Overview

Potency of HDM Sublingual AIT Tablets in Assuring the Persistency of Asthma Control in HDM Allergic Patients With Severe Asthma, Treated With Tezepelumab

Status:
NOT_YET_RECRUITING

Trial end date:
2029-08-18

Target enrollment:

Participant gender:

Summary

The aim of this drug trial is to evaluate the annualized asthma exacerbation rate under treatment with Acarizax versus placebo. The trial is intended for adults aged 18 to 65 with severe uncontrolled asthma and a house dust mite allergy. The study will involve 32 patients (up to 38 with study dropouts) recruited from French hospitals, in pulmonology and allergology departments. Initially, all participants will receive Tezepelumab for 3 to 6 months (M-3/-6) to control asthma symptoms. If asthma is not controlled after 6 months, the participant will be excluded from the study and will continue on standard treatment. Once their asthma is controlled, patients will be randomized in two groups: * Group A: Tezepelumab + Acarizax * Group B: Tezepelumab + Placebo After 6 months of treatment with Acarizax or placebo (M6), Tezepelumab will be stopped and participants will continue treatment with Acarizax or placebo alone for a further 12 months (up to M18/End of search). The study will include 5 visits during regular consultations (M-3/M-6, D0, M6, M12 and M18), as well as 2 follow-up telephone calls M3 and M9).

Phase:

PHASE3

Details

Lead Sponsor:

University Hospital, Montpellier

Collaborators:

ALK-Abell A/S
AstraZeneca
ThermoFisher Scientific Brahms Biomarkers France
University hospital of Nmes

Treatments:

tezepelumab