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Evaluating a treatment for allergies to dust mites

Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled, Efficacy and Safety Clinical Trial With SCIT in Patients With Rhinitis/Rhinoconjunctivitis With or Without Mild to Moderate Asthma Sensitized to Dpt. and/or D. Farinae

Phase 3 Interventional Inmunotek S.L. · NCT04435990

This study is testing a new allergy treatment for people aged 12 to 65 who are sensitive to dust mites to see if it can help reduce their allergy and asthma symptoms over a year.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment150 (estimated)
Ages12 Years to 65 Years
SexAll
SponsorInmunotek S.L. Industry-sponsored
Drugs / interventionsimmunotherapy
Locations32 sites (Santiago de Compostela, A Coruña and 31 other locations)
Trial IDNCT04435990 on ClinicalTrials.gov

What this trial studies

This clinical trial is a double-blinded, placebo-controlled, multicenter study designed to evaluate the efficacy and safety of subcutaneous immunotherapy in patients aged 12 to 65 who are sensitized to dust mites. It involves two active treatment groups receiving different doses of the medication and one placebo group, with a total of 150 participants. The study aims to determine the impact of the treatment on allergic rhinitis and asthma symptoms over a one-year period.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 12 to 65 with a confirmed history of inhalant allergy to Dermatophagoides pteronyssinus and/or Dermatophagoides farinae.

Not a fit: Patients with allergies not related to dust mites or those outside the age range of 12 to 65 may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce allergy symptoms and improve quality of life for patients suffering from dust mite allergies.

How similar studies have performed: Previous studies have shown promise in using immunotherapy for dust mite allergies, indicating that this approach is supported by existing research.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Written informed consent.
* Age between 12 and 65, both genders.
* Subjects with a confirmed clinical history of inhalant allergy (intermittent or persistent moderate-severe rhinitis and/or rhinoconjunctivitis according to the ARIA classification with or without intermittent or persistent mild-moderate controlled asthma according to the GEMA 5.0 definition) caused by allergy to Dermatophagoides pteronyssinus and/or Dermatophagoides farinae. The diagnosis of asthma will be valid from 12 months prior to signing the informed consent.
* Subjects with a positive skin prick-test wheal size \>5 mm higher diameter due to Dermatophagoides pteronyssinus and/or Dermatophagoides farinae. The positive and negative control of the test should give consistent results. The results will be valid 12 months prior to the signing of the informed consent.
* Specific immunoglobulin E against house dust mites \>3,5 KU/mL (InmunoCAP® o Immulite), for the complete extract of Dermatophagoides pteronyssinus and / or for Dermatophagoides farinae or for some of the molecular components of these allergenic sources
* Subjects should preferably be monosensitized to the study allergens. In case of subjects sensitized to other aeroallergens, only those with the following characteristics may be included in the study:

  * Subjects with positive skin test to Blomia tropicalis and Lepidoglyphus destructor, whose specific IgE values do not exceed or equal the values for the study allergens. The maximum specific IgE value for these allergens is 3.5 KU/L.
  * Subjects with positive skin tests to epithelia, as long as they present occasional exposure and symptomatology.
  * Subjects with positive skin tests to pollens, whose specific IgE values do not exceed or equal the values of the allergens in the study and who do not present exacerbations during the pollen season. The maximum value of specific IgE for these allergens is 17.5 KU/L.
* Subjects with negative skin test for fungi
* Women of childbearing age (from menarche) must present a urine pregnancy test with a negative result at the time of joining the trial, before the first administration of the IMP.
* Women of childbearing age participating in the trial must agree to use an appropriate method of contraception, meaning any act, device, or medication to prevent conception or viable pregnancy, during the trial if they are sexually active.
* Subjects with a diagnosis of asthma according to the GEMA 5.0 guideline.
* Subjects capable of complying with the dosing regimen.
* Subjects who own an smartphone for symptom registration and medication

Exclusion Criteria:

* Subjects who have received previous immunotherapy in the previous 5 years to dander, fungi, and mites.
* Subjects in whom immunotherapy may be subject to an absolute general contraindication according to the criteria of the Immunotherapy Committee of the Spanish Society of Allergy and Clinical Immunology and the European Allergy and Clinical Immunology Immunotherapy Subcommittee.
* Subjects with persistent severe or uncontrolled asthma, with an FEV1\<70% of baseline despite adequate pharmacological treatment at the time of inclusion in the trial. Also subjects with intermittent or persistent rhinitis/rhinoconjunctivitis with severe symptoms in whom oral or systemic antihistamine therapy is contraindicated.
* Subjects who have previously presented a serious secondary reaction during the performance of diagnostic skin tests using the prick test.
* Subjects under treatment with β-blockers.
* Clinically unstable subjects at the time of inclusion in the trial (acute asthma exacerbation, respiratory infection, feverish process, acute urticaria, etc.).
* Subjects with chronic active urticaria, severe dermographism, severe atopic dermatitis, sunburn, active psoriasis with lesions in areas where skin prick test will be performed, or a history of hereditary angioedema.
* Subjects with any other disease not related to moderate rhinoconjunctivitis or asthma, but of potential severity and that may interfere with treatment and follow-up (epilepsy, psychomotor impairment, uncontrolled diabetes, malformations, multiple surgeries, nephropathy).
* Subjects with autoimmune disease (thyroiditis, lupus, etc.), tumor diseases or with a diagnosis of immunodeficiencies.
* Subject whose condition prevents him/her from offering cooperation and/or who has serious mental illness.
* Subjects with a known allergy to other components of the investigational medicinal product other than the allergen.
* Subjects with diseases of the lower respiratory tract other than asthma such as emphysema or bronchiectasis.
* Direct investigator's relatives.
* Pregnant women or breastfeeding women.

Where this trial is running

Santiago de Compostela, A Coruña and 31 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Rhinitis, AllergicRhinoconjunctivitisAsthma, AllergicRhinitis/ RhinoconjunctivitisMild to moderate asthmaAllergyImmunotherapyMites
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.