NCT05540717

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

A Randomised, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Efficacy and Safety of PQ Grass in Subjects With Seasonal Allergic Rhinitis and/or Rhinoconjunctivitis Induced by Grass Pollen Exposure

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 555 (actual)
• Sponsor: Allergy Therapeutics · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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).

Detailed description

Multi-centre, randomised, parallel group, double-blind, placebo-controlled clinical trial to confirm the efficacy and safety of the optimal effective dose of PQ Grass (27600 SU). Randomized study subjects, in a randomisation ratio of 1:1, will receive either treatment with 6 injections of active treatment (900, 2700, 6000, 6000, 6000 and 6000 SU sequentially) to achieve a cumulative nominal dose of 27600 SU, or 6 injections of placebo prior to the onset of the grass pollen season (GPS). The aim of the study is to confirm the efficacy and safety of the optimal effective dose of the PQ Grass 27600 SU dose. Efficacy 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 GPS.

Conditions

• Seasonal Allergic Rhinitis
• Rhinoconjunctivitis

Interventions

Type	Name	Description
BIOLOGICAL	PQ Grass	Suspension for Injection
BIOLOGICAL	Placebo	Solution for injection

Timeline

• Start date: 2022-10-11
• Primary completion: 2023-11-01
• Completion: 2023-11-01
• First posted: 2022-09-15
• Last updated: 2025-04-02
• Results posted: 2025-04-02

Locations

102 sites across 6 countries: United States, Austria, Czechia, Germany, Hungary, Poland

Regulatory

• FDA-regulated drug study