Study of the C5a/C5aR1 Axis in IgG4-associated Disease: a Potential Therapeutic Target

Not Applicable

Not yet recruiting

• Conditions: Immunoglobulin G4-Related Disease

• Registration Number: NCT06270524
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

Brief Summary

This is a monocentric, comparative, cross-sectional, case-control study seeking to identify abnormalities of the C5a-C5aR1 axis between a population of patients with active IgG4-associated disease (MAG4) and two control groups: healthy subjects without MAG4 and patients with MAG4 in remission.

Detailed Description

IgG4-associated disease is a rare fibrosing and inflammatory disorder whose pathophysiology remains poorly understood. Activation of certain monocyte/macrophage populations (in particular M2-type macrophages) has been shown to be involved during the course of the disease. The mechanisms behind this monocyte/macrophage activation are not known. Expression of the C5aR receptor on the surface of these populations, and preliminary findings of elevated C5a in these patients, suggest a potential role for this C5a-C5aR axis. Demonstration of the involvement of this pathway would open a path to therapeutic perspetives (C5aR inhibitors) for these patients, who frequently suffer from cortico-dependence and relapses. The aim of this research is to use healthcare technologies to identify cellular and molecular therapeutic targets in the context of the IgG4-associated disease

Study Timeline

• Study First Submitted: 2024-02-14
• Study First Submitted QC: 2024-02-14
• Study First Posted: 2024-02-21
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-25
• Last Update Posted: 2024-06-26
• Study Start: 2024-09-01
• Primary Completion: 2026-09-01
• Study Completion: 2027-04-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Serum C5a concentration	24 months	The C5a concentration in the serum will be compared between of healthy volunteers and patients suffering from IG4-related disease

Secondary Outcome Measures

Name	Time	Method
frequency of C5aR1+ monocytes among total monocytes	24 months	The frequency of C5aR1+ monocytes among total monocytes will be compared between : * patients suffering from IG4-related disease and healthy volunteers; * patients suffering from IG4-related disease and patients in remission
frequency of Tumor Growth Factor B+ (TGF-B+) monocytes among total monocytes	24 months	frequency of Tumor Growth Factor B+ (TGF-B+) monocytes among total monocytesill be compared between : * patients suffering from IG4-related disease and healthy volunteers; * patients suffering from IG4-related disease and patients in remission