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

Phase 3

Completed

• Conditions: Rhinitis, Allergic, Perennial; House Dust Mite Allergy
• Interventions: Biological: 300 IR; Biological: Placebo

• Registration Number: NCT02443805
• Lead Sponsor: Stallergenes Greer

Brief 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.

Study Timeline

• Study First Submitted: 2015-04-29
• Study First Submitted QC: 2015-05-13
• Study First Posted: 2015-05-14
• Study Start: 2015-09-29
• Primary Completion: 2018-06-25
• Study Completion: 2018-06-25
• Results First Submitted: 2019-08-29
• Status Verified: 2019-09
• Results First Submitted QC: 2019-09-03
• Results First Posted: 2019-09-25
• Last Update Submitted: 2019-09-26
• Last Update Posted: 2019-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1607

Inclusion Criteria

• Patients with HDM-associated allergic rhinitis (AR) for at least 1 year
• Patients sensitized to D. pteronyssinus (D. pte) and/or D. farinae (D. far) defined on skin prick test and HDM-specific serum IgE

Main

Exclusion Criteria

• A history of rhinitis, rhinoconjunctivitis or asthma to allergens other than HDM, likely to result in rhinitis symptoms during the evaluation periods
• Partly controlled or uncontrolled asthma
• Controlled asthma requiring controller treatment(s) consistent with GINA 2014 treatment Steps 3 to 5

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
300 IR	300 IR	300 IR tablet of HDM Allergen Extracts
Placebo	Placebo	Placebo tablet

Primary Outcome Measures

Name	Time	Method
Total Combined Score	12 months	Average Total Combined Score (TCS), calculated for each patient as the average of the non-missing daily TCSs during the primary evaluation period. The daily TCS (scale 0-15) was the sum of the patient's daily Rhinitis Total Symptom Score (RTSS, scale 0-12) and daily Rescue Medication Score (RMS, scale 0-3). Lower is better.

Secondary Outcome Measures

Name	Time	Method
Average Rescue Medication Score (RMS)	12 months	Average RMS during the primary evaluation period. Rescue Medication Score (RMS) ; range 0-3, lower is better.
Average Rhinitis Total Symptom Score (RTSS)	12 months	Average RTSS during the primary evaluation period. The daily Total Symptom Scores (RTSS) was the sum of the 4 rhinitis symptom scores: sneezing, rhinorrhoea, nasal pruritus and nasal congestion, each graded on a 4-point scale (0-3; 0: absent, 1: mild, 2: moderate, 3: severe).; It ranges from 0 to 12. Lower is better.

Trial Locations

Locations (2)

CHU Arnaud de Villeneuve; 🇫🇷 Montpellier, France

University of South of Florida; 🇺🇸 Tampa, Florida, United States