Evidence map›Paper›PMID 39905623›Full record

Trial reportAllergy2025

Six Injections of Modified Adjuvanted PQ Grass Is Effective and Well-Tolerated in a Pivotal Phase III Trial.

Stefan Zielen, Jonathan A Bernstein, Gunter J Sturm, Marek Jutel, Oliver Pfaar, RESONATE Investigator Group, Mohamed H Shamji, Ralph Mösges, Markus Berger, Uwe E Berger and 7 more

Abstract readClinical Trial, Phase IIIRandomized Controlled TrialMulticenter Study
In one paragraph

Trial report in Allergy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

6 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
  4. Article
  5. Article
  6. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

17 authors.

Stefan ZielenDepartment of Pediatrics, University Hospital, Goethe University, Frankfurt, Germany.ORCID https://orcid.org/0000-0003-1204-0627
Jonathan A BernsteinDivision of Rheumatology, Allergy and Immunology, University of Cincinnati College of Medicine, Cincinnati, Ohio, USA.ORCID https://orcid.org/0000-0002-3476-1196
Gunter J SturmDepartment of Dermatology and Venereology, Medical University of Graz, Graz, Austria.ORCID https://orcid.org/0000-0002-7245-121X
Marek JutelDepartment of Clinical Immunology, Faculty of Medicine, Wrocław Medical University, Wrocław, Poland.ORCID https://orcid.org/0000-0003-1555-9379
Oliver PfaarSection of Rhinology and Allergy, Department of Otorhinolaryngology, Head and Neck Surgery, University Hospital Marburg, Philipps-Universität Marburg, Marburg, Germany.ORCID https://orcid.org/0000-0003-4374-9639
RESONATE Investigator Group
Mohamed H ShamjiNational Heart and Lung Institute, Imperial College London, London, UK.ORCID https://orcid.org/0000-0003-3425-3463
Ralph MösgesIMSB, Medical Faculty University at Cologne, Cologne, Germany.ORCID https://orcid.org/0000-0002-1928-810X
Markus BergerDepartment of Oto-Rhino-Laryngology, Head and Neck Surgery, Klinik Landstraße, Wiener Gesundheitsverbund, Vienna, Austria.ORCID https://orcid.org/0000-0001-8297-4412
Uwe E BergerDepartment of Botany, University of Innsbruck, Innsbruck, Austria.ORCID https://orcid.org/0000-0002-9265-2131
Lawrence DuBuskeGeorge Washington University Hospital, Washington, DC, USA.ORCID https://orcid.org/0000-0001-5013-8022
Janice A LayhadiNational Heart and Lung Institute, Imperial College London, London, UK.ORCID https://orcid.org/0000-0002-5242-1806
Ludger KlimekCenter for Rhinology and Allergy, Wiesbaden, Germany.ORCID https://orcid.org/0000-0002-2455-0192
Markus OllertDepartment of Infection and Immunity, Luxembourg Institute of Health, Esch-sur-Alzette, Luxembourg.ORCID https://orcid.org/0000-0002-8055-0103
Murray A SkinnerAllergy Therapeutics (UK) Plc, Worthing, UK.ORCID https://orcid.org/0009-0008-4935-4316
Matthias F KramerAllergy Therapeutics (UK) Plc, Worthing, UK.ORCID https://orcid.org/0000-0002-3740-4733
Pieter-Jan de KamAllergy Therapeutics (UK) Plc, Worthing, UK.ORCID https://orcid.org/0000-0003-0859-4862

Funding

Allergy Therapeutics
6 · The paper itself

Abstract

backgroundPQ 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.

methodsAn 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

results858 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

conclusionsThis 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.

Indexed as

Adjuvants, ImmunologicAllergensDesensitization, ImmunologicPoaceaeRhinitis, Allergic, SeasonalAdolescentAdultAgedDouble-Blind MethodFemaleHumansImmunoglobulin EMaleMiddle AgedTreatment OutcomeYoung AdultAdjuvants, ImmunologicAllergensImmunoglobulin Eallergic rhinoconjunctivitisgrass pollen allergypivotal Phase III clinical trialshort‐course treatmentsubcutaneous immunotherapy

Identifiers

PMID39905623
PMCPMC12261879

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.