An observational study in Eosinophilic Granulomatosis With Polyangiitis (EGPA), sponsored by European EGPA Study Group. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-11.
Sponsored by European EGPA Study Group · Observational
This is a multicenter, retro-prospective observational study evaluating the effectiveness and safety of benralizumab in adult patients with eosinophilic granulomatosis with polyangiitis (EGPA) in a real-world setting. The study will include patients treated with benralizumab 30 mg every 4 weeks at EGPA referral centers participating in the European EGPA Study Group. Clinical, laboratory, lung function, treatment, relapse, and safety data will be collected from medical charts at baseline and during follow-up up to 24 months.
BELONG-EGPA is a multicenter, retro-prospective observational study conducted within centers belonging to the European EGPA Study Group. The study is designed to evaluate the long-term real-world effectiveness and safety of benralizumab in adult patients with eosinophilic granulomatosis with polyangiitis (EGPA).
The study population will include adult patients with EGPA who meet the 2022 American College of Rheumatology/European Alliance of Associations for Rheumatology classification criteria for EGPA or the criteria proposed in the MIRRA trial, and who receive benralizumab 30 mg every 4 weeks. Only patients with at least 3 months of available follow-up after starting benralizumab will be included.
Demographic, clinical, biological, lung function, and treatment-related data will be collected from medical charts through a standardized electronic case report form. Data will be collected at the start of benralizumab treatment and at 3, 6, 12, and 24 months of follow-up.
The primary effectiveness outcomes include achievement of complete response and partial response, changes in lung function measured by pre-bronchodilator FEV1, and disease relapses. Complete response is defined as no disease activity, with Birmingham Vasculitis Activity Score equal to 0, and an oral corticosteroid dose of 4.0 mg/day or less of prednisone, prednisolone, or equivalent. Partial response is defined as no disease activity with an oral corticosteroid dose greater than 4.0 mg/day.
Secondary outcomes include treatment persistence, oral corticosteroid tapering and discontinuation, effectiveness and safety in first-line patients compared with patients previously exposed to mepolizumab, outcomes after benralizumab dosage switching, and adverse events and serious adverse events during treatment.
Additional outcomes include changes in organ manifestations, discontinuation of disease-modifying antirheumatic drugs, changes in ANCA status, and variation in eosinophil count. All data will be anonymized and stored in a centralized database.
61 studies on the registry are indexed under Churg-Strauss Syndrome; 17 are open to participants now.
This study's planned enrollment of 100 is below the median of 239 across 30 observational studies indexed under Churg-Strauss Syndrome.
Browse Churg-Strauss Syndrome studies →European EGPA Study Group is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
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Adult patients with eosinophilic granulomatosis with polyangiitis (EGPA) treated with benralizumab 30 mg every 4 weeks at EGPA referral centers participating in the European EGPA Study Group. Patients may be newly diagnosed or have relapsing or refractory EGPA, and will be included if at least 3 months of follow-up data after benralizumab initiation are available.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adult patients with eosinophilic granulomatosis with polyangiitis (EGPA) receiving benralizumab 30 mg every 4 weeks in a real-world setting. Patients may be newly diagnosed or have relapsing or refractory EGPA and must have at least 3 months of available follow-up after starting benralizumab.
Biological: Benralizumab 30 mg/ml
Drug page: Benralizumab
Benralizumab administered at a dose of 30 mg every 4 weeks in adult patients with eosinophilic granulomatosis with polyangiitis (EGPA) in a real-world setting. Patients may receive benralizumab as first-line biologic therapy or after previous exposure to mepolizumab. Treatment use, persistence, dosage changes, effectiveness outcomes, and safety events will be assessed during follow-up.
Complete Response
Proportion of patients achieving complete response during follow-up. Complete response is defined as no disease activity (BVAS=0) and oral corticosteroid dose ≤4.0 mg/day.
Time frame: Baseline and up to 24 months (at 3, 6, 12, 24 months)
Change in Lung Function
Change in pre-bronchodilator forced expiratory volume in 1 second (FEV1) from baseline to each follow-up time point. Unit of Measure: Milliliters
Time frame: Baseline, 3, 6, 12, and 24 months
Disease relapse
Proportion of patients experiencing disease relapse after achieving complete response. Relapse is defined as active vasculitis, BVAS \>0, and/or worsening asthma or ear-nose-throat manifestations leading to an increase in oral corticosteroid dose to \>4.0 mg/day, initiation of a new immunosuppressive therapy, or hospitalization.
Time frame: 3, 6, 12, and 24 months
Partial response
Proportion of patients achieving complete response during follow-up. Partial response is defined as no disease activity (BVAS=0) and oral corticosteroid dose \>4.0 mg/day.
Time frame: Baseline and up to 24 months (at 3, 6, 12, 24 months)
Treatment persistence
Proportion of patients who continue benralizumab treatment, switch benralizumab dosage, or discontinue benralizumab for any reason.
Time frame: 3, 6, 12, and 24 months
Change in oral corticosteroid dose expressed as prednisone-equivalent dose
The daily dose of each oral corticosteroid will be converted to prednisone-equivalent mg/day using standardized glucocorticoid equivalence factors. Unit of Measure: mg/day of prednisone equivalent
Time frame: Baseline, 3, 6, 12, and 24 months
Oral corticosteroid discontinuation
Proportion of patients who discontinue oral corticosteroid therapy during follow-up.
Time frame: 3, 6, 12, and 24 months
Overall clinical benefit in first-line versus post-mepolizumab patients
A comparison of the overall clinical benefit in patients treated with benralizumab as first-line therapy versus patients switching to benralizumab following prior exposure to mepolizumab. Unit of Measure: Percentage of participants
Time frame: Baseline, 3, 6, 12, and 24 months
Effectiveness after benralizumab dosage switching
Assessment of complete response, partial response, and changes in lung function in patients switching benralizumab dosage from 30 mg every 4 weeks to 30 mg every 8 weeks or from 30 mg every 8 weeks to 30 mg every 4 weeks.
Time frame: 3 months after dosage switch
Adverse event rate
Proportion of patients experiencing at least one adverse event during benralizumab treatment, regardless of causal association with treatment.
Time frame: 3, 6, 12, and 24 months
Changes in organ manifestations
Change in the proportion of patients with active EGPA-related organ manifestations assessed separately from Birmingham Vasculitis Activity Score items.
Time frame: Baseline, 3, 6, 12, and 24 months
DMARD discontinuation rate
Proportion of patients discontinuing disease-modifying antirheumatic drug treatment that was ongoing or newly started at baseline.
Time frame: 3, 6, 12, and 24 months
Change in ANCA positivity
Change in the proportion of patients with positive ANCA testing and proportion of patients with ANCA negativization among those who were ANCA-positive at baseline.
Time frame: Baseline, 3, 6, 12, and 24 months
Change in eosinophil count
Change in blood eosinophil count from baseline to each follow-up time point.
Time frame: Baseline, 3, 6, 12, and 24 months
Plan to share: No
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European EGPA Study Group