Mite Allergy Trial In Children (MATIC)

  • STATUS
    Recruiting
  • End date
    Apr 9, 2023
  • participants needed
    1370
  • sponsor
    ALK-Abelló A/S
Updated on 21 February 2022

Summary

A research study of how house dust mite tablets work compared to placebo in children aged between 5 and 11 years and who have allergy to house dust mites (MATIC)

Description

The trial aims to demonstrate efficacy of the House Dust Mite SLIT-tablet compared to placebo in children (5-11 years of age) with House Dust Mite allergic rhinitis based on the total combined rhinitis symptoms and medication score during the last 8 weeks of treatment.

In addition, the trial will evaluate safety and tolerability of the treatment, and assess whether treatment has an impact on asthma symptoms and medication use, immunological parameters, and rhinoconjunctivitis quality of life (QoL).

The trial is a randomised, parallel-group, double-blind, placebo-controlled multi-national phase III trial conducted in Europe and North America. The treatment period will be approximately 1 year.

Details
Condition Allergic Rhinitis Due to Dermatophagoides Farinae, Allergic Rhinitis Due to Dermatophagoides Pteronyssinus, Allergic Rhinitis Due to House Dust Mite
Treatment Placebo, Sublingual allergy immunotherapy tablet
Clinical Study IdentifierNCT04145219
SponsorALK-Abelló A/S
Last Modified on21 February 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Male or female subjects aged 5-11 years
A clinical history of HDM AR/C (with or without asthma) and with allergic rhinitis symptoms despite having received allergy pharmacotherapy during the previous year prior to screening
Have a certain level of AR symptoms on at least 8 of the last 14 days of the baseline period
Use symptomatic medication for treatment of HDM allergic rhinitis during at least 8 of the last 14 days of the baseline period
Positive skin prick test (SPT) and IgE to D. pteronyssinus or D. farinae at screening
Lung function 70% of predicted value

Exclusion Criteria

Sensitised and regularly exposed to perennial allergens
Any nasal or pharyngeal condition that could interfere with the safety or efficacy evaluation
Asthma requiring treatment with high dose of inhaled corticosteroid
A relevant history of systemic allergic reaction
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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