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

Rhinitis, Allergic, Perennial Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02443805
• Other study ID #: SL75.14
• Status: Completed
• Phase: Phase 3
• Start date: September 29, 2015
• Est. completion date: June 25, 2018

Study information

• Verified date: September 2019
• Source: Stallergenes Greer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1607
• Est. completion date: June 25, 2018
• Est. primary completion date: June 25, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• House Dust Mite Allergy
• Rhinitis
• Rhinitis, Allergic
• Rhinitis, Allergic, Perennial

Intervention

Biological:
• 300 IR
300 IR tablet of HDM Allergen Extracts
• Placebo
Placebo tablet

Locations

Country	Name	City	State
France	CHU Arnaud de Villeneuve	Montpellier
United States	University of South of Florida	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Stallergenes Greer

Countries where clinical trial is conducted

United States,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Average Rescue Medication Score (RMS)	Average RMS during the primary evaluation period. Rescue Medication Score (RMS) ; range 0-3, lower is better.	12 months