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Long-Term Safety and Effectiveness of Mepolizumab 300 mg in Europe (Mepo LTF Study)

NCT07591753 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 591

Last updated 2026-05-18

No results posted yet for this study

Summary

This observational study aims to evaluate the long-term effectiveness and safety of mepolizumab 300 mg/4 weeks in adults with eosinophilic granulomatosis with polyangiitis (EGPA) in the European real-life setting.

The main questions it aims to answer are:

* How effective is mepolizumab 300 mg/4 weeks over long-term follow-up in patients with EGPA?
* How safe is mepolizumab 300 mg/4 weeks during long-term treatment?
* What are the effects of switching mepolizumab dosage from 300 mg/4 weeks to 100 mg/4 weeks, or from 100 mg/4 weeks to 300 mg/4 weeks?

Participants already receiving mepolizumab as part of routine clinical practice. Researchers will retrospectively collect demographic, clinical, laboratory, and treatment-related data from medical records. For patients starting mepolizumab 300 mg/4 weeks, data will be collected from treatment initiation and during follow-up up to 60 months. For patients who change mepolizumab dose, data will also be collected at the time of dose switch and 3 months later.

Conditions

  • Eosinophilic Granulomatosis With Polyangiitis (Churg-Strauss) (EGPA)

Interventions

BIOLOGICAL

Mepolizumab 300 mg

Mepolizumab administered subcutaneously at a dose of 300 mg every 4 weeks in routine clinical practice for adult patients with eosinophilic granulomatosis with polyangiitis (EGPA). In this retrospective observational study, patients may receive mepolizumab 300 mg/4 weeks as the initial regimen or after dose escalation from 100 mg/4 weeks. Dose changes from 300 mg/4 weeks to 100 mg/4 weeks, or from 100 mg/4 weeks to 300 mg/4 weeks, are also evaluated when they occur during routine care; no study-specific treatment is assigned.

Sponsors & Collaborators

  • GlaxoSmithKline

    collaborator INDUSTRY

  • European EGPA Study Group

    lead NETWORK

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-18
Primary Completion
2026-03-31
Completion
2026-03-31

Countries

  • Italy

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07591753 on ClinicalTrials.gov