Actively Recruiting
Predictive Signature of Benralizumab Response
Led by Nantes University Hospital · Updated on 2024-04-26
220
Participants Needed
20
Research Sites
263 weeks
Total Duration
On this page
Sponsors
N
Nantes University Hospital
Lead Sponsor
A
AstraZeneca
Collaborating Sponsor
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official Title
Predictive Signature of Benralizumab Response
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients between 18 and 75 years old
- Diagnosed with severe asthma requiring high doses of inhaled corticosteroids (>1000 microgram per day of Beclomethasone or equivalent) with LABA and/or systemic corticosteroids to be controlled over one year
- Uncontrolled asthma despite these medications, or worsening asthma after decreasing medications
- Documented reversibility of FEV1 ≥12% and FEV1 gain ≥200 milliliter
- ACQ-7 score ≥1.5 at inclusion visit
- At least 3 exacerbations in the 12 months prior to screening
- Eosinophil blood count ≥0.3 G/L at inclusion or prior 12 months, or if between 0.15 and 0.3 G/L, eosinophilic phenotype confirmed by FeNO >25 ppm or sputum eosinophils ≥3%
- Provided written informed consent prior to participation
You will not qualify if you...
- Diagnosed with difficult-to-treat asthma or uncontrolled asthma differential diagnosis (e.g., vocal cord dysfunction, GERD, vasculitis, sleep apnea, hyperventilation, allergic broncho-pulmonary aspergillosis, Carrington disease, DIPNECH, asthma/COPD overlap)
- Non-adherent to inhaled treatment (ICS + LABA)
- Active smokers or former smokers >20 pack years
- Exacerbation at inclusion visit
- Active malignancy or malignancy in remission less than 5 years
- Active or recent (past 24 weeks) parasitic infection
- Hypersensitivity to Benralizumab or its excipients
- Use of other immunosuppressive or immunomodulatory drugs
- Use of other biotherapies than Benralizumab affecting the immune system
- SARS-COV2 infection
- Pregnancy, lactation, or refusal of effective contraception if of childbearing potential
- Psychiatric conditions impairing consent
- Already enrolled in another interventional clinical research
- Not affiliated to a health insurance plan
- Under guardianship, curatorship, or legal protection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 20 locations
1
Centre hospitalier Intercommunal Aix-en-Provence
Aix-en-Provence, France
Actively Recruiting
2
CHU Angers
Angers, France
Actively Recruiting
3
CHU Bordeaux
Bordeaux, France
Actively Recruiting
4
CHRU Brest
Brest, France
Actively Recruiting
5
CHU Dijon
Dijon, France
Actively Recruiting
6
CHU Grenoble
Grenoble, France
Actively Recruiting
7
Hôpital Bicêtre - AP-HP
Le Kremlin-Bicêtre, France
Actively Recruiting
8
CH Mans
Le Mans, France
Withdrawn
9
CHU Lille
Lille, France
Withdrawn
10
Hospices Civils de Lyon
Lyon, France
Actively Recruiting
11
Assistance Publique des Hôpitaux de Marseille
Marseille, France
Not Yet Recruiting
12
CHU Montpellier
Montpellier, France
Withdrawn
13
CHU Nantes
Nantes, France
Actively Recruiting
14
CHR Orléans
Orléans, France
Actively Recruiting
15
Hôpital Bichat - AP-HP
Paris, France
Actively Recruiting
16
CHU Rouen
Rouen, France
Withdrawn
17
CHU Strasbourg
Strasbourg, France
Actively Recruiting
18
Hôpital FOCH
Suresnes, France
Actively Recruiting
19
CHU Toulouse
Toulouse, France
Actively Recruiting
20
Médipôle Hôpital Mutualiste de Villeurbanne
Villeurbanne, France
Actively Recruiting
Research Team
F
François-Xavier BLANC, MD-PHD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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