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

Stallergenes Greer

Status and phase: Completed; Phase 3

Conditions: House Dust Mite Allergy; Rhinitis, Allergic, Perennial

Treatments: Biological: 300 IR; Biological: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02443805

SL75.14

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,607 patients

Sex: All

Ages: 12 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,607 participants in 2 patient groups, including a placebo group

300 IR

Active Comparator group

Description:

300 IR tablet of HDM Allergen Extracts

Treatment:

Biological: 300 IR

Placebo

Placebo Comparator group

Description:

Placebo tablet

Treatment:

Biological: Placebo