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NOT YET RECRUITING
NCT07013123
PHASE3

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

View on ClinicalTrials.gov

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

Interventions

DRUG

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

DRUG

Acarizax

Once asthma symptoms are controlled (D0), patients will take 18 months of Acarizax.

DRUG

Placebo

Once asthma symptoms are controlled (D0), patients will take 18 months of Placebo.