Phase 3
Completed N=1,607
Efficacy & Safety of STG320 Sublingual Tablets of HDM Allergen Extracts in Adults and Adolescents With HDM-associated AR
Rhinitis, Allergic, Perennial · House dust mite allergy
Source: ClinicalTrials.gov NCT02443805 ↗
Enrolled (actual)
1,607
Serious AEs
1.9%
Results posted
Sep 2019
Primary outcomePrimary: Total Combined Score — 3.62; 4.35 Units on a scale — p=<0.0001
◆ Published Evidence
Emerging
5citations · ~3 / year
Safety of 300IR house dust mite sublingual tablet from pooled clinical trial and post-marketing data.
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.
Linked Publications (2)
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Safety of 300IR house dust mite sublingual tablet from pooled clinical trial and post-marketing data.
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Clinical benefits with 300 IR HDM SLIT tablet in Europeans with house dust mite allergic rhinitis: Post hoc analysis of a large phase 3 trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Combined Score |
3.62; 4.35 | <0.0001 sig |
| SECONDARY Average Rhinitis Total Symptom Score (RTSS) |
3.16; 3.79 | — |
| SECONDARY Average Rescue Medication Score (RMS) |
0.21; 0.30 | — |
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
Data sourced from ClinicalTrials.gov (NCT02443805) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.