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Potency of HDM Sublingual AIT Tablets in Assuring the Persistency of Asthma Control in HDM Allergic Patients With Severe Asthma, Treated With Tezepelumab
Sponsor: University Hospital, Montpellier
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).
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
38
Start Date
2025-07-15
Completion Date
2029-08-18
Last Updated
2025-06-10
Healthy Volunteers
No
Conditions
Interventions
Tezepelumab
Patients will take Tezepelumab for 3 to 6 months (M-3/-6) to control asthma symptoms. Once asthma symptoms are controlled (D0), patients will take an additionnal of 18 months of Tezepelumab
Acarizax
Once asthma symptoms are controlled (D0), patients will take 18 months of Acarizax.
Placebo
Once asthma symptoms are controlled (D0), patients will take 18 months of Placebo.