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NCT Number: NCT07815886

Benralizumab Effectiveness in EGPA

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.

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Key information

Conditions

Eosinophilic Granulomatosis With Polyangiitis (EGPA) Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis Autoimmune Diseases Cardiovascular Diseases Churg-Strauss Syndrome Granuloma Hemic and Lymphatic Diseases Immune System Diseases Lymphatic Diseases Lymphoproliferative Disorders Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Systemic Vasculitis Vascular Diseases Vasculitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Benralizumab 30 mg/ml

Biological

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.

Primary outcomes

  1. Complete Response

    Time frame: Baseline and up to 24 months (at 3, 6, 12, 24 months)

    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.

  2. Change in Lung Function

    Time frame: Baseline, 3, 6, 12, and 24 months

    Change in pre-bronchodilator forced expiratory volume in 1 second (FEV1) from baseline to each follow-up time point.

    Unit of Measure: Milliliters

  3. Disease relapse

    Time frame: 3, 6, 12, and 24 months

    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.

  4. Partial response

    Time frame: Baseline and up to 24 months (at 3, 6, 12, 24 months)

    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.

Secondary outcomes

  1. Treatment persistence

    Time frame: 3, 6, 12, and 24 months

    Proportion of patients who continue benralizumab treatment, switch benralizumab dosage, or discontinue benralizumab for any reason.

  2. Change in oral corticosteroid dose expressed as prednisone-equivalent dose

    Time frame: Baseline, 3, 6, 12, and 24 months

    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

  3. Oral corticosteroid discontinuation

    Time frame: 3, 6, 12, and 24 months

    Proportion of patients who discontinue oral corticosteroid therapy during follow-up.

  4. Overall clinical benefit in first-line versus post-mepolizumab patients

    Time frame: Baseline, 3, 6, 12, and 24 months

    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

  5. Effectiveness after benralizumab dosage switching

    Time frame: 3 months after dosage switch

    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.

  6. Adverse event rate

    Time frame: 3, 6, 12, and 24 months

    Proportion of patients experiencing at least one adverse event during benralizumab treatment, regardless of causal association with treatment.

Other outcomes

  1. Changes in organ manifestations

    Time frame: Baseline, 3, 6, 12, and 24 months

    Change in the proportion of patients with active EGPA-related organ manifestations assessed separately from Birmingham Vasculitis Activity Score items.

  2. DMARD discontinuation rate

    Time frame: 3, 6, 12, and 24 months

    Proportion of patients discontinuing disease-modifying antirheumatic drug treatment that was ongoing or newly started at baseline.

  3. Change in ANCA positivity

    Time frame: Baseline, 3, 6, 12, and 24 months

    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.

  4. Change in eosinophil count

    Time frame: Baseline, 3, 6, 12, and 24 months

    Change in blood eosinophil count from baseline to each follow-up time point.

Study contacts

Contact information is provided by the study sponsor or research team.

Giacomo Emmi, MD/PhD

CONTACT

[email protected]

+393286852815

Irene Mattioli, PharmD/PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

European EGPA Study Group

Network

Registry information

Official study title

Benralizumab Effectiveness in the LONG-term Real-life Setting in EGPA: The BELONG-EGPA Study

Acronym: BELONG-EGPA

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Sep 11, 2026
Registry last updated
Sep 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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