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Recruiting Phase 3

Efficacy and Safety Evaluation for the Treatment of Allergy Against Mites

NCT04435990 · tracked via the Priya Life Science Spain tracker
Phase
Phase 3
Started
2020-10-06
Last updated
2025-05-13

Condition(s) studied

Rhinitis, AllergicRhinoconjunctivitisAsthma, Allergic

Investigational drug(s) / intervention(s)

10,000 MM0930,000 MM09Placebo subcutaneous

10,000 MM09: Purified allergenic extract, and adsorbed in aluminum hydroxide and polymerized with glutaraldehyde, mite mixture (Dermatophagoides pteronyssinus and Dermatophagoides farinae) with a concentration of 10,000 UT / mL

30,000 MM09: Purified allergenic extract, and adsorbed in aluminum hydroxide and polymerized with glutaraldehyde, mite mixture (Dermatophagoides pteronyssinus and Dermatophagoides farinae). The concentration is 30,000 UT / mL

Placebo subcutaneous: The same solution and presentation as the active treatment, but without active ingredients.

Study summary

A double-blinded, placebo-controlled, prospective, multicenter randomized of 2 active treatment groups, compared to 1 placebo group, for the determination of the efficacy and safety of subcutaneous immunotherapy in patients with rhinitis/rhinoconjunctivitis with or without asthma, sensitised to Dermatophagoides pteronyssinus and /or Dermatophagoides farinae.

Eligibility

Sex
ALL
Min age
12 Years
Max age
65 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • CSMS: Combined Symptoms and Medication Score — 12 months
    Evaluation of the number of symptoms and the consumption of medication for symptoms rhinitis / rhinoconjunctivitis of each subject during the trial, of the groups with each other and with respect to placebo.

Trial sites (32)

FacilityCityRegionStatus
Hospital Provincial de Conxo Santiago de Compostela A Coruña Recruiting
IMED Elche Elche Alicante Recruiting
Hospital Universitario de Torrevieja Torrevieja Alicante Recruiting
Clinica Tecma Valencia Alzira Completed
Clinica Virgen del Rosario Algeciras Cadiz Active Not Recruiting
Hospital HLA Jerez Puerta Sur Jerez de la Frontera Cádiz Withdrawn
Hospital Dr. Peset Valencia España Recruiting
Hospital General Universitario Santa Maria de Rosell Cartagena Murcia Withdrawn
Hospital Rivera Povisa Vigo Pontevedra Active Not Recruiting
Hospital General Universitario Dr. Balmis Alicante Spain Recruiting
Hospital Universitario San Juan de Alicante Alicante Spain Recruiting
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
Allergocenter Barcelona Spain Active Not Recruiting
Clinica privada Bilbao Spain Withdrawn
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
Clinica Privada Murcia Spain Not Yet 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 IMED Valencia Spain Withdrawn
Hospital de Sagunto Valencia Spain Withdrawn
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04435990 on ClinicalTrials.gov ↗ ← All trials in Spain