House Dust Mite Allergy Trial In Children

Phase 3

Completed

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

Registration Number: NCT04145219

Lead Sponsor: ALK-Abelló A/S

Brief 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)

Detailed 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1460

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Average Daily Total Combined Rhinitis Symptom and Medication Score (TCRS) During the Primary Efficacy Assessment Period	8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of IMP	The primary endpoint in the trial was the average daily total combined rhinitis symptoms and medication score (TCRS) during the primary efficacy assessment period. The average daily TCRS evaluates the treatment effect based on the reduction in daily rhinitis symptoms and medication score (on a scale of 0-24). Higher scores indicate more severe symptoms and/or more use of rhinitis medication. The endpoint is calculated as the average score of all reported daily values during the 8-week primary efficacy assessment period. For example, if a subject reported 56 daily TCRS values, the primary endpoint is calculated as the average of those values.

Secondary Outcome Measures

Name	Time	Method
The Average Rhinoconjunctivitis Daily Medication Score (DMS) During the Primary Efficacy Assessment Period	8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of IMP	Average rhinoconjunctivitis DMS evaluates the treatment effect based on the reduction in daily rhinoconjunctivitis medication use (on a scale of 0-20). Higher scores indicate more medication use. The endpoint is calculated as the average score of all reported daily values during the 8-week primary efficacy assessment period. For example, if a subject reported 56 rhinoconjunctivitis DMS values, the endpoint is calculated as the average of those values.
Overall Paediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) Score at the End of Trial	Week leading up to visit 7 (at the end of the primary efficacy assessment period, after approximately 52-57 weeks of treatment)	The overall PRQLQ score measures the effect of rhinoconjunctivitis on participant's quality of life on a scale of 0-6. Higher scores indicate worse rhinoconjunctivitis-related quality of life.
Rhinitis Exacerbation Days During the Primary Efficacy Assessment Period	8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of IMP	The endpoint rhinitis exacerbation days evaluates the treatment effect based on days when participants have severe symptoms. The higher the proportion of rhinitis mild days the higher the estimated probability of a participant having a rhinitis exacerbation day.
The Average Rhinitis Daily Symptom Score (DSS) During the Primary Efficacy Assessment Period	8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of IMP	The average rhinitis DSS evaluates the treatment effect based on the reduction in daily rhinitis symptom score (on a scale of 0-12). Higher scores indicate more severe symptoms. The endpoint is calculated as the average score of all reported daily values during the 8-week primary efficacy assessment period. For example, if a subject reported 56 rhinitis DSS values, the endpoint is calculated as the average of those values.
The Average Daily Total Combined Rhinoconjunctivitis Symptom and Medication Score (TCS) During the Primary Efficacy Assessment Period	8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of IMP	Average rhinoconjunctivitis TCS evaluates the treatment effect based on the reduction in daily rhinoconjunctivitis symptoms and medication use (on a scale of 0-38). Higher scores indicate more severe symptoms and/or more medication use. The endpoint is calculated as the average score of all reported daily values during the 8-week primary efficacy assessment period. For example, if a subject reported 56 daily TCS values, the endpoint is calculated as the average of those values.
Weekly Number of Puffs of As-needed SABA Use During the Primary Efficacy Assessment Period	8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of IMP	Average weekly number of puffs of as-needed SABA use evaluates the treatment effect based on the reduction in the use of asthma reliever medication (SABA), and is calculated as 7 times the average of the daily number of puffs of as-needed SABA use. Higher values indicate more medication use.
The Average Rhinitis Daily Medication Score (DMS) During the Primary Efficacy Assessment Period	8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of IMP	Average rhinitis DMS evaluates the treatment effect based on the reduction in daily rhinitis medication use (on a scale of 0-12). Higher scores indicate more medication use. The endpoint is calculated as the average score of all reported daily values during the 8-week primary efficacy assessment period. For example, if a subject reported 56 rhinitis DMS values, the endpoint is calculated as the average of those values.
The Average Rhinoconjunctivitis Daily Symptom Score (DSS) During the Primary Efficacy Assessment Period	8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of IMP	The average rhinoconjunctivitis DSS evaluates the treatment effect based on the reduction in daily rhinoconjunctivitis symptom score (on a scale of 0-18). Higher scores indicate more severe symptoms. The endpoint is calculated as the average score of all reported daily values during the 8-week primary efficacy assessment period. For example, if a subject reported 56 rhinoconjunctivitis DSS values, the endpoint is calculated as the average of those values.
