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NCT02443805 · ClinicalTrials.gov registry record · Phase 3
Efficacy & Safety of STG320 Sublingual Tablets of HDM Allergen Extracts in Adults and Adolescents With HDM-associated AR
A Phase 3 study of Rhinitis, Allergic, Perennial and House Dust Mite Allergy, sponsored by Stallergenes Greer.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,607
- Enrollment target
- 2
- Study locations
NCT02443805: Completed Phase 3 study of Rhinitis, Allergic, Perennial and House Dust Mite Allergy, sponsored by Stallergenes Greer.
NCT02443805 is a Phase 3 study of Rhinitis, Allergic, Perennial and House Dust Mite Allergy that has completed, run by Stallergenes Greer. The registered enrollment target is 1,607 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (108% higher). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02443805, a Phase 3 study of Rhinitis, Allergic, Perennial and House Dust Mite Allergy, has completed, sponsored by Stallergenes Greer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,607 participants
- Enrollment target
- 2
- Study locations
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL 300 IR
Study Locations (2)
Florida
- University of South of Florida - Tampa
Other
- CHU Arnaud de Villeneuve - Montpellier
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,607 participants |
| Start Date | 2015-09-29 |
| Est. Completion | 2018-06-25 |
| Phase | Phase 3 |
What the finished NCT02443805 record still lists
NCT02443805 is an interventional study that assigns participants to a tested intervention. Its 1,607 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (108% higher).
The record links to 2 conditions, with Rhinitis, Allergic, Perennial appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT02443805 reports a single indexed study location in Florida, Other.
Frequently Asked Questions
What is clinical trial NCT02443805 about?
NCT02443805 is a clinical study titled "Efficacy & Safety of STG320 Sublingual Tablets of HDM Allergen Extracts in Adults and Adolescents With HDM-associated AR". 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.
What is the current status of trial NCT02443805?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,607 participants. The study started on 2015-09-29. Estimated completion is 2018-06-25.
What conditions does trial NCT02443805 study?
This clinical trial studies the following conditions: Rhinitis, Allergic, Perennial, House Dust Mite Allergy.
What interventions are being tested in trial NCT02443805?
The interventions under investigation include: Placebo (BIOLOGICAL), 300 IR (BIOLOGICAL).
Who is sponsoring clinical trial NCT02443805?
This trial is sponsored by Stallergenes Greer, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02443805 being conducted?
This trial has 2 study locations across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02443805's enrollment target sits among peer trials
1,607 142nd of 2000 higher than 1,859 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
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Source ClinicalTrials.gov registry export · 2026-08-08
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