An Exploratory Study of PQ Grass 27600 SU

NCT04687059 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: PQGrass3092020-000408-13
• Study Type: interventional
• Target: 119
• Locations: 2 countries
• Sites: 14

Brief Summary

PQGrass309 is aimed at exploring the expected average treatment effect of PQ Grass 27600 SU cumulative dose on symptom and medication score in a field setting. The study will enrol adult subjects with seasonal allergic rhinitis and/or rhinoconjunctivitis (SAR) induced by grass pollen exposure.

Conditions

Rhinitis, Allergic, Seasonal

Keywords

PQ Grass; Seasonal Allergic Rhinitis or Rhinoconjunctivitis

Outcome Measures

Primary Outcomes (1)

• CSMS (Combined Symptom and Medication Score) Averaged Over the Peak Grass Pollen Season (GPS)

  The daily CSMS is calculated as the sum of the daily Symptom Score (dSS) and the daily Medication Score (dMS). The dSS component of the CSMS is calculated as the sum of 6 individual symptom (2 conjunctival and 4 nasal) scores, each with a range of 0 to 3 points and divided by 6, and therefore has a total range between 0 and 3. The dMS is a score assigned according to the step of relief medication used in a day (from 0: no relief medication to 3: oral corticosteroids with step and step 2 medications). The daily CSMS has a range between 0 and 6. The average CSMS over the peak GPS will be calculated as sum of the daily CSMS within the peak GPS divided by the number of days of the peak GPS where the CSMS has been collected. Higher values in the scale represent worse outcomes.

  Measures collected approximately over 2-5 weeks (peak GPS). The exact time frame depended on the GPS start and end dates for each region (depending on pollen detection), therefore, a specific week from baseline can not be estimated globally.

Secondary Outcomes (24)

• CSMS Averaged Over the Entire (or Truncated) GPS

  Measures collected approximately over 10 weeks (entire/truncated GPS). The exact time frame depended on the GPS start and end dates for each region (depending on pollen detection), therefore, a specific week from baseline can not be estimated globally.

• Total Combined Score (TCS) Averaged Over the Peak GPS

  Measures collected approximately over 2-5 weeks (peak GPS). The exact time frame depended on the GPS start and end dates for each region (depending on pollen detection), therefore, a specific week from baseline can not be estimated globally.

• TCS Averaged Over Entire (or Truncated) GPS

  Measures collected approximately over