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

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.

Study Overview

• Status: Completed
• Conditions: Rhinitis, Allergic, Perennial; House Dust Mite Allergy
• Intervention / Treatment: Biological: 300 IR; Biological: Placebo

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 Type: Interventional
• Enrollment (Actual): 1607
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • CHU Arnaud de Villeneuve
• United States
  • Florida
    • Tampa, Florida, United States, 33610
      • University of South of Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Main 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Placebo tablet	Biological: Placebo; Placebo tablet
Active Comparator: 300 IR; 300 IR tablet of HDM Allergen Extracts	Biological: 300 IR; 300 IR tablet of HDM Allergen Extracts

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Combined Score	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.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average Rhinitis Total Symptom Score (RTSS)	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.	12 months
Average Rescue Medication Score (RMS)	Average RMS during the primary evaluation period. Rescue Medication Score (RMS) ; range 0-3, lower is better.	12 months

Collaborators and Investigators

• Sponsor: Stallergenes Greer
• Investigators: Principal Investigator: Tom Casale, MD, University of South of Florida, Tampa, USA

Study record dates

Study Major Dates

• Study Start (Actual): September 29, 2015
• Primary Completion (Actual): June 25, 2018
• Study Completion (Actual): June 25, 2018

Study Registration Dates

• First Submitted: April 29, 2015
• First Submitted That Met QC Criteria: May 13, 2015
• First Posted (Estimate): May 14, 2015

Study Record Updates

• Last Update Posted (Actual): October 14, 2019
• Last Update Submitted That Met QC Criteria: September 26, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial
• Other Study ID Numbers: SL75.14