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Severe AsthmaPhase 3TEZEPAITNCT07013123

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

A Phase 3 study testing Tezepelumab and Acarizax in people with Severe Asthma and Allergy to House Dust Mites, run by University Hospital, Montpellier.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Severe Asthma, Allergy to House Dust Mites
What is being tested?
Tezepelumab and Acarizax
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
38 participants
Where
No sites listed yet
Study dates
15 Jul 2025to 18 Aug 2029
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
Show all 20Show fewer
  • 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.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

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

About this study

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.

Read more

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).

Read the detailed description

The TEZEPAIT study is a prospective, multicentre, 2-parallel-arms, placebo-controlled, double-blind, randomized (1:1) trial.

PHASE 1: Patients will be included in the study after verification of eligibility criteria and signing of informed consent. All patients will be treated with Tezepelumab for 3-6 months and randomized in two groups:

  • Group A: Tezepelumab + Acarizax®
  • Group B: Tezepelumab + Placebo If patients are not controlled (ACT ≥ 20/25) after 3 months of Tezepelumab, they will be re-assessed monthly, for 3 consecutive months, until asthma symptoms are controlled or they will be excluded from the rest of the study. If they are not controlled after 6 months, they will be excluded from the study.

PHASE 2: After the phase 1, if asthma symptoms are controlled (Asthma Control Test, ACT ≥20/25), patients in Group A will start Acarizax®, in addition to Tezepelumab, while patients in Group B will continue Tezepelumab plus a placebo. Patients will all receive a 6-month treatment of Acarizax® or placebo, before stopping Tezepelumab (M6), to assure an optimal effect of AIT, as shown in Phase 3 trials.

Patients will all receive an additional 6 months of Tezepelumab starting at D0 (Start of Acarizax®/placebo), before stopping it.

PHASE 3: After stopping Tezepelumab, patients will receive an additional 12-month treatment of Acarizax® or placebo. Patients will receive an 18-month course of Acarizax® or placebo.

For safety and ethical reasons, between M6 and M18 (Tezepelumab treatment will be suspended), in case of reappearance of uncontrolled severe asthma, Tezepelumab will be re-prescribed to patients.

At the end of the study, patients on placebo, if their asthma is controlled, will be offered Acarizax® treatment (as a regular prescription and paid / reimbursed as proposed by the National French HealthCare system) and patients on Acarizax® treatment and controlled will be able to continue it as routine care.

Being tested
Tezepelumab, Acarizax, Placebo
Keywords
Asthma, Dust Mite Allergy, Allergen immunotherapy
Medical subject headings
Asthma, Dust Mite Allergy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TezepelumabDrug

    Also called Tezspire

    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

  • AcarizaxDrug

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

  • PlaceboDrug

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

Study groups in NCT07013123
Study groupRoleWhat they receive
Tezepelumab + AcarizaxExperimentalParticipants 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.
Receives: Drug: Tezepelumab; Drug: Acarizax
Tezepelumab + PlaceboPlacebo comparatorParticipants 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.
Receives: Drug: Tezepelumab; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Between Day 0 and Month 18

Secondary outcomes (14)

  1. Annualized total number of asthma exacerbations without Tezepelumab

    The number of asthma exacerbations will be recorded by the participant in their follow-up diary throughout the entire trial. Month 6 marks the end of Tezepelumab treatment, and Month 18 marks the end of Acarizax/placebo treatment.

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

  2. ACT score

    The primary purpose of the Asthma Control Test is to provide a systematic way to evaluate how well a patient's asthma is controlled. The test consists of 5 questions that cover different aspects of asthma control (Frequency of symptoms, limitations on Activities, Nighttime Symptoms, Need for rescue Medication, Self-Assessment). Each question is crafted to elicit information on the patient's experience over the past 4 weeks. The possible scores for each question range from 1 to 5. The total score can range from 5 to 25. A 2-points increase in the score has been proven to be statistically significant.

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

  3. ARCT score only for patients suffering from allergic rhinitis

    This test has been validated for assessing allergic rhinitis control and identifying severe allergic rhinitis. The test consists of 5 questions that cover different aspects of allergic rhinitis (Impact on daily life, Quality of life, Nighttime Symptoms, Need for rescue Medication, Self-Assessment). Each question is crafted to elicit information on the patient's experience over the past 2 weeks. The total score can range from 5 to 25. A 2-points increase in the score has been proven to be statistically significant.

