Informations générales (source: ClinicalTrials.gov)
Predictive Signature of Benralizumab Response (BENRAPRED)
Interventional
Phase 4
Nantes University Hospital (Voir sur ClinicalTrials)
octobre 2021
novembre 2026
29 juin 2024
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)
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| HOPITAL FOCH | COLAS TCHERAKIAN | 05/05/2025 07:12:08 | Contacter | ||
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| AP-HP - Hôpital Bichat | Camille TAILLE, MD-PHD | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Assistance Publique des Hôpitaux de Marseille - Marseille - France | Pascal CHANEZ, MD-PHD | Contact (sur clinicalTrials) | |||
| Centre hospitalier Intercommunal Aix-en-Provence - Aix-en-Provence - France | Youssef TRIGUI, MD-PHD | Contact (sur clinicalTrials) | |||
| CH Mans - Le Mans - France | Contact (sur clinicalTrials) | ||||
| CHR Orléans - Orléans - France | Sylvie DRUELLE | Contact (sur clinicalTrials) | |||
| CHRU Brest - Brest - France | Raphael LE MAO, MD-PHD | Contact (sur clinicalTrials) | |||
| CHU Angers - Angers - France | Hakima OUKSEL, MD | Contact (sur clinicalTrials) | |||
| CHU Dijon - Dijon - France | Philippe BONNIAUD, MD-PHD | Contact (sur clinicalTrials) | |||
| CHU Grenoble - Grenoble - France | Christel SAINT-RAYMOND, MD-PHD | Contact (sur clinicalTrials) | |||
| CHU Lille - Lille - France | Contact (sur clinicalTrials) | ||||
| CHU Montpellier - Montpellier - France | Contact (sur clinicalTrials) | ||||
| CHU Nantes - Nantes - France | François-Xavier BLANC, MD-PHD | Contact (sur clinicalTrials) | |||
| CHU Rouen - Rouen - France | Contact (sur clinicalTrials) | ||||
| CHU Strasbourg - Strasbourg - France | Naji KHAYATH, MD | Contact (sur clinicalTrials) | |||
| CHU Toulouse - Toulouse - France | Laurent GUILLEMINAULT, PD-PHD | Contact (sur clinicalTrials) | |||
| Hôpital Bicêtre - AP-HP - Le Kremlin-Bicêtre - France | Marc HUMBERT, MD-PHD | Contact (sur clinicalTrials) | |||
| Hôpital FOCH - Suresnes - France | Colas TCHERAKIAN, MD-PHD | Contact (sur clinicalTrials) | |||
| Hospices Civils de Lyon - Lyon - France | Gilles DEVOUASSOUX, MD-PHD | Contact (sur clinicalTrials) | |||
| Médipôle Hôpital Mutualiste de Villeurbanne - Villeurbanne - France | Jean-Marc DOT, MD-PHD | Contact (sur clinicalTrials) | |||
Critères
Tous
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
- 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
- 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