House Dust Mite Allergy Trial In Children (MATIC)

ALK-Abelló

Status and phase: Completed; 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: 1,460 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 (Allergic rhinitis/rhinoconjunctivitis) (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 (Allergic rhinitis) 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 (Immunoglobulin E) 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

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1,460 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