RecruitingPhase 4NCT04565483

Predictive Signature of Benralizumab Response


Sponsor

Nantes University Hospital

Enrollment

220 participants

Start Date

Oct 11, 2021

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study uses biological samples to identify markers in the blood that can predict which patients with severe asthma will respond well to benralizumab — a biologic injection that targets a white blood cell type (eosinophils) that drives asthma inflammation. **You may be eligible if...** - You are between 18 and 75 years old - You have severe asthma requiring high doses of inhaled steroids plus additional medications, and your asthma is still poorly controlled or worsens when medications are reduced - You have had at least 3 asthma flare-ups in the past year - Your blood shows signs of eosinophilic (allergy-related) inflammation - You have documented reversibility of airflow obstruction on breathing tests **You may NOT be eligible if...** - Your breathing problems are due to a different condition (such as vocal cord dysfunction or sleep apnea) - You have another condition causing eosinophilia - You are pregnant or breastfeeding - You have severe uncontrolled medical conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBenralizumab 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.


Locations(20)

Centre hospitalier Intercommunal Aix-en-Provence

Aix-en-Provence, France

CHU Angers

Angers, France

CHU Bordeaux

Bordeaux, France

CHRU Brest

Brest, France

CHU Dijon

Dijon, France

CHU Grenoble

Grenoble, France

Hôpital Bicêtre - AP-HP

Le Kremlin-Bicêtre, France

CH Mans

Le Mans, France

CHU Lille

Lille, France

Hospices Civils de Lyon

Lyon, France

Assistance Publique des Hôpitaux de Marseille

Marseille, France

CHU Montpellier

Montpellier, France

CHU Nantes

Nantes, France

CHR Orléans

Orléans, France

Hôpital Bichat - AP-HP

Paris, France

CHU Rouen

Rouen, France

CHU Strasbourg

Strasbourg, France

Hôpital FOCH

Suresnes, France

CHU Toulouse

Toulouse, France

Médipôle Hôpital Mutualiste de Villeurbanne

Villeurbanne, France

View Full Details on ClinicalTrials.gov

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NCT04565483


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