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Predicting response to Benralizumab in severe asthma patients

Predictive Signature of Benralizumab Response

Phase 4 Interventional Nantes University Hospital · NCT04565483

This study is testing if a specific blood test can help predict how well people with severe asthma will respond to the medication Benralizumab.

Quick facts

PhasePhase 4
Study typeInterventional
Enrollment220 (estimated)
Ages18 Years to 75 Years
SexAll
SponsorNantes University Hospital Academic / other
Drugs / interventionsBenralizumab
Locations20 sites (Aix-en-Provence and 19 other locations)
Trial IDNCT04565483 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with severe asthma requiring high doses of medication and a history of exacerbations.

Not a fit: Patients with mild asthma or those who do not meet the specific criteria for eosinophilic asthma may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to personalized treatment strategies for severe asthma patients, improving their management and quality of life.

How similar studies have performed: Other studies have shown promise in using biomarkers for predicting responses to asthma treatments, suggesting this approach may be viable.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Aix-en-Provence and 19 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions AsthmaEosinophilicSevere Asthmasevere asthmatherapeutic monoclonal antibodypersonalized medicinetranscriptomicbiomarkers
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.