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

Completed · Phase 3 · Has a placebo group

Conditions studied: Seasonal Allergic Rhinitis, Rhinoconjunctivitis

In brief

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).

Key facts

Study ID: NCT05540717
Run by: Allergy Therapeutics
People needed: 555
Starts: 2022-10-11
Expected to finish: 2023-11-01
Last updated by the study team: 2025-04-02

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.
Subject who has a signed and dated ICF.
Subject must be 18 to 65 years of age inclusive, at the time of signing the ICF.
Male or female.
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.
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.
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]).
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.
A positive SPT for grass pollen (wheals [longest diameter] ≥3 mm).
Grass specific IgE (immunoglobulin E) class ≥2 as documented by an ImmunoCAP test at screening.
Forced expiratory volume in one second (FEV1) ≥70% of predicted, with a FEV1/forced vital capacity (FVC) ratio >75% and PEFR (peak expiratory flow rate) ≥70% of predicted at screening.

You may not qualify if…

Pregnant or lactating subject.
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).
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).
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.
Presence of any medical condition that may reduce the ability to survive a serious allergic reaction.
Presence of active systemic autoimmune disorder, systemic autoimmune disorders in remission or active organ specific autoimmune disorder.
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.
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.
Presence of severe or poorly controlled or uncontrolled asthma as defined by at least 1 of the following criteria:
Severe asthma (as per the current GINA guidelines [GINA, 2022]).
Uncontrolled or poorly controlled asthma as per the current GINA guidelines (GINA, 2022).
Asthma that requires more than a daily dose above 800 μg of inhaled budesonide (or clinically comparable inhaled corticosteroid) as per the current GINA guidelines (GINA, 2022).
History of 2 or more systemic corticosteroid courses within 6 months of screening or Visit 2 or 1 course of systemic corticosteroids within 3 months of screening or Visit 2 to treat asthma.
Prior intubation/mechanical ventilation for asthma.
Emergency room visit or hospitalisation for asthma in the 12 months prior to screening or Visit 2.
Any history of a life-threatening asthma attack.
FEV1 <70% of predicted or FEV1/FVC ≤75% or PEFR <70% of predicted with or without controller medications at screening or Visit 2.
Presence non-atopic rhinitis and/or rhino-sinusitis (with or without polyps).
Presence of nasal polyps and/or chronic sinusitis.
Presence of any acute or chronic ocular disorder, other than allergic conjunctivitis.
Eye surgery within the past 6 months.
Presence of any skin conditions (e.g., skin abnormalities, tattoos etc.), which might interfere with the interpretation of the SPT results.
Clinical history of Type I diabetes or poorly controlled Type II diabetes.
Moderate to severe upper or lower respiratory infections requiring medication within 14 days before screening (Visit 1) or Visit 2.

Where it is running

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
Clinical Research of The Ozarks Inc - Warrensburg — Columbia, Missouri, United States
Montana Medical Research — Missoula, Montana, United States
Nebraska Medical Research Institute, The Asthma & Allergy Center — Bellevue, Nebraska, United States
Parikh Institute for Research LLC — Highland Park, New Jersey, United States
Atlantic Research Center LLC — Ocean City, New Jersey, United States
Weiss Medical — Riverdale, New Jersey, United States
Allergy Asthma and Immunology Research Institute — Charlotte, North Carolina, United States
Cincinnati Allergy and Asthma Center — Cincinnati, Ohio, United States
Bernstein Clinical Research Center, LLC — Cincinnati, Ohio, United States
Optimed Research Ltd — Columbus, Ohio, United States
Toledo Institute of Clinical Research Inc — Toledo, Ohio, United States
Oklahoma Institute of Allergy and Asthma Clinical Research, LLC - CRN - PPDS — Oklahoma City, Oklahoma, United States
Velocity Clinical Research, Inc — Grants Pass, Oregon, United States
Velocity Clinical Research - Medford - ERN - PPDS — Medford, Oregon, United States
Northwest Research Center — Portland, Oregon, United States
IMMUNOe Research Centers — Centennial, Colorado, United States

Full record on ClinicalTrials.gov

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