Phase 3 N=1,607 Randomized Quadruple-blind Treatment

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

Bottom Line

View on ClinicalTrials.gov: NCT02443805 ↗

Enrolled (actual)

1,607

Serious AEs

1.9%

Results posted

Sep 2019

Primary outcome: Primary: Total Combined Score — 3.62; 4.35 Units on a scale — p=<0.0001

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: 300 IR (Biological); Placebo (Biological)
Age: Pediatric, Adult, Older Adult · 12+ yrs
Sex: All
Sponsor: Stallergenes Greer
Primary completion: Jun 2018

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	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02443805). 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.