Predicting response to Benralizumab in severe asthma patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to identify a blood gene expression signature that can predict how well patients with severe eosinophilic asthma will respond to Benralizumab, a therapeutic monoclonal antibody. It is a multicenter, non-randomized trial conducted in France, where patients will be monitored over a 16-month period, including 12 months of treatment and a follow-up. The study will assess the reduction in asthma exacerbations associated with the treatment. Participants will undergo six clinical visits and phone calls to track their progress.

Why it matters

Who can join: the full rules

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

Where it's running

• 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

Study contacts

• Study coordinator: François-Xavier BLANC, MD-PHD
• Email: xavier.blanc@chu-nantes.fr
• Phone: +33240165545

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.