Benralizumab Effectiveness in EGPA (BELONG-EGPA)

September 8, 2026 updated by: European EGPA Study Group

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Italy
    • Italy
      • Florence, Italy, Italy, 50134

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Patients with EGPA treated with benralizumab
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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline and up to 24 months (at 3, 6, 12, 24 months)
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
Baseline, 3, 6, 12, and 24 months
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.
3, 6, 12, and 24 months
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.
Baseline and up to 24 months (at 3, 6, 12, 24 months)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
3, 6, 12, and 24 months
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
Baseline, 3, 6, 12, and 24 months
Oral corticosteroid discontinuation
Time Frame: 3, 6, 12, and 24 months
Proportion of patients who discontinue oral corticosteroid therapy during follow-up.
3, 6, 12, and 24 months
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
Baseline, 3, 6, 12, and 24 months
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.
3 months after dosage switch
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.
3, 6, 12, and 24 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Baseline, 3, 6, 12, and 24 months
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, 6, 12, and 24 months
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.
Baseline, 3, 6, 12, and 24 months
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.
Baseline, 3, 6, 12, and 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
European EGPA Study Group

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Giacomo Emmi, MD/PhD, University of Trieste, Italy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 11, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 11, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 11, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 27, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 8, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 11, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 11, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 8, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BENRA_22336_oss
  • 22336_oss (Registry Identifier: Ethics Committee of the Tuscany Region - Central Area (CEAVC))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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