Recruiting

BENRAPREDPredictive Signature of Benralizumab Response

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What is being tested

Benralizumab Prefilled Syringe

Drug
Who is being recruted

Asthma+12

+ Bronchial Diseases

+ Eosinophilia

From 18 to 75 Years
See all eligibility criteria
How is the trial designed

Other Study

Phase 4
Interventional
Study Start: October 2021
See protocol details

Summary

Principal SponsorNantes University Hospital
Study ContactFrançois-Xavier BLANC, MD-PHD
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: October 11, 2021

Actual date on which the first participant was enrolled.

The objective of the study is to establish the predictive value of early blood gene expression signature of Benralizumab response associated with a significant reduction of the number of exacerbations in treated severe asthmatic patients. This trial is a French, multicenter and no-randomized trial. Patients enrolled will be clinically followed for 16 months (the treatment period: 12 months and 1 month follow-up; 6 clinical visit on site and in phone call at 13 months)

Official TitlePredictive Signature of Benralizumab Response
NCT04565483
Principal SponsorNantes University Hospital
Study ContactFrançois-Xavier BLANC, MD-PHD
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

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

220 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Other Study

Some studies explore topics that don't fall into a specific category. These might include innovative research, new technologies, or emerging healthcare areas.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

AsthmaBronchial DiseasesEosinophiliaHematologic DiseasesHemic and Lymphatic DiseasesHypersensitivityHypersensitivity, ImmediateImmune System DiseasesLeukocyte DisordersLung DiseasesLung Diseases, ObstructivePulmonary EosinophiliaRespiratory HypersensitivityRespiratory Tract DiseasesHypereosinophilic Syndrome

Criteria

Inclusion Criteria: * Patients between 18 and 75 years old. * Patients diagnosed with severe asthma (Chung and al, Eur Respir J 2014), i.e.: * asthma requiring high doses of ICS (\>1000 microgram per day of Beclomethasone or equivalent) associated with LABA and/or systemic corticosteroids to be controlled over one year, * and/or uncontrolled asthma despite the later medications, * and/or a controlled asthma worsening after decreasing medications, * Documented historical reversibility of FEV1 ≥12% and FEV1 gain ≥ 200 milliliter * ACQ-7 score ≥ 1,5 at M0. * ≥ 3 exacerbations in the 12 months prior to screening visit M-1. * Eosinophil blood count ≥ 0,3 G/L at inclusion visit or in the 12 months prior to the inclusion visit. If eosinophil blood count is ≥ 0,15 G/L and \< 0,3 G/L, an eosinophilic phenotype defined by at least 1 of the following criteria will be required: * Fractional Exhaled Nitric Oxide (FeNO) \> 25 ppm at inclusion visit or in the 12 months prior to the inclusion visit. * Sputum eosinophils ≥ 3% at inclusion visit or in the 12 months prior to the inclusion visit. * Patients who provide written informed consent prior to participation in the study Exclusion Criteria: * Patients diagnosed with difficult-to-treat asthma and/or with uncontrolled asthma differential diagnosis according to the judgment of the investigator (e.g., vocal cord dysfunction, gastroesophageal reflux disease, granulomatous eosinophilic vasculitis, obstructive sleep apnea syndrome, hyperventilation syndrome, allergic broncho-pulmonary aspergillosis, Carrington disease, DIPNECH, asthma/COPD overlap syndrome). * Non-adherent patients to inhaled treatment (ICS + LABA). * Active smokers or former smokers exceeding 20 packs year. * Exacerbation at inclusion visit M0. * Active malignancy or malignancy in remission over less than 5 years. * Active parasitic infection or parasitic infection in the past 24 weeks. * Hypersensitivity to Benralizumab or to any of the excipients of Fasenra® (histidine, histidine hydrochloride monohydrate, trehalose dihydrate, polysorbate 20) * Patients requiring other immunosuppressive and immunomodulator drugs * Patients requiring other biotherapy than Benralizumab, with or without French's marketing authorisation in severe asthma * Patients requiring other biotherapy than Benralizumab that affects the immune system * SARS-COV2 infection * Pregnancy, lactation, or patients with childbearing potential refusing efficient contraceptive method. * Patients under psychiatric condition altering their comprehension and their ability to give informed consent. * Patients already enrolled in a clinical interventional research. * Patients not affiliated to a health insurance plan * Patients under guardianship, curators or safeguard of justice

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Patients receive BENRALIZUMAB if they meet the criteria for inclusion and non-inclusion at the inclusion visit. Injections take place at the inclusion visit, at 1 month, 2 months, 4 months, 6 months, 8 months, 10 months and 12 months.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 20 locations

Recruiting

Centre hospitalier Intercommunal Aix-en-Provence

Aix-en-Provence, FranceOpen Centre hospitalier Intercommunal Aix-en-Provence in Google Maps
Recruiting

CHU Angers

Angers, France
Recruiting

CHU Bordeaux

Bordeaux, France
Recruiting

CHRU Brest

Brest, France
Recruiting
20 Study Centers