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

NCT02443805 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1607

Last updated 2019-10-14

Study results available
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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.

Conditions

  • Rhinitis, Allergic, Perennial
  • House Dust Mite Allergy

Interventions

BIOLOGICAL

300 IR

300 IR tablet of HDM Allergen Extracts

BIOLOGICAL

Placebo

Placebo tablet

Sponsors & Collaborators

  • Stallergenes Greer

    lead INDUSTRY

Principal Investigators

  • Pascal Demoly, MD · CHU Arnaud de Villeneuve, Montpellier, France

  • Tom Casale, MD · University of South of Florida, Tampa, USA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-29
Primary Completion
2018-06-25
Completion
2018-06-25

Countries

  • United States
  • France

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02443805 on ClinicalTrials.gov