drugset / Trial / NCT04687059

An Exploratory Study of PQ Grass 27600 SU

NCT04687059 ↗

Phase 2/3 Completed 119 enrolled Allergy Therapeutics
RandomizedParallel-groupQuadruple-blindTreatment

Summary

PQGrass309 is aimed at exploring the expected average treatment effect of PQ Grass 27600 SU cumulative dose on symptom and medication score in a field setting. The study will enrol adult subjects with seasonal allergic rhinitis and/or rhinoconjunctivitis (SAR) induced by grass pollen exposure.

Timeline

Start
2020-10-19
Primary completion
2021-08-18
Completion
2021-10-28

Outcome

Met primary endpoint

registry analysis (superiority test); PQ Grass Conventional Dosing Regimen vs Placebo (Containing MCT); p = 0.0325; Median Difference (Final Values) -33.1 (80% CI -48.8 to -17.4) NCT04687059 ↗

registry analysis (superiority test); PQ Grass Extended Dosing Regimen vs Placebo (Containing MCT); p = 0.0112; Mean Difference (Final Values) -39.5 (80% CI -54.7 to -24.4) NCT04687059 ↗

release “Primary endpoint was met with a highly statistically significant dose-response relationship” allergytherapeutics.com ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject PQ Grass Unknown 27600 unknown Subcutaneous