IgG4 Related DiseaseTRIM4NCT06844864
Adaptive and Trained Immunity in the Pathogenesis of IgG4-Related Disease
An observational study of IgG4 Related Disease, run by IRCCS San Raffaele at 1 site in Italy.
Trial summary
Enquire involvement of trained immunity in the pathogenesis of IgG4RD Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- IgG4 Related Disease
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2025to Sep 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with IgG4-related disease and healthy controls
Who may be able to join
- 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
Who cannot join
- Patients and healthy controls:
- Subjects < 18 years of age
- Pregnant women
- Comorbidities (other ongoing active autoimmune diseases, ongoing cancer, ongoing infections)
- Ongoing immunosuppressive therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Identification of Adaptive and Trained Immune Mechanisms Driving Tissue Fibrosis in IgG4-Related Disease
Enquire involvement of trained immunity in the pathogenesis of IgG4RD
Read the 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.
- Conditions
- IgG4 Related Disease
- Keywords
- Trained immunity
- Medical subject headings
- Immunoglobulin G4-Related Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of collagen Ia in the supernant of macrophage/fibroblast co-cultures
Concentration of collagen Ia (ng/uL) in the supernant of macrophage/fibroblast co-cultures through ELISA assay
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2025
- Study start1 Mar 2025
- Primary completionSep 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IgG4 Related DiseaseStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emanuel Della Torre, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06844864
- Sponsor's protocol ID
- 2022FH5R92
- Other IDs
- 2022FH5R92
- Acronym
- TRIM4
- Status last verified
- Apr 2025
- First submitted
- 14 Feb 2025
- Last updated
- 30 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Adaptive and Trained Immune Mechanisms Driving Tissue Fibrosis in IgG4-Related Disease
- ClinicalTrials.gov ID
- NCT06844864
- Acronym / sponsor ID
- TRIM4 / 2022FH5R92
- Conditions
- IgG4 Related Disease
- Keywords
- Trained immunity
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 25 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with IgG4-related disease and healthy controls
Key inclusion criteria (8 listed)
- 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
- Adult subjects > or = 18 years of age
Key exclusion criteria (5 listed)
- Subjects < 18 years of age
- Pregnant women
- Comorbidities (other ongoing active autoimmune diseases, ongoing cancer, ongoing infections)
- Ongoing immunosuppressive therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Concentration of collagen Ia in the supernant of macrophage/fibroblast co-cultures
Time frame: 7 months
Concentration of collagen Ia (ng/uL) in the supernant of macrophage/fibroblast co-cultures through ELISA assay
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of IgG4 Related Disease, run by IRCCS San Raffaele at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 30 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of collagen Ia in the supernant of macrophage/fibroblast co-cultures (time frame: 7 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2025.