NCT02443805

Efficacy & Safety of STG320 Sublingual Tablets of HDM Allergen Extracts in Adults and Adolescents With HDM-associated AR

A Randomized, Double-blind, Placebo-controlled, Multi-center Study of the Efficacy and Safety of STG320 Sublingual Tablets of House Dust Mite (HDM) Allergen Extracts in Adults and Adolescents With HDM-associated Allergic Rhinitis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,607 (actual)
• Sponsor: Stallergenes Greer · Industry
• Sex: All
• Age: 12 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study was to assess the efficacy and safety of 12 months of treatment with 300 IR of STG320 sublingual tablets compared with placebo in adults and adolescents with HDM-associated allergic rhinitis.

Detailed description

This study was a randomized, double-blind, placebo-controlled, phase III study with 2 parallel arms in adults and adolescents with HDM-associated allergic rhinitis (AR) for at least one year. The primary objective was to assess the efficacy of STG320 sublingual tablets at a daily dosage of 300 IR when administered for 12 months to adults and adolescents with HDM-associated AR. The primary efficacy variable was the average Total Combined Score.

Conditions

• Rhinitis, Allergic, Perennial
• House Dust Mite Allergy

Interventions

Type	Name	Description
BIOLOGICAL	300 IR	300 IR tablet of HDM Allergen Extracts
BIOLOGICAL	Placebo	Placebo tablet

Timeline

• Start date: 2015-09-29
• Primary completion: 2018-06-25
• Completion: 2018-06-25
• First posted: 2015-05-14
• Last updated: 2019-10-14
• Results posted: 2019-09-25

Locations

2 sites across 2 countries: United States, France