Clinical Trial Details

Overview

Research Study Summary

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

Purpose

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.

To Learn more

CW ID: 212081
Date Last Changed: December 4, 2015

Clinical Trial Snapshot

Phase
3
Gender
Both Male and Female
Age
12 to 65 Years
Overall Status
Recruiting
Lead Sponsor
Stallergenes
Duration
12 Months
Facility Type
Out-Patient

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

More Info

Protocol number: SL75.14

Contact

Renee Smith
University of South Florida- Asthma, Allergy, and Immunology Clinical Research Unit
13801 Bruce B. Downs Blvd. #502
Tampa, FL 33613
Phone: 813-631-4024

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