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Adaptive and Trained Immunity in the Pathogenesis of IgG4-Related Disease | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITING

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

Identification of Adaptive and Trained Immune Mechanisms Driving Tissue Fibrosis in IgG4-Related Disease

NCT06844864•IRCCS San Raffaele

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

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

Locations (1)

Ospedale San Raffaele

Milan, MI, Italy

Key Dates

Start Date

March 1, 2025

Primary Completion Date

September 1, 2025

Completion Date

September 1, 2025

Last Updated

April 30, 2025

Enrollment

ESTIMATED participants

Conditions

IgG4 Related Disease

Study to Assess Safety, Efficacy and Persistence of ACE1831, in Subjects With IgG4-Related Disease

NCT07061938

IgG4 Related Disease

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RECRUITINGEARLY_PHASE1

the Safety and Efficacy of Targeted BCMA In Vivo LV Injection for Recurrent or Refractory Autoimmune Diseases

NCT07339540

Recurrent or Refractory Systemic Lupus ErythematosusRecurrent or Refractory IgG4 Related Diseases+3 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 30, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Study to Assess Safety, Efficacy and Persistence of ACE1831, in Subjects With IgG4-Related Disease

the Safety and Efficacy of Targeted BCMA In Vivo LV Injection for Recurrent or Refractory Autoimmune Diseases

A Study of Inebilizumab Efficacy and Safety in IgG4- Related Disease