Benralizumab in EGPA: real-world effectiveness and safety
Official title: Benralizumab Effectiveness in the LONG-term Real-life Setting in EGPA: The BELONG-EGPA Study
Run by European EGPA Study Group · NCT07815886 · Data updated 2026-11-12
This is a real-world study checking how well and safely benralizumab works for adults with eosinophilic granulomatosis with polyangiitis (EGPA).
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | European EGPA Study Group Research network |
| Drugs / interventions | benralizumab, mepolizumab, prednisone |
| Locations | 1 site (Florence, Italy) |
| Status | Recruiting |
| Started | February 11, 2026 |
| Main results expected | February 11, 2027 |
| Study ends | February 11, 2028 |
| Registry record updated | September 11, 2026 |
| Trial ID | NCT07815886 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18+) with EGPA who are treated with benralizumab 30 mg every 4 weeks and have at least 3 months of follow-up data.
✕Probably not a fit
Patients who lack sufficient follow-up data or do not meet inclusion criteria may not contribute to observed benefits.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
BELONG-EGPA is a multicenter, retro-prospective observational study at European EGPA Study Group centers, assessing benralizumab 30 mg every 4 weeks in adults with EGPA. Researchers will collect clinical, laboratory, and lung function data from medical charts at baseline and at 3, 6, 12, and 24 months to evaluate effectiveness and safety in routine care. Primary outcomes include complete or partial disease response, changes in pre-bronchodilator FEV1, and relapse rates, with response definitions based on BVAS and steroid use. Inclusion requires confirmed EGPA by current criteria or MIRRA criteria, age 18+, and at least 3 months of follow-up after starting treatment. Data will be gathered via standardized electronic case report forms across participating centers.
Why it matters
Potential benefit: If successful, the study could clarify real-world benefits and safety of benralizumab for EGPA, guiding treatment decisions in clinical practice.
How similar studies have gone: Real-world data on benralizumab for EGPA are limited but prior registry and observational studies in similar vasculitides have shown potential benefits with good safety signals.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18 years or older. * Diagnosis of eosinophilic granulomatosis with polyangiitis (EGPA) according to the 2022 American College of Rheumatology/European Alliance of Associations for Rheumatology classification criteria or the criteria proposed in the MIRRA trial. * Treatment with benralizumab 30 mg every 4 weeks. * At least 3 months of available follow-up data after starting benralizumab. * Written informed consent for study participation and data collection. Exclusion Criteria: * Age younger than 18 years. * No available follow-up data after starting benralizumab. * Follow-up after benralizumab initiation shorter than 3 months. * Lack of written informed consent, where required by local regulations.
Where it's running
-
Edoardo Biancalana
Florence, Italy, Italy Recruiting
Study contacts
- Principal investigator: Giacomo Emmi, MD/PhD — University of Trieste, Italy
- Study coordinator: Giacomo Emmi, MD/PhD
- Email: giacomo.emmi0105@gmail.com
- Phone: +393286852815
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.