditions

IgG4 Related Disease

Outcome Measures

Primary Outcomes (1)

  • Response rate

    Response rate after administration for 12 weeks

    up to week 12

Study Arms (1)

CM310

EXPERIMENTAL

CM310, subcutaneous

Biological: CM310

Interventions

CM310BIOLOGICAL

CM310 Injection

CM310

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥18 years, male and female.
  • With IGG4-related disease.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Immunoglobulin G4-Related Disease

Condition Hierarchy (Ancestors)

Autoimmune DiseasesImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy Director of Rheumatology Department

Study Record Dates

First Submitted

January 17, 2023

First Posted

February 15, 2023

Study Start

February 28, 2023

Primary Completion

February 28, 2024

Study Completion

February 28, 2024

Last Updated

February 15, 2023

Record last verified: 2023-02