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

Launched by UNIVERSITY HOSPITAL, MONTPELLIER · Jun 5, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how well a new treatment called Acarizax works alongside an existing medication, Tezepelumab, for adults with severe asthma who are allergic to house dust mites. The goal is to see if this combination can help control asthma symptoms better than a placebo (a treatment that doesn't contain active medication). The trial will include adults aged 18 to 65 who have a history of severe asthma and are not well-controlled on their current treatments.

Participants will first receive Tezepelumab for 3 to 6 months to help control their asthma symptoms. If their asthma improves, they will be randomly assigned to one of two groups: one group will receive Tezepelumab plus Acarizax, while the other will get Tezepelumab plus a placebo. After six months, Tezepelumab will be stopped, and participants will continue with either Acarizax or placebo for an additional 12 months. Throughout the study, participants will have several check-ups and phone follow-ups to monitor their progress. To be eligible, participants must meet specific criteria, such as having a documented allergy to house dust mites and experiencing asthma attacks in the past year.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients aged ≥ 18 years and ≤ 65 years.
• • Patient followed by a specialist in allergy and/or respiratory diseases working at one of the investigating sites in France.
• • Patient allergic to HDM and with a clinical history of HDM-allergic asthma.
• • Positive specific IgE (≥ 0.35 kUA/L, ImmunoCAP®) and positive skin prick test for Dermtophagoides pteronyssinus and/or Dermtophagoides farinae at screening.
• • Patients satisfying diagnostic criteria for severe asthma, according to GINA international guidelines.
• • A clinical history of asthma exacerbations in the past two years.
• • A history of at least 2 asthma exacerbations during the previous 12 months.
• • Uncontrolled asthma (ACT \<20/25)
• • Lung function measured by FEV1 ≥ 70% of predicted value or according to local requirements.
• • Patients with persistent severe asthma who meet the Marketing Authorization criteria for Tezspire® (Tezepelumab) and Acarizax® prescriptions.
• Exclusion Criteria:
• • Patients sensitized and regularly exposed to animal dander, molds, and/or cockroach or any another perennial allergen.
• • Patients treated with a monoclonal antibody for asthma within the previous 3 months or 5 half-lives.
• • Patients who have received Sublingual immunotherapy (SLIT) or Sub-Cutaneous Immunotherapy (SCIT) treatment with DermatophagoIdes pteronyssinus and/or Dermatophagoïdes farinae within the previous 5 years.
• • Patients received any education provided by a medical indoor environment counselor during the 12 months before the study, or and educational program is programmed during the study.
• • Patients with acute respiratory tract infections.
• • The patient who have performed any specific measure for mites' avoidance during the 12 months before the study or plan to implement such measures during the study.
• • Pregnant, breastfeeding or lactating women.
• • Patients with a history of tumor, autoimmune, or immune deficiency pathology.
• • Patients with hematological pathology (coagulation disorders, anemia) that could interfere with the blood test.
• • The patient reports any previous hypersensitivity reaction to the active substance or excipients present in Tezspire® or Acarizax®.
• • Patients unable to read and/or write French language.
• • Absence of signed consent.
• • Patients who are not beneficiaries of the French social security system.
• • Presence of any condition (physical, psychological or other) that might, in the investigator's opinion, hinder study performance.
• • The patient is unavailable or unwilling to participate in future visits or is unable to comply with trial protocol.
• • Women of childbearing potential and fertile men not using effective contraception.
• • The patient is participating in another study for asthma and/or allergy treatment.
• • Patients in an exclusion period determined by a previous study or is currently participating to any other allergy/asthma trial.
• • Patients under legal protection (guardianship or curatorship)
• • Patients with a business or personal relationship with trial staff or sponsor who is directly involved with the conduct of the trial.