Adaptive and Trained Immunity in the Pathogenesis of IgG4-Related Disease

Active, not recruiting

• Conditions: IgG4 Related Disease

• Registration Number: NCT06844864
• Lead Sponsor: IRCCS San Raffaele

Brief Summary

Enquire involvement of trained immunity in the pathogenesis of IgG4RD

Detailed Description

Enquire involvement of trained immunity in the pathogenesis of IgG4RD using primary macrophages and co-cultures with patient derived fibroblasts. The investigators will first assess whether macrophages from patients are trained compared to macrophages of healthy controls and then challenge them with IgG from IgG4RD patients to evaluate the functional effects on cultivated fibroblasts.

Study Timeline

• Study First Submitted: 2025-02-14
• Study First Submitted QC: 2025-02-19
• Study First Posted: 2025-02-25
• Study Start: 2025-03-01
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-28
• Last Update Posted: 2025-04-30
• Primary Completion: 2025-09
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Patients:

• Adult subjects > or = 18 years of age
• Subjects capable of providing informed consent
• Active IgG4-RD based on the IgG4-related disease activity index
• Fulfillment of the 2019 ACR/EULAR Classification Criteria for IgG4RD

Healthy Controls:

• Adult subjects > or = 18 years of age
• Subjects capable of providing informed consent

Exclusion Criteria

Patients and healthy controls:

• Subjects < 18 years of age
• Pregnant women
• Comorbidities (other ongoing active autoimmune diseases, ongoing cancer, ongoing infections)
• Ongoing immunosuppressive therapy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Concentration of collagen Ia in the supernant of macrophage/fibroblast co-cultures	7 months	Concentration of collagen Ia (ng/uL) in the supernant of macrophage/fibroblast co-cultures through ELISA assay

Trial Locations

Locations (1)

Ospedale San Raffaele; 🇮🇹 Milan, MI, Italy