NCT04565483

Brief 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)

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P75+ for phase_4

Timeline
6mo left

Started Oct 2021

Longer than P75 for phase_4

Geographic Reach
1 country

20 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress90%
Oct 2021Nov 2026

First Submitted

Initial submission to the registry

September 21, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 25, 2020

Completed
1 year until next milestone

Study Start

First participant enrolled

October 11, 2021

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Last Updated

April 26, 2024

Status Verified

April 1, 2024

Enrollment Period

5 years

First QC Date

September 21, 2020

Last Update Submit

April 25, 2024

Conditions

Asthma; EosinophilicSevere Asthma

Keywords

severe asthmatherapeutic monoclonal antibodypersonalized medicinetranscriptomicbiomarkers

Outcome Measures

Primary Outcomes (1)

  • Predictive value of early blood gene expression signature of Benralizumab

    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. We will evaluate an early blood gene expression signature of Benralizumab response through a clinically relevant reduction of the number of exacerbations at month 12 (M12).

    12 months

Secondary Outcomes (6)

  • Molecular signature predictive of stabilization

    12 months

  • The stability of the signature over time

    0 month, 3 months, 6 months and 9 months

  • The association of gene expression patterns

    12 months

  • Association of gene expression patterns and clinical characteristics

    0 months

  • Stratification value of gene expression in severe asthma

    12 months

  • +1 more secondary outcomes

Study Arms (1)

BENRALIZUMAB

EXPERIMENTAL

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.

Drug: Benralizumab Prefilled Syringe

Interventions

Benralizumab Prefilled SyringeDRUG

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.

Also known as: Transcriptomic
BENRALIZUMAB

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • Patients who provide written informed consent prior to participation in the study

You may not qualify if:

  • 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.
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

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

Hôpital Bicêtre - AP-HP

Le Kremlin-Bicêtre, France

RECRUITING

CH Mans

Le Mans, France

WITHDRAWN

CHU Lille

Lille, France

WITHDRAWN

Hospices Civils de Lyon

Lyon, France

RECRUITING

Assistance Publique des Hôpitaux de Marseille

Marseille, France

NOT YET RECRUITING

CHU Montpellier

Montpellier, France

WITHDRAWN

CHU Nantes

Nantes, France

RECRUITING

CHR Orléans

Orléans, France

RECRUITING

Hôpital Bichat - AP-HP

Paris, France

RECRUITING

CHU Rouen

Rouen, France

WITHDRAWN

CHU Strasbourg

Strasbourg, France

RECRUITING

Hôpital FOCH

Suresnes, France

RECRUITING

CHU Toulouse

Toulouse, France

RECRUITING

Médipôle Hôpital Mutualiste de Villeurbanne

Villeurbanne, France

RECRUITING

MeSH Terms

Conditions

Pulmonary EosinophiliaAsthma

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHypereosinophilic SyndromeEosinophiliaLeukocyte DisordersHematologic DiseasesHemic and Lymphatic DiseasesBronchial DiseasesLung Diseases, ObstructiveRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Central Study Contacts

François-Xavier BLANC, MD-PHD

CONTACT

+33240165545xavier.blanc@chu-nantes.fr

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2020

First Posted

September 25, 2020

Study Start

October 11, 2021

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

November 1, 2026

Last Updated

April 26, 2024

Record last verified: 2024-04

Locations

FR(20)