Evaluating a treatment for allergies to dust mites
Official title: 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
Run by Inmunotek S.L. · NCT04435990 · Data updated 2026-11-12
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
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 12 Years to 65 Years |
| Sex | All |
| Enrollment | 150 (estimated) |
| Sponsor | Inmunotek S.L. Industry-sponsored |
| Drugs / interventions | immunotherapy |
| Locations | 32 sites (Santiago de Compostela, A Coruña and 31 other locations) |
| Status | Recruiting |
| Started | October 6, 2020 |
| Main results expected | December 2026 |
| Study ends | December 2026 |
| Registry record updated | May 13, 2025 |
| Trial ID | NCT04435990 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals aged 12 to 65 with a confirmed history of inhalant allergy to Dermatophagoides pteronyssinus and/or Dermatophagoides farinae.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Previous studies have shown promise in using immunotherapy for dust mite allergies, indicating that this approach is supported by existing research.
Who can join: the full rules
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 it's running
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Hospital Provincial de Conxo
Santiago de Compostela, A Coruña, Spain Recruiting -
IMED Elche
Elche, Alicante, Spain Recruiting -
Hospital Universitario de Torrevieja
Torrevieja, Alicante, Spain Recruiting -
Hospital Dr. Peset
Valencia, España, Spain Recruiting -
Hospital General Universitario Dr. Balmis
Alicante, Spain Recruiting -
Hospital Universitario San Juan de Alicante
Alicante, Spain Recruiting
Show 26 more locations
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Clínica Dermatológica y Alergia
Badajoz, Spain Recruiting -
Hospital Quironsalud Clideba
Badajoz, Spain Recruiting -
Hospital Sant Pere Claver
Barcelona, Spain Recruiting -
Clínica Corachan
Barcelona, Spain Recruiting -
Hospital Universitari Dexeus
Barcelona, Spain Recruiting -
Cenvi Medic
Barcelona, Spain Recruiting -
Centro Médico ASISA Dr. Lobatón
Cadiz, Spain Recruiting -
Centro Médico Puerto
Cadiz, Spain Recruiting -
Hospital Quiron Salud Córdoba
Córdoba, Spain Recruiting -
Hospital Polusa
Lugo, Spain Recruiting -
Clinica privada
Málaga, Spain Recruiting -
Hospital Comarcal de Melilla
Melilla, Spain Recruiting -
Alergocantabria
Santander, Spain Recruiting -
Hospital Quiron Infanta Luisa
Seville, Spain Recruiting -
Clinica Lanuza
Valencia, Spain Recruiting -
Hospital Universitario Y Politecnico La Fe
Valencia, Spain Recruiting -
Clinica Tecma
Valencia, Alzira, Spain Completed -
Clinica Virgen del Rosario
Algeciras, Cadiz, Spain Active not recruiting -
Hospital HLA Jerez Puerta Sur
Jerez de la Frontera, Cádiz, Spain Withdrawn -
Hospital General Universitario Santa Maria de Rosell
Cartagena, Murcia, Spain Withdrawn -
Hospital Rivera Povisa
Vigo, Pontevedra, Spain Active not recruiting -
Allergocenter
Barcelona, Spain Active not recruiting -
Clinica privada
Bilbao, Spain Withdrawn -
Clinica Privada
Murcia, Spain Not yet recruiting -
Clinica IMED
Valencia, Spain Withdrawn -
Hospital de Sagunto
Valencia, Spain Withdrawn
Study contacts
- Study coordinator: Miguel Casanovas, MD PhD
- Email: mcasanovas@inmunotek.com
- Phone: +34916510010
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.