mepolizumab for Severe allergic and eosinophilic asthma

Inclusion criteria

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

Exclusion criteria

• {"criterion_text":"- 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"}
• {"criterion_text":"- Difficult to treat asthma and others severe respiratory diseases"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- Pregnant, post-partum or lactating women"}
• {"criterion_text":"- Known sensitivity to any of the active substances or their excipients to be administered during the study"}
• {"criterion_text":"- Active malignancy or malignancy in remission over less than 5 years"}
• {"criterion_text":"- Patient not affiliated to a health insurance plan (FR)"}

Primary endpoints

• {"endpoint_text":"- 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).","definition_or_measurement_approach":"Rate of severe exacerbation measured during one year; comparison of annual rate between omalizumab and mepolizumab. Additional primary measure: rate of response to omalizumab versus mepolizumab in overall and stratified populations (rates compared across groups)."}

Secondary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Clinical features and biomarkers analyzed in blood, mucosal and urine samples; candidate predictors include age at severe disease onset, presence of nasal polyps or aspirin hypersensitivity, serum specific/total IgE ratio, and blood eosinophil levels; tested for predictive ability of response to each biologic."}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Disease control measured by ACT and ACQ6; quality of life by AQLQ; lung function by FEV1 % predicted and absolute change; nasal symptoms by VAS and endoscopic scoring for nasal polyps; assessed in treatment groups overall and by strata."}

Belgium

Earliest CTIS Part Ii Submission Date

19-11-2024

Latest Decision Or Authorization Date

28-11-2024

Processing Time Days

9

Number Of Sites

8

Number Of Participants

100

France

Earliest CTIS Part Ii Submission Date

19-11-2024

Latest Decision Or Authorization Date

06-12-2024

Processing Time Days

17

Number Of Sites

14

Number Of Participants

240

Primary sponsor

Full Name

Cliniques Universitaires Saint-Luc

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Belgium

Third parties

• {"country":"","full_name":"Novartis Europharm Limited","duties_or_roles":"Monetary support","organisation_type":""}
• {"country":"","full_name":"GlaxoSmithKline Trading Services Limited","duties_or_roles":"Monetary support","organisation_type":""}