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

  4. Forced Expiratory Volume (FEV1)

    Spirometry result: Forced Expiratory Volume in 1 second (L).

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

  5. Forced vital capacity (FVC)

    Spirometry result: Forced Vital Capacity (L).

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

  6. Modified Tiffeneau-Pinelli index

    Spirometry result: FEV₁/FVC ratio (%).

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

  7. Rate of Eosinophils

    Rate of Eosinophils in peripheral blood (Cells/µL)

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

  8. Total and Specific IgE levels

    Serum levels of total and specific IgE (kU/L)

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

  9. Specific IgG4 levels

    Serum levels of Specific IgG4 (kU/L)

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

  10. Eosinophil-Derived Neurotoxin (EDN) levels

    Serum levels of eosinophil-derived neurotoxin (ng/mL)

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

  11. Cytokines IL-4, IL-5, IL-13

    Serum levels of IL-4, IL-5 and IL-13 (pg/mL)

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

  12. SGRQ score

    The SGRQ is a 50-item questionnaire developed to measure health status (quality of life) in patients with diseases if airways obstruction.

    It has two parts:

    • Part I (8 Symptoms items): Several scales
    • Part II (8 sections on Activity and Impacts): Dichotomous (true/false) except last question (4-point Likert scale) Scores are calculated for 3 domains: Symptoms, Activity and Impacts (Psycho-social) as well as a total score. Scores range from 0 to 100, with higher scores indicating more limitations.

    A minimum change in score of 4 units was established as clinically relevant after patient and clinician testing.

    Measured: Month 3, Month 6, Month 9, Month 12 and Month 18

  13. GIRERD questionnaire score

    This questionnaire evaluate treatment adherence. The investigator asks 6 yes/no questions, or the patient answers them independently. "Yes" = 1 point, "No" = 0 points. Total score: 0 to 6.

    Measured: Month 3, Month 6, Month 9, Month 12 and Month 18

  14. Adverse events attributable to Tezspire® or Acarizax®

    All adverse events will be collected to assess their causality in relation to experimental and/or auxiliary treatments.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jun 2025
  2. Study start15 Jul 2025 (estimated)
  3. Primary completion18 Aug 2029 (estimated)
  4. Study completion18 Aug 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
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
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
38 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07013123
Sponsor's protocol ID
RECHMPL25_0069
Other IDs
2025-521258-41-00, 2025
Acronym
TEZEPAIT
Status last verified
Jun 2025
First submitted
15 May 2025
Last updated
10 Jun 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Seys SF, Scheers H, Van den Brande P, Marijsse G, Dilissen E, Van Den Bergh A, Goeminne PC, Hellings PW, Ceuppens JL, Dupont LJ, Bullens DM. Cluster analysis of sputum cytokine-high profiles reveals diversity in T(h)2-high asthma patients. Respir Res. 2017 Feb 23;18(1):39. doi: 10.1186/s12931-017-0524-y.

    PubMed 28231834

  • Lommatzsch M, Brusselle GG, Canonica GW, Jackson DJ, Nair P, Buhl R, Virchow JC. Disease-modifying anti-asthmatic drugs. Lancet. 2022 Apr 23;399(10335):1664-1668. doi: 10.1016/S0140-6736(22)00331-2. No abstract available.

    PubMed 35461560

  • Corren J, Larson D, Altman MC, Segnitz RM, Avila PC, Greenberger PA, Baroody F, Moss MH, Nelson H, Burbank AJ, Hernandez ML, Peden D, Saini S, Tilles S, Hussain I, Whitehouse D, Qin T, Villarreal M, Sever M, Wheatley LM, Nepom GT, Sanda S; Immune Tolerance Network ITN057AD CATNIP Study Team. Effects of combination treatment with tezepelumab and allergen immunotherapy on nasal responses to allergen: A randomized controlled trial. J Allergy Clin Immunol. 2023 Jan;151(1):192-201. doi: 10.1016/j.jaci.2022.08.029. Epub 2022 Oct 9.

    PubMed 36223848

  • Fritzsching B, Contoli M, Porsbjerg C, Buchs S, Larsen JR, Elliott L, Rodriguez MR, Freemantle N. Long-term real-world effectiveness of allergy immunotherapy in patients with allergic rhinitis and asthma: Results from the REACT study, a retrospective cohort study. Lancet Reg Health Eur. 2021 Nov 30;13:100275. doi: 10.1016/j.lanepe.2021.100275. eCollection 2022 Feb.