Average Rhinitis Combined Symptom and Medication Score (CSMS) During the Primary Efficacy Assessment Period	8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of IMP	Average rhinitis CSMS evaluates the treatment effect based on the reduction in daily rhinitis symptoms and/or medication use. For this endpoint, the rhinitis symptoms and medication use were scored using an alternative method as recommended by EAACI (European Academy of Allergy \& Clinical Immunology) (on a scale of 0-5). Higher scores indicate more severe symptoms and/or more medication use. The endpoint is calculated as the average score of all reported daily values during the 8-week primary efficacy assessment period. For example, if a subject reported 56 rhinitis CSMS values, the endpoint is calculated as the average of those values.
Total IgE	Change from screening to the end of trial (after approximately 52-57 weeks of treatment)	The change in total IgE was measured from screening to the end of trial.
House Dust Mite IgE-Blocking Factor	Change from screening to the end of trial (after approximately 52-57 weeks of treatment)	The IgE-blocking factor assesses the effect of serum components (including IgE-blocing antibodies known to be induced by allergy immunotherapy) competing with IgE for binding to allergen. IgE-blocking factor is calculated as 1-(S/T), where S is the amount of allergen-specific IgE bound to allergen in the (possible) presence of competing components, and where T is the total amount of allergen-specific IgE capable of binding to allergen when all competing antibodies/components have been washed off. IgE-blocking factor values closer to 0 indicate the presence of fewer IgE-blocking components and values closer to 1 indicate that more IgE is blocked from binding to the allergen.
The Average Asthma Daily Symptom Score (DSS) During the Primary Efficacy Assessment Period	8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of IMP	The average asthma DSS evaluates the treatment effect based on the reduction in daily asthma symptom score (on a scale of 0-12). Higher scores indicate more severe symptoms. The endpoint is calculated as the average score of all reported daily values during the 8-week primary efficacy assessment period. For example, if a subject reported 56 asthma DSS values, the endpoint is calculated as the average of those values.
Average Rhinoconjunctivitis Combined Symptom and Medication Score (CSMS) During the Primary Efficacy Assessment Period	8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of IMP	Average rhinoconjunctivitis CSMS evaluates the treatment effect based on the reduction in daily rhinoconjunctivitis symptoms and/or medication use. For this endpoint, the rhinoconjunctivitis symptoms and medication use were scored using an alternative method as recommended by EAACI (European Academy of Allergy \& Clinical Immunology) (on a scale of 0-5). Higher scores indicate more severe symptoms and/or more medication use. The endpoint is calculated as the average score of all reported daily values during the 8-week primary efficacy assessment period. For example, if a subject reported 56 rhinoconjunctivitis CSMS values, the endpoint is calculated as the average of those values.
House Dust Mite Specific IgE	Change from screening to the end of trial (after approximately 52-57 weeks of treatment)	House dust mite specific IgE reflects the allergen-specific allergy immunotherapy-induced immune modulation
SABA Free Days During the Primary Efficacy Assessment Period	8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of IMP	The endpoint SABA free days evaluates the treatment effect based on the reduction in SABA use. The higher the proportion of SABA free days the higher the estimated probability of a participant having a day where they didn't use SABA.
Rhinitis Mild Days During the Primary Efficacy Assessment Period	8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of IMP	The endpoint rhinitis mild days evaluates the treatment effect based on days when participants have no symptoms or mild symptoms and no medication use. The higher the proportion of rhinitis mild days the higher the estimated probability of a participant having a rhinitis mild day.
House Dust Mite Specific IgG4	Change from screening to the end of trial (after approximately 52-57 weeks of treatment)	House dust mite specific IgG4 reflects the allergen-specific allergy immunotherapy-induced immune modulation

Trial Locations

Locations (110): Allergy & Asthma Specialists Medical Group and Research Center
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Huntington Beach, California, United States
California Allergy and Asthma Medical Group
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Los Angeles, California, United States
Allergy & Asthma Medical Group and Research Center, A P.C.
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San Diego, California, United States
Miami Clinical Research
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Miami, Florida, United States
Pensacola Research Consultants, Inc. d.b.a. Avanza Medical Research Center
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Pensacola, Florida, United States
GCP, Global Clinical Professionals
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Saint Petersburg, Florida, United States
Sarasota Clinical Research
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Sarasota, Florida, United States
Aeroallergy Research Labs of Savannah, Inc.
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Savannah, Georgia, United States
Clinical Research Atlanta
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Stockbridge, Georgia, United States
Deaconess Clinic Allergy
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Evansville, Indiana, United States
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Allergy & Asthma Specialists Medical Group and Research Center
🇺🇸Huntington Beach, California, United States