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Recruiting Phase 4

Predictive Signature of Benralizumab Response

NCT04565483 · tracked via the Priya Life Science France tracker
Phase
Phase 4
Started
2021-10-11
Last updated
2024-04-26

Condition(s) studied

Asthma; EosinophilicSevere Asthma

Investigational drug(s) / intervention(s)

Benralizumab Prefilled Syringe →

Benralizumab Prefilled Syringe: 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 summary

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)

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Predictive value of early blood gene expression signature of Benralizumab — 12 months
    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. We will evaluate an early blood gene expression signature of Benralizumab response through a clinically relevant reduction of the number of exacerbations at month 12 (M12).

Trial sites (20)

FacilityCityRegionStatus
Centre hospitalier Intercommunal Aix-en-Provence Aix-en-Provence France Recruiting
CHU Angers Angers France Recruiting
CHU Bordeaux Bordeaux France Recruiting
CHRU Brest Brest France Recruiting
CHU Dijon Dijon France Recruiting
CHU Grenoble Grenoble France Recruiting
Hôpital Bicêtre - AP-HP Le Kremlin-Bicêtre France Recruiting
CH Mans Le Mans France Withdrawn
CHU Lille Lille France Withdrawn
Hospices Civils de Lyon Lyon France Recruiting
Assistance Publique des Hôpitaux de Marseille Marseille France Not Yet Recruiting
CHU Montpellier Montpellier France Withdrawn
CHU Nantes Nantes France Recruiting
CHR Orléans Orléans France Recruiting
Hôpital Bichat - AP-HP Paris France Recruiting
CHU Rouen Rouen France Withdrawn
CHU Strasbourg Strasbourg France Recruiting
Hôpital FOCH Suresnes France Recruiting
CHU Toulouse Toulouse France Recruiting
Médipôle Hôpital Mutualiste de Villeurbanne Villeurbanne France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04565483 on ClinicalTrials.gov ↗ ← All trials in France