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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06231498
Other study ID # EPI-EGPA
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date April 2024
Est. completion date December 2025

Study information

Verified date February 2024
Source Meyer Children's Hospital IRCCS
Contact Augusto Vaglio, MD, PhD
Phone +39 0555662905
Email augusto.vaglio@meyer.it
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This is a case-control observational study on blood samples. The primary goal of this study is to identify the epigenetic marks that can distinguish patients suffering from Eosinophilic Granulomatosis with Polyangiitis (EGPA) from healthy individuals. The secondary goal is to identify epigenetic or transcriptional marks that can predict if a patient with EGPA will benefit from therapy with Mepolizumab. This study is observational, meaning there will be no alterations of patients' routine clinical care. A blood sample will be drawn for each patient. If the patient will undergo treatment with Mepolizumab (based on routine clinical care), then the blood sample will be drawn before Mepolizumab initiation. The blood samples will be used for genome-wide DNA methylation profiling and for transcriptomic profiling. Healthy individuals as controls for the association study will not be recruited. In fact, the epigenetic and transcriptomic data obtained from EGPA patient blood will be compared against already available genome-wide DNA methylation and transcriptomic profiles of the blood of healthy individuals from previous studies. A total of 300 patients with EGPA will be recruited for the study. The first part of the study, corresponding to the primary goal, will involve all of the 300 patients. The second part of the study, corresponding to the secondary goal, will involve a study population subset consisting of 50 patients.


Description:

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Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (3)

Lead Sponsor Collaborator
Meyer Children's Hospital IRCCS Careggi Hospital, University of Florence

Outcome

Type Measure Description Time frame Safety issue
Primary Epigenome-Wide Association Study The primary objective of the study is the identification of loci whose methylation level is associated with the pathology (i.e. epigenetic markers of the disease). This means that there is not any outcome that will be measured with regard to the primary objective. Through study completion, an average of 1 year
Primary Mepolizumab Therapy Response The main secondary objective of the study is the identification of loci whose methylation level correlates with the response to treatment with the Mepolizumab in patients with EGPA (i.e. epigenetic predictors of response to Mepolizumab). To this end, the response to treatment with Mepolizumab is the outcome that will be measured. Complete response to treatment will be de?ned as no disease activity (Birmingham Vasculitis Activity Score = 0) and a prednisolone or prednisone dose (or equivalent) of =4.0 mg/day, as de?ned by the MIRRA trial. Partial response to treatment will be de?ned as no disease activity and a prednisone dose (or equivalent) of >4.0 mg/day. 6 months and 12 months after Mepolizumab therapy initiation
See also
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