Efficacy and Safety of PQ Grass in Subjects With Seasonal Allergic Rhinitis and/or Rhinoconjunctivitis Induced by Grass Pollen

Summary

The PQGrass306 (G306) clinical trial is the pivotal Phase III efficacy clinical trial of PQ Grass. The aim of the G306 pivotal clinical trial is to confirm the efficacy and safety of the optimal effective dose of PQ Grass 27600 SU. This will be determined through the measurements of the effect of PQ Grass on the symptoms of seasonal allergic rhinitis (SAR)/rhinoconjunctivitis and the use of relief medications to control these symptoms during the peak grass pollen season (GPS).

Timeline

Start

2022-10-11

Primary completion

2023-11-01

Completion

2023-11-01

Outcome

Met primary endpoint

registry analysis (superiority test); PQ Grass vs Placebo; p = 0.00048; relative difference (%) -20.25 (95% CI -31.0 to -9.49); Mixed Models Analysis NCT05540717 ↗

Publications

• Layhadi JA, Starchenka S, De Kam PJ, Palmer E, Wu LYD, Keane ST, Fulton WT, Hikmawati P, Meng X, Filipaviciute P, Cutrina Pons A, Oluwayi K, Lis K, Armfield O, Skinner MA, Heath MD, Hewings SJ, Kramer MF, Shamji MH. Modulation of Cellular, Molecular, and Humoral Responses by PQ Grass 27,600 SU for the Treatment of Seasonal Allergic Rhinitis: A Randomised Double Blind Placebo Control Exploratory Field Study. Allergy. 2026 Jan;81(1):232-247. doi: 10.1111/all.16640. Epub 2025 Jul 8.

Drugs

Indications