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Efficacy and Safety of PQ Grass in Subjects With Seasonal Allergic Rhinitis and/or Rhinoconjunctivitis Induced by Grass Pollen | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

NCT05540717•Allergy Therapeutics

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Capable of giving signed informed consent as described in Appendix 1 which includes compliance with the requirements and restrictions listed in the ICF (informed consent form) and in this clinical trial protocol and to attend required clinical trial visits.
•2. Subject who has a signed and dated ICF.
•3. Subject must be 18 to 65 years of age inclusive, at the time of signing the ICF.
•4. Male or female.
•5. Female subjects who are not of childbearing potential (defined as at least 12 months natural spontaneous amenorrhoea, or at least 6 weeks following surgical menopause/permanent sterilisation \[hysterectomy, bilateral oophorectomy and bilateral salpingectomy\]) or females of childbearing potential who agree to comply with the contraceptive requirements of the clinical trial protocol.
•6. Good general health, as determined by the Investigator, based on a medical evaluation, including medical history, physical examination, mental status assessment and laboratory tests. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator agrees that the finding is unlikely to introduce additional risk factors and will not interfere with the clinical trial procedures.
•7. Positive history of moderate to severe symptoms of SAR/rhinoconjunctivitis ascribed to grass (Pooideae) pollen exposure of at least 2 seasons duration, despite having received allergy pharmacotherapy (e.g., antihistamines, nasal corticosteroids, leukotriene modifiers, etc.) during the last 2 consecutive grass pollen seasons prior to the clinical trial, confirmed by subject records.
•Please note: Subjects with asthma may be included, but the asthma must be well controlled (according to current Global Initiative for Asthma \[GINA\] guidelines \[GINA 2022\]).
•8. A positive SPT (skin prick test) to histamine (wheals \[longest diameter\] ≥3 mm) and a negative SPT to the negative control (wheal diameter = 0 mm) at screening.
•9. A positive SPT for grass pollen (wheals \[longest diameter\] ≥3 mm).
+2 more criteria

Exclusion Criteria

•1. Pregnant or lactating subject.
•2. Presence of any medical history of moderate to severe allergy symptoms (verified by a positive SPT at screening or positive specific IgE \[≥2\] at screening) to any other seasonal allergen (other than grass) or perennial allergens.
•Exception: Period 1, Period 2 and Period 3 of the entire clinical trial will be conducted outside of the pollen season(s) of concern or perennial allergies are irrelevant due to avoidance measures (e.g., cats and dog allergy). Subjects with mild allergy symptoms (only) to any other allergen apart from grass may be included at the discretion of the Investigator. In countries in Europe where Bermuda grass is present, any medical history of moderate to severe allergy symptoms to Bermuda grass (verified by a positive SPT or positive specific IgE \[Class ≥2\]), will also represent a reason for exclusion as it will not be possible to conduct Period 1, Period 2 and Period 3 of the entire clinical trial outside of Bermuda grass pollen season. Albeit Bermuda grass being commonly defined as a grass, it belongs to the Poaceae family, while the sentence (other than grass) in Exclusion criterion #2 refers to grass of Pooideae subfamily (as defined in Inclusion criterion #7).
•3. Subjects at US clinical trial sites in regions where southern grasses (Bahia grass, Bermuda grass or Johnson grass) are the dominant grasses and the main cause of grass allergy symptoms with a positive SPT to any of the 3 grasses (irrespective of the severity of symptoms).
•4. Moderate to severe symptoms during the 3 years prior to Visit 1 to any other seasonal or perennial allergen not tested in the SPT done at screening that cannot be avoided during the Period 1 to Period 3 of the clinical trial and the symptoms of which may interfere with administration of treatment and/or impact the data collected.
•5. Presence of any medical condition that may reduce the ability to survive a serious allergic reaction.
•6. Presence of active systemic autoimmune disorder, systemic autoimmune disorders in remission or active organ specific autoimmune disorder.
•7. Presence of active malignant neoplasia, severe cardiovascular disease (e.g., coronary artery disease, cardiac insufficiency, etc.), pulmonary insufficiency, severe psychiatric disorders or primary and secondary immunodeficiencies.
•8. History of any other immunological disorder or other diseases (including, but not limited cardiovascular \[including uncontrolled or inadequately controlled hypertension\], gastro-intestinal, hepatic, renal, haematological, neurological, endocrine or pulmonary disease) that in the opinion of the Investigator may pose a safety risk or compromise the interpretation of efficacy of the clinical trial treatment.
•9. Presence of severe or poorly controlled or uncontrolled asthma as defined by at least 1 of the following criteria:
+45 more criteria

Locations (102)

IMMUNOe Research Centers

Centennial, Colorado, United States

Velocity Clinical Research Denver

Denver, Colorado, United States

Allergy Partners of Central Kentucky

Lexington, Kentucky, United States

Allergy and Asthma Associates of Bluegrass

Lexington, Kentucky, United States

Family Allergy Asthma Research Institute

Louisville, Kentucky, United States

Allergy & Asthma Specialists PSC

Owensboro, Kentucky, United States

Northern Light Allergy and Immunology

Bangor, Maine, United States

Paul A. Shapero M.D.

Bangor, Maine, United States

Chesapeake Clinical Research Inc

White Marsh, Maryland, United States

Respiratory Medicine Research Institute of Michigan

Ypsilanti, Michigan, United States

Key Dates

Start Date

October 11, 2022

Primary Completion Date

November 1, 2023

Completion Date

November 1, 2023

Last Updated

April 2, 2025

Enrollment

555

ACTUAL participants

Conditions

Seasonal Allergic RhinitisRhinoconjunctivitis

Interventions

PQ Grass

BIOLOGICAL

Placebo

BIOLOGICAL

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RECRUITINGPHASE4

Evaluation of the Efficacy of Allergen-specific Immunotherapy Using Assessment in an Allergen Exposure chamber-a Randomized Placebo-controlled Double-blind Study

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 2, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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