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Predictive Signature of Benralizumab Response

NCT04565483 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2024-04-26

No results posted yet for this study

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)

Conditions

Interventions

DRUG

Benralizumab Prefilled Syringe

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.

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • Ministère de la Santé - France

    collaborator UNKNOWN

  • Nantes University Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-11
Primary Completion
2026-10-31
Completion
2026-11-30

Countries

  • France

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04565483 on ClinicalTrials.gov