Efficacy and Safety of STG320 Sublingual Tablets of House Dust Mite (HDM) Allergen Extracts in Adults and Adolescents With HDM-associated Allergic Rhinitis
| Status: | Completed |
|---|---|
| Conditions: | Allergy |
| Therapuetic Areas: | Otolaryngology |
| Healthy: | No |
| Age Range: | 12 - 65 |
| Updated: | 9/13/2018 |
| Start Date: | September 29, 2015 |
| End Date: | June 21, 2018 |
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 is 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.
with 300 IR of STG320 sublingual tablets compared with placebo in adults and adolescents with
HDM-associated allergic rhinitis.
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
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