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

NCT07013123 | Not Yet Recruiting Phase 3 DMC

• 2 other identifiers: RECHMPL25_00692025-521258-41-00
• Study Type: interventional
• Target: 38
• Locations: 0 countries
• Sites: N/A

Brief 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

Severe Asthma; Allergy to House Dust Mites

Keywords

Asthma; Dust Mite Allergy; Allergen immunotherapy

Outcome Measures

Primary Outcomes (1)

• Annualized total number of asthma exacerbations under acarizax/placebo treatment

  The number of asthma exacerbations will be recorded by the participant in their follow-up diary throughout the Acarizax or placebo treatment period. Day 0 marks the start of Acarizax/placebo treatment, and Month 18 marks the end.

  Between Day 0 and Month 18

Secondary Outcomes (14)

• Annualized total number of asthma exacerbations without Tezepelumab

  Between Month 6 and Month 18 (during 21 to 24 months)

• ACT score

  At the start of Tezepelumab treatment (Month -3/-6), Day 0, Month 3, Month 6, Month 9, Month 12 and Month 18

• ARCT score only for patients suffering from allergic rhinitis

  At the start of Tezepelumab treatment (Month -3/-6), Day 0, Month 3, Month 6, Month 9, Month 12 and Month 18

• Forced Expiratory Volume (FEV1)

  At the start of Tezepelumab treatment (Month -3/-6), Day 0, Month 6, Month 12 and Month 18

• Forced vital capacity (FVC)

  At the start of Tezepelumab treatment (Month -3/-6), Day 0, Month 6, Month 12 and Month 18

Study Arms (2)

Tezepelumab + Acarizax

EXPERIMENTAL

Participants will receive Tezepelumab for 3 to 6 months to control asthma symptoms. After 3 to 6 months, if asthma is controlled, patients will take Tezepelumab for an additional 6 months plus 18 months of Acarizax.

Drug: Tezepelumab; Drug: Acarizax

Tezepelumab + Placebo

PLACEBO COMPARATOR

Participants will receive Tezepelumab for 3 to 6 months to control asthma symptoms. After 3 to 6 months, if asthma is controlled, patients will take Tezepelumab for an additional 6 months plus 18 months of Placebo.

Drug: Tezepelumab; Drug: Placebo

Interventions

Tezepelumab DRUG

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

Also known as: Tezspire

Tezepelumab + Acarizax; Tezepelumab + Placebo

Acarizax DRUG

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

Tezepelumab + Acarizax

Placebo DRUG

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

Tezepelumab + Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Montpellier: lead
• AstraZeneca: collaborator
• ALK-Abelló A/S: collaborator
• University hospital of Nîmes: collaborator
• ThermoFisher Scientific Brahms Biomarkers France: collaborator

Related Publications (14)

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MeSH Terms

Conditions

Asthma; Dust Mite Allergy

Interventions

tezepelumab

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Rhinitis, Allergic, Perennial; Rhinitis, Allergic; Rhinitis; Nose Diseases; Otorhinolaryngologic Diseases

Study Officials

• Davide CAIMMI, MD, PhD

  University Hospital, Montpellier

  STUDY DIRECTOR

Central Study Contacts

Davide CAIMMI, MD, PhD

CONTACT

+33 4 67 33 61 03; dp-caimmi@chu-montpellier.fr

Amelie DENOUEL, CRA

CONTACT

+33 4 67 33 55 72; a-denouel@chu-montpellier.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Acarizax and placebo tablets will be reconstituted in the same shape.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Once asthma symptoms are controlled (from D0), patients will receive: * Group A: 6 months of Tezepelumab and 18 months of Acarizax * Group B: 6 months of Tezepelumab and 18 months of Placebo

Study Record Dates

• First Submitted: May 15, 2025
• First Posted: June 10, 2025
• Study Start: July 15, 2025
• Primary Completion (Estimated): August 18, 2029
• Study Completion (Estimated): August 18, 2029
• Last Updated: June 10, 2025

Record last verified: 2025-06