Safety and Efficacy Study of Sublingual Immunotherapy (SLIT) to Treat House Dust Mite Allergic Rhinitis in Adolescents and Children

Phase 3

Terminated

• Conditions: Allergic Rhinitis Due to Dust Mite
• Interventions: Drug: 300 IR house dust mites allergen extract tablet; Drug: Placebo tablet

• Registration Number: NCT01199133
• Lead Sponsor: Stallergenes Greer

Brief Summary

The purpose of this study is to assess the efficacy of one dose of sublingual immunotherapy (SLIT) administered to children and adolescents as allergen-based tablets once daily over a period of 24 months over 3 years compared to placebo, for reduction of allergic rhinitis symptoms and rescue medication use.

Detailed Description

After the screening period, the patients will be administered 300 IR house dust mite allergen based tablets or placebo, once a day, for a period of 36 months with two windows of 8 months and 6 months without treatment. The carry over effect will be evaluated after a treatment free follow up period of 24 months.

An independent Data Monitoring Committee will be constituted to evaluate the efficacy and safety data at the end of Year 1 and Year 3, and the post-treatment long-term efficacy data at the end of year 4.

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2010-09-09
• Study First Submitted QC: 2010-09-09
• Study First Posted: 2010-09-10
• Primary Completion: 2011-01
• Study Completion: 2011-09
• Results First Submitted: 2024-11-27
• Status Verified: 2025-01
• Results First Submitted QC: 2025-01-23
• Last Update Submitted: 2025-01-23
• Results First Posted: 2025-02-11
• Last Update Posted: 2025-02-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 471

Inclusion Criteria

• Male or female outpatients, aged 5-17 years inclusive
• History of house dust mite-related allergic rhinitis for at least 1 year requiring regular intake of symptomatic treatment(s)
• Sensitised to D. pteronyssinus and/or D. farinae (positive skin prick test with wheal diameter greater than 3 mm and specific IgE level ≥ 0.7 kU/L)

Exclusion Criteria

• Co-sensitization associated with clinically relevant allergic rhinitis, sinusitis, conjunctivitis or asthma likely to significantly change the symptoms of the patient throughout the study (that means patient symptomatic to another allergen than house dust mites to which the patient will be exposed during the study, i.e. will notably be excluded

• patients sensitised to cat or dog allergens and regularly exposed to these allergens
• patients sensitised to aspergillus, cladosporium, alternaria
• patients sensitised to parietaria , ragweed, or mugwort, if this allergen is endemic to the region

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
300 IR	300 IR house dust mites allergen extract tablet	300 IR house dust mites allergen extract tablet
Placebo	Placebo tablet	Placebo tablet

Primary Outcome Measures

Name	Time	Method
Average Adjusted Symptom Score (AASS) During the Treatment Period	Year 1 Primary Period = 01 OCT to 30 NOV 2010 The value was obtained by averaging the daily scores over the primary period	The primary efficacy endpoint was the Average Adjusted Symptom Score (AAdSS) during the period from 1 October 2010 to 30 November 2010 (Year 1 Primary Period) assessed in the Full Analysis Set defined for Year 1. The Average Adjusted Symptom Score (AAdSS) ranges from 0 to 12, with a higher score meaning a worse outcome.; It is a score assessing four rhinitis symptoms: sneezing, rhinorrhoea, nasal pruritus and nasal congestion, adjusted on the rescue medication intake