Six Injections of Modified Adjuvanted PQ Grass Is Effective and Well‐Tolerated in a Pivotal Phase III Trial
Year: 2025
Type: article
Study designs: Randomized Controlled Trial, Clinical Trial
Abstract: ABSTRACT Background PQ Grass 27600 SU (PQ Grass) cumulative dose is a pre‐seasonal, six‐injection, aluminium‐free, modified subcutaneous immunotherapy product under development for the treatment of allergic rhinitis (AR). A pivotal Phase III randomised double‐blind, placebo‐controlled clinical trial was performed to evaluate the efficacy and safety of PQ Grass in subjects with seasonal AR. Methods An adaptive group sequential trial PQGrass306 (G306) with one pre‐defined interim analysis was designed, using 2 parallel groups applying a 1:1 active versus placebo randomisation of patients aged 18–65. The primary efficacy endpoint was the EAACI (European Academy of Allergy and Clinical Immunology) Combined Symptom and Medication Score (EAACI‐CSMS 0–6 ) averaged over the peak grass pollen season (GPS). Results 858 subjects were screened and 555 subjects were randomised. Based on the results of the pre‐defined interim analysis, the trial was stopped for success showing superiority in favour of PQ Grass. The primary endpoint EAACI‐CSMS 0–6 (peak GPS) demonstrated a highly significant and clinically meaningful point difference of PQ Grass over placebo of −0.27 points (95% CI: −0.42 to −0.12), corresponding to a relative difference of −20.3% ( p = 0.0005). Highly consistent and beneficial results were obtained for PQ Grass for all key secondary endpoints. Significant induction of blocking IgG4 and IgA antibody subclasses occurred. PQ Grass was well tolerated, and no unexpected safety signals occurred. Conclusions This pivotal Phase III trial demonstrated a significant and clinically meaningful effect on the primary endpoint as well as highly consistent secondary endpoint results and a supportive safety profile.
Source: Allergy
DOI: 10.1111/all.16491
Authors: Stefan Zielen, Jonathan A. Bernstein, Gunter J. Sturm, Marek Jutel, Oliver Pfaar, the RESONATE Investigator Group, Mohamed H. Shamji, Ralph Mösges, Markus Berger, Uwe E. Berger, Lawrence DuBuske, Janice A. Layhadi, Ludger Klimek, Markus Ollert, Murray A. Skinner, Matthias F. Kramer, Pieter‐Jan de Kam
Institutions: Goethe University Frankfurt, University Hospital Frankfurt, Bernstein Clinical Research Center, University of Cincinnati, Medical University of Graz, Wroclaw Medical University, All-Med, Philipps University of Marburg, NIHR Imperial Biomedical Research Centre, Imperial College London, University of Cologne, Sigmund Freud Privatuniversität Wien, Wiener Krankenanstaltenverbund, Allergiezentrum Wien West, Universität Innsbruck, George Washington University Hospital, Zentrum für Rhinologie und Allergologie, Odense University Hospital, Luxembourg Institute of Health, Allergy Therapeutics (United Kingdom)
Language: English
Subfield: Immunology and Allergy
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $5,300
Funder: Allergy Therapeutics
OpenAlex ID: W4407183565