    PubMed 34901915

  • Corren J, Parnes JR, Wang L, Mo M, Roseti SL, Griffiths JM, van der Merwe R. Tezepelumab in Adults with Uncontrolled Asthma. N Engl J Med. 2017 Sep 7;377(10):936-946. doi: 10.1056/NEJMoa1704064.

    PubMed 28877011

  • Agache I, Rogozea L. Asthma Biomarkers: Do They Bring Precision Medicine Closer to the Clinic? Allergy Asthma Immunol Res. 2017 Nov;9(6):466-476. doi: 10.4168/aair.2017.9.6.466.

    PubMed 28913985

  • Influence of diet on fatty acid composition of red cell and neural membranes. Nutr Rev. 1987 Aug;45(8):246-8. doi: 10.1111/j.1753-4887.1987.tb02690.x. No abstract available.

    PubMed 3306486

  • Gauvreau GM, Sehmi R, Ambrose CS, Griffiths JM. Thymic stromal lymphopoietin: its role and potential as a therapeutic target in asthma. Expert Opin Ther Targets. 2020 Aug;24(8):777-792. doi: 10.1080/14728222.2020.1783242. Epub 2020 Jun 27.

    PubMed 32567399

  • Ziegler SF, Roan F, Bell BD, Stoklasek TA, Kitajima M, Han H. The biology of thymic stromal lymphopoietin (TSLP). Adv Pharmacol. 2013;66:129-55. doi: 10.1016/B978-0-12-404717-4.00004-4.

    PubMed 23433457

  • Pelaia C, Pelaia G, Longhini F, Crimi C, Calabrese C, Gallelli L, Sciacqua A, Vatrella A. Monoclonal Antibodies Targeting Alarmins: A New Perspective for Biological Therapies of Severe Asthma. Biomedicines. 2021 Aug 29;9(9):1108. doi: 10.3390/biomedicines9091108.

    PubMed 34572294

  • Peters MC, Mekonnen ZK, Yuan S, Bhakta NR, Woodruff PG, Fahy JV. Measures of gene expression in sputum cells can identify TH2-high and TH2-low subtypes of asthma. J Allergy Clin Immunol. 2014 Feb;133(2):388-94. doi: 10.1016/j.jaci.2013.07.036. Epub 2013 Sep 24.

    PubMed 24075231

  • Virchow JC, Backer V, Kuna P, Prieto L, Nolte H, Villesen HH, Ljorring C, Riis B, de Blay F. Efficacy of a House Dust Mite Sublingual Allergen Immunotherapy Tablet in Adults With Allergic Asthma: A Randomized Clinical Trial. JAMA. 2016 Apr 26;315(16):1715-25. doi: 10.1001/jama.2016.3964.

    PubMed 27115376

  • Shikotra A, Choy DF, Ohri CM, Doran E, Butler C, Hargadon B, Shelley M, Abbas AR, Austin CD, Jackman J, Wu LC, Heaney LG, Arron JR, Bradding P. Increased expression of immunoreactive thymic stromal lymphopoietin in patients with severe asthma. J Allergy Clin Immunol. 2012 Jan;129(1):104-11.e1-9. doi: 10.1016/j.jaci.2011.08.031. Epub 2011 Oct 5.

    PubMed 21975173

  • Chung KF, Wenzel SE, Brozek JL, Bush A, Castro M, Sterk PJ, Adcock IM, Bateman ED, Bel EH, Bleecker ER, Boulet LP, Brightling C, Chanez P, Dahlen SE, Djukanovic R, Frey U, Gaga M, Gibson P, Hamid Q, Jajour NN, Mauad T, Sorkness RL, Teague WG. International ERS/ATS guidelines on definition, evaluation and treatment of severe asthma. Eur Respir J. 2014 Feb;43(2):343-73. doi: 10.1183/09031936.00202013. Epub 2013 Dec 12.

    PubMed 24337046

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tezepelumab and Acarizax in people with Severe Asthma and Allergy to House Dust Mites, run by University Hospital, Montpellier.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 10 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Davide CAIMMI, MD, PhD (+33 4 67 33 61 03, dp-caimmi@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Annualized total number of asthma exacerbations under acarizax/placebo treatment (time frame: Between Day 0 and Month 18). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07013123, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2025.

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TEZEPAIT Clinical Trial NCT07013123 | AzTrials