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
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Stallergenes Greer
- Enrollment
- 1,607
- Locations
- 4
- Primary Endpoint
- Total Combined Score
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 12 Years to 65 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
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
Arms & Interventions
300 IR
300 IR tablet of HDM Allergen Extracts
Intervention: 300 IR (Biological)
Placebo
Placebo tablet
Intervention: Placebo (Biological)
Outcomes
Primary Outcomes
Total Combined Score
Time Frame: 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 Outcomes
- Average Rescue Medication Score (RMS)(12 months)
- Average Rhinitis Total Symptom Score (RTSS)(12 months)