The trial is taking place at:
K

Kern Research | Bakersfield, CA

Veeva-enabled site

House Dust Mite Allergy Trial In Children (MATIC)

A

ALK-Abelló

Status and phase

Active, not recruiting
Phase 3

Conditions

Allergic Rhinitis Due to House Dust Mite
Allergic Rhinitis Due to Dermatophagoides Pteronyssinus
Allergic Rhinitis Due to Dermatophagoides Farinae

Treatments

Other: Placebo
Biological: Sublingual allergy immunotherapy tablet

Study type

Interventional

Funder types

Industry

Identifiers

NCT04145219
MT-12

Details and patient eligibility

About

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)

Full 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.

Enrollment

1,459 patients

Sex

All

Ages

5 to 11 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

1,459 participants in 2 patient groups, including a placebo group

Active treatment
Experimental group
Description:
HDM SLIT-tablet plus allergy and asthma rescue medication
Treatment:
Biological: Sublingual allergy immunotherapy tablet
Placebo
Placebo Comparator group
Description:
Placebo oral tablet plus allergy and asthma rescue medication
Treatment:
Other: Placebo

Trial contacts and locations

117

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Data sourced from clinicaltrials.gov

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