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Efficacy and Safety Evaluation for the Treatment of Allergy Against Mites | Clinical Trials | Clareo Health

RECRUITINGPHASE3

Efficacy and Safety Evaluation for the Treatment of Allergy Against 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

NCT04435990•Inmunotek S.L.

View on ClinicalTrials.gov

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.

Detailed Description

Double blind, multicenter, parallel placebo controlled study. It includes 150 subjects sensitised to mites, from 12 to 65 years of age. Medication treatment of 1 year. The main outcome: CSMS

Eligibility

Age

12 - 65 years

Sex

ALL

Healthy Volunteers

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
+5 more criteria

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.
+4 more criteria

Locations (32)

Hospital Provincial de Conxo

Santiago de Compostela, A Coruña, Spain

IMED Elche

Elche, Alicante, Spain

Hospital Universitario de Torrevieja

Torrevieja, Alicante, Spain

Clinica Tecma

Valencia, Alzira, Spain

Clinica Virgen del Rosario

Algeciras, Cadiz, Spain

Hospital HLA Jerez Puerta Sur

Jerez de la Frontera, Cádiz, Spain

Hospital Dr. Peset

Valencia, España, Spain

Hospital General Universitario Santa Maria de Rosell

Cartagena, Murcia, Spain

Hospital Rivera Povisa

Vigo, Pontevedra, Spain

Hospital General Universitario Dr. Balmis

Alicante, Spain

Key Dates

Start Date

October 6, 2020

Primary Completion Date

December 1, 2026

Completion Date

December 1, 2026

Last Updated

May 13, 2025

Enrollment

150

ESTIMATED participants

Conditions

Rhinitis, AllergicRhinoconjunctivitisAsthma, Allergic

Interventions

10,000 MM09

BIOLOGICAL

30,000 MM09

BIOLOGICAL

Placebo subcutaneous

BIOLOGICAL

Contacts

Miguel Casanovas, MD PhD

CONTACT

+34916510010 mcasanovas@inmunotek.com

Raquel Caballero, MD

CONTACT

+34607600638 rcaballero@inmunotek.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 13, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Efficacy and Safety Evaluation for the Treatment of Allergy Against Mites

Inclusion Criteria

Exclusion Criteria

A Biorepository of Multiple Allergic Diseases (MADREP) With Longitudinal Follow-Up

Evaluation of the Efficacy of Allergen-specific Immunotherapy Using Assessment in an Allergen Exposure chamber-a Randomized Placebo-controlled Double-blind Study

Study on the Mechanism of ZhenQiFuZheng in the Treatment of Allergic Rhinitis Based on Intestinal Flora and Metabolites

Lung-Resident Memory Th2 Cells in Asthma

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