Looking for blood and saliva markers of mepolizumab response in EGPA
Studies protein markers of organ damage and mepolizumab response in adults with EGPA.
Key facts
- Who runs it
- Azienda Ospedaliero Universitaria di Cagliari
- Where
- Cagliari, ItalySee the site
- Trial code
- Registry title
- Beyond EOsinophils: proteoMICS to Identify Potential Biomarker of Organ Damage and Response to MEPOLIZUMAB in EGPA
- Status
- Enrolling by invitation
- Phase
- Phase 4
- People taking part
- 90 people, planned
- Started
- 17 Oct 2025
- Expected to end
- 30 Sept 2028
- Type of study
- Interventional, 3 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Mepolizumab 100 MG Injection [Nucala]
- Mepolizumab 300 mg
- Record updated
- 15 January 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with EGPA or asthma whose doctor has decided to start mepolizumab. Blood, saliva and sputum samples will be studied.
- Age
- 18 years or older
- Sex
- All
- Disease stage
- A current clinical diagnosis of asthma or EGPA.
- Earlier treatment
- Must have taken a medium-high dose inhaled steroid (ICS) plus another controller for at least 6 months before screening. If on oral steroids, the dose must be stable for 4 weeks before screening. The doctor must have decided to start mepolizumab.
Main reasons for not taking part
- Asthma patients receiving another biological treatment
- Took part in an interventional trial with a set treatment or monitoring plan in the previous 12 months
- Pregnant or breastfeeding women
The registry criteria, word for word
Show all 8 criteriaShow less
Who can take part
- Informed Consent: Prior to start any study related activities, participants must be able and willing to provide written informed consent
- Participants must have a current clinical diagnosis of asthma or EGPA
- Physician decision to initiate treatment with mepolizumab
- Patient has to be in treatment with medium-high dose ICS plus an additional controller in the least 6 months before screening and, if on OCS therapy, a stable dosage of prednisone (or equivalent dose of other steroids) in the 4 weeks before screening will be allowed. The above-indicated treatment has to be maintained by the patient all along the study
- Adults aged 18 years or over
Who cannot take part
- Asthmatic patients receiving other biological treatment
- Participation in an interventional clinical trial in which the treatment regimen and/or monitoring is dictated by a protocol during the previous 12 months
- Pregnant and breastfeeding woman
Where in Italy
- Policlinico Duilio Casula AOU CagliariCagliari, ItalyNo longer taking part
About the trial
What the trial wants to find out
Aim of the study is to identify potential biomarkers, through a proteomic approach, which could be used to evaluate organ damage and predict the response to mepolizumab in a cohort of patients affected by EGPA. Proteomic analyses will be performed using a proteomic platform, based on a nano-HPLC- couplet to an high resolution ESI-MS device, on three types of biological matrices: blood, saliva and sputum samples in both EGPA and severe asthmatic patients (as controls) at baseline and at different time points after starting treatment with mepolizumab, an anti-IL-5 drug, in order to cluster patients and to analyze the effect of the therapy during treatment, assessing the disease progression on three key aspects: lung function and symptoms control, vasculitis and neuropathy. Plasma analysis will provide an overview of quantitative/qualitative proteomic variations at systemic level after drug administration; however, a less invasive procedure is often sufficient and would improve trial recruitment. On this regard, saliva is a biological fluid well suitable to be used in proteomic investigations for suggestion of potential disease biomarkers and includes various potential advantages compared with blood sample collection such as lower overall cost, lower infection risk, increased patient convenience, acceptability, compliance and uptake. Moreover, the protein composition of the human saliva includes both specific proteins of the oral cavity and proteins common to other tissues and bodily fluids, so saliva prognostic and diagnostic role is particularly interesting. Consequently, the plan is to compare the proteomic results of the non-invasive saliva testing to that of blood examination.
Read full original descriptionShow less
These data may be a further step to untangle the mechanisms of the disease and to characterize treatment's response, in the contest of a phenotype/endotype asthma management.
The 3 groups in the trial
- EGPA with predominant ENT/asthmatic phenotypeTreatment being tested
Mepolizumab treatment
Treatment: Mepolizumab 300 mg
- EGPA with vasculitic phenotypeTreatment being tested
immunosuppressive drugs (CYC, AZA, MTX) and/or Mepolizumab
Treatment: Mepolizumab 300 mg
- severe eosinophilic asthmaExisting treatment, for comparison
before and after Mepolizumab treatment
Treatment: Mepolizumab 100 MG Injection [Nucala]
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Beyond Eosinophils: Proteomics to Identify Potential Biomarkers of Organ Damage and Response to MEPOLIZUMAB in EGPA
- Plain-language title
- Looking for blood and saliva markers of mepolizumab response in EGPAGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 13 November 2026.
- Record updated
- 15 January 2026