Predictive factors of response to omalizumab and mepolizumab in asthma.

Phase 1

• Conditions: Adult patients (18-90 years old) with severe asthma and eligible for both XOLAIR and NUCALA therapies, and agreeing on participating (signature of a written informed consent).; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2017-002473-19-FR
• Lead Sponsor: Cliniques Universitaires Saint-Luc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-06-24
• Last Update Posted: 15 September 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 364

Inclusion Criteria

oSigned informed consent form (ICF),
oAge >18+ years (18-90 years old) at time of signing ICF,
oAble to comply with the study protocol, in the investigator’s judgment,
oDocumented physician-diagnosed asthma ,
oand eligible to omalizumab and mepolizumab and who have not yet received any of these therapies. Eligibility criteria to omalizumab or mepolizumab are defined by all of these characteristics :
?patients with severe asthma remaining uncontrolled despite optimal, high-dose inhaled ICS therapy and LABA; (alternative add-on medication could consist of LTRA or low-dose theophylline),
?? 2 severe exacerbations in the previous year (as defined by requiring oral or injective corticosteroids for ?3 days or a doubled dose for cortico-dependent patients, or by emergency room visit or hospitalisation for asthma),
?impaired lung function (FEV1 < 80% predicted),
?increased serum total IgE between 76 and 700 kU/L (but a range of 30 to 1.300 kU/L also applicable in countries other than Belgium, such as France according to EMA and national rules),
?allergic background evidenced by specific IgE ? 0.35 kU/L and/or skin prick-test reactivity to at least one perennial allergen,
?and blood eosinophils ? 300/?L in at least two samples, just before initiation and during the previous year.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 145
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 219

Exclusion Criteria

oHistory 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,
oDifficult to treat asthma and others severe respiratory diseases,
oPatient 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,
oProtected 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;
oPregnant, post-partum or lactating women;
oKnown sensitivity to any of the active substances or their excipients to be administered during the study;
oActive malignancy or malignancy in remission over less than 5 years.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified