Predictive factors and magnitude of response to omalizumab and mepolizumab in allergic and eosinophilic severe asthma: PREDICTUMAB, an open-label, controlled, randomized multinational pragmatic trial.

Cliniques Universitaires Saint-Luc21 sites in 2 countries340 target enrollmentNovember 28, 2024

DrugsSB240563 OMALIZUMAB IGE-025A MEPOLIZUMAB SYN008

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Not specified
Sponsor: Cliniques Universitaires Saint-Luc
Enrollment: 340
Locations: 21
Primary Endpoint: The primary criterion for judgment will be the rate of severe exacerbation during one year in patients on omalizumab vs mepolizumab, in the overall population. An additional primary criterion will be the rate of response to omalizumab vs that for mepolizumab, in the overall and stratified population(s).
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

To compare the rate and magnitude of response to omalizumab and mepolizumab in patients with severe allergic and eosinophilic asthma, in terms of annual rate of severe exacerbations (primary outcome).

Registry

euclinicaltrials.eu

Start Date

November 28, 2024

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Investigators

Sponsor

Cliniques Universitaires Saint-Luc

Responsible Party

Principal Investigator

Charles Pilette

Scientific

Cliniques Universitaires Saint-Luc

Eligibility Criteria

Inclusion Criteria

•Signed informed consent form (ICF)
•Age >18+ years (18-90 years old) at time of signing ICF
•Able to comply with the study protocol, in the investigator’s judgment
•Documented physician-diagnosed asthma
•Eligible to omalizumab and mepolizumab and who have not yet received any of these therapies

Exclusion Criteria

•History of evidence of drug/substance abuse that would pose a risk to patient safety, interfere with the conduct of study, have an impact on the study results, or affect the patient’s ability to participate in the study, in the opinion of the investigator
•Difficult to treat asthma and others severe respiratory diseases
•Patient already currently/actively enrolled in a clinical therapeutic trial (testing another drug); the concomitant inclusion in a Registry, which may include biosampling, is not an exclusion criterion
•Protected subjects (sous tutelle or curatelle), patients who are unable to express their consent, subjects who are deprived of liberty, subjects who are hospitalized without consent, subjects who are admitted in a health-care or social institute with another aim than that of the research, inclusion in an emergency situation, patient who is subject to a court order
•Pregnant, post-partum or lactating women
•Known sensitivity to any of the active substances or their excipients to be administered during the study
•Active malignancy or malignancy in remission over less than 5 years
•Patient not affiliated to a health insurance plan (FR)

Outcomes

Primary Outcomes

The primary criterion for judgment will be the rate of severe exacerbation during one year in patients on omalizumab vs mepolizumab, in the overall population. An additional primary criterion will be the rate of response to omalizumab vs that for mepolizumab, in the overall and stratified population(s).

Secondary Outcomes

Clinical features and biomarkers (or array signatures) analyzed in blood, mucosal and urine samples will be tested for their putative ability to predict a better response to oma- or mepolizumab (theranostic value). The candidate features are age at (severe) disease onset and presence of nasal polyps or aspirin hypersensitivity as well as serum specific/total IgE ratio and blood eosinophil levels.
Asthma-related outcomes other than exacerbations – i.e. disease control reflected by ACT and ACQ6, asthma-related quality of life questionnaire reflected by AQLQ, lung function reflected by FEV1 % predicted and absolute change - as well as nasal symptoms (VAS and, for nasal polyps, endoscopic scoring) will be assessed in the oma- and mepolizumab groups, in the overall and stratified populations.