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Trial record 1 of 1 for:    NCT02443805
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Efficacy and Safety of STG320 Sublingual Tablets of House Dust Mite (HDM) Allergen Extracts in Adults and Adolescents With HDM-associated Allergic Rhinitis

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ClinicalTrials.gov Identifier: NCT02443805
Recruitment Status : Completed
First Posted : May 14, 2015
Last Update Posted : September 11, 2018
Sponsor:
Information provided by (Responsible Party):
Stallergenes Greer

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Rhinitis, Allergic, Perennial House Dust Mite Allergy Biological: 300 IR Biological: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1607 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : September 29, 2015
Actual Primary Completion Date : June 21, 2018
Actual Study Completion Date : June 21, 2018

Arm Intervention/treatment
Active Comparator: 300 IR
300 IR tablet of HDM Allergen Extracts
Biological: 300 IR
300 IR tablet of HDM Allergen Extracts

Placebo Comparator: Placebo
Placebo tablet
Biological: Placebo
Placebo tablet




Primary Outcome Measures :
  1. Total Combined Score [ Time Frame: 12 months ]
    The daily TCS is the sum of the patient's daily Rhinitis Total Symptom Score and daily Rescue Medication Score and will be assessed during 4 weeks at the end of a 12-month treatment duration.


Secondary Outcome Measures :
  1. Adverse events [ Time Frame: 12 months ]
    Safety and tolerability evaluated on adverse events



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Ages Eligible for Study:   12 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02443805


Locations
United States, Florida
University of South of Florida
Tampa, Florida, United States, 33610
France
CHU Arnaud de Villeneuve
Montpellier, France, 34295
Sponsors and Collaborators
Stallergenes Greer
Investigators
Principal Investigator: Pascal Demoly, MD CHU Arnaud de Villeneuve, Montpellier, France
Principal Investigator: Tom Casale, MD University of South of Florida, Tampa, USA

Responsible Party: Stallergenes Greer
ClinicalTrials.gov Identifier: NCT02443805     History of Changes
Other Study ID Numbers: SL75.14
First Posted: May 14, 2015    Key Record Dates
Last Update Posted: September 11, 2018
Last Verified: September 2018

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic
Rhinitis, Allergic, Perennial
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases