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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

NCT07013123 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2025-06-10

No results posted yet for this study

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).

Conditions

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.

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • ALK-Abelló A/S

    collaborator INDUSTRY

  • University hospital of Nîmes

    collaborator UNKNOWN

  • ThermoFisher Scientific Brahms Biomarkers France

    collaborator INDUSTRY

  • University Hospital, Montpellier

    lead OTHER

Principal Investigators

  • Davide CAIMMI, MD, PhD · University Hospital, Montpellier

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-15
Primary Completion
2029-08-18
Completion
2029-08-18

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07013123 on ClinicalTrials.gov