Back to resultsEfficacy & Safety of STG320 Sublingual Tablets of HDM Allergen Extracts in Adults and Adolescents With HDM-associated AR
Primary Purpose
Rhinitis, Allergic, Perennial, House Dust Mite Allergy
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
300 IR
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Rhinitis, Allergic, Perennial
Eligibility 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
Sites / Locations
- University of South of Florida
- CHU Arnaud de Villeneuve
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
300 IR
Placebo
Arm Description
300 IR tablet of HDM Allergen Extracts
Placebo tablet
Outcomes
Primary Outcome Measures
Total Combined Score
Average Total Combined Score (TCS), calculated for each patient as the average of the non-missing daily TCSs during the primary evaluation period. The daily TCS (scale 0-15) was the sum of the patient's daily Rhinitis Total Symptom Score (RTSS, scale 0-12) and daily Rescue Medication Score (RMS, scale 0-3). Lower is better.
Secondary Outcome Measures
Average Rhinitis Total Symptom Score (RTSS)
Average RTSS during the primary evaluation period. The daily Total Symptom Scores (RTSS) was the sum of the 4 rhinitis symptom scores: sneezing, rhinorrhoea, nasal pruritus and nasal congestion, each graded on a 4-point scale (0-3; 0: absent, 1: mild, 2: moderate, 3: severe).
It ranges from 0 to 12. Lower is better.
Average Rescue Medication Score (RMS)
Average RMS during the primary evaluation period. Rescue Medication Score (RMS) ; range 0-3, lower is better.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02443805
Brief Title
Efficacy & Safety of STG320 Sublingual Tablets of HDM Allergen Extracts in Adults and Adolescents With HDM-associated AR
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
September 29, 2015 (Actual)
Primary Completion Date
June 25, 2018 (Actual)
Study Completion Date
June 25, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stallergenes Greer
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rhinitis, Allergic, Perennial, House Dust Mite Allergy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1607 (Actual)
8. Arms, Groups, and Interventions
Arm Title
300 IR
Arm Type
Active Comparator
Arm Description
300 IR tablet of HDM Allergen Extracts
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo tablet
Intervention Type
Biological
Intervention Name(s)
300 IR
Intervention Description
300 IR tablet of HDM Allergen Extracts
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Placebo tablet
Primary Outcome Measure Information:
Title
Total Combined Score
Description
Average Total Combined Score (TCS), calculated for each patient as the average of the non-missing daily TCSs during the primary evaluation period. The daily TCS (scale 0-15) was the sum of the patient's daily Rhinitis Total Symptom Score (RTSS, scale 0-12) and daily Rescue Medication Score (RMS, scale 0-3). Lower is better.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Average Rhinitis Total Symptom Score (RTSS)
Description
Average RTSS during the primary evaluation period. The daily Total Symptom Scores (RTSS) was the sum of the 4 rhinitis symptom scores: sneezing, rhinorrhoea, nasal pruritus and nasal congestion, each graded on a 4-point scale (0-3; 0: absent, 1: mild, 2: moderate, 3: severe).
It ranges from 0 to 12. Lower is better.
Time Frame
12 months
Title
Average Rescue Medication Score (RMS)
Description
Average RMS during the primary evaluation period. Rescue Medication Score (RMS) ; range 0-3, lower is better.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pascal Demoly, MD
Organizational Affiliation
CHU Arnaud de Villeneuve, Montpellier, France
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tom Casale, MD
Organizational Affiliation
University of South of Florida, Tampa, USA
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of South of Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33610
Country
United States
Facility Name
CHU Arnaud de Villeneuve
City
Montpellier
ZIP/Postal Code
34295
Country
France
12. IPD Sharing Statement
Learn more about this trial
Efficacy & Safety of STG320 Sublingual Tablets of HDM Allergen Extracts in Adults and Adolescents With HDM-associated AR
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