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Proteomics may unlock key clues to mepolizumab success in rare lung disease

NCT ID NCT07343661

Knowledge-focused Sponsor: Azienda Ospedaliero Universitaria di Cagliari Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study aims to find biological markers in blood, saliva, and sputum that can predict how well patients with EGPA (a rare inflammatory disease) and severe asthma respond to the drug mepolizumab. Researchers will analyze proteins in these samples before and after treatment to understand disease progression and treatment effects. The goal is to improve personalized care and potentially use less invasive saliva tests instead of blood draws.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Mepolizumab (Nucala)
What this could lead to
If successful, this could identify biomarkers to predict which patients will respond best to mepolizumab, improving personalized treatment for EGPA and severe asthma.
What could go wrong
This is an early-phase observational study focused on biomarkers, not a treatment trial. The findings may not lead to immediate clinical changes or benefit participants directly.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 90 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2025

Expected to finish

Sep 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: * 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

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Conditions

The condition(s) this trial relates to.

asthma chronic asthma eosinophilic granulomatosis with polyangiitis pulmonary eosinophilia T2-high asthma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Egpa - eosinophilic granulomatosis with polyangiitis Eosinophilic asthma Severe asthma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Policlinico Duilio Casula AOU Cagliari

    Cagliari, Cagliari, Italy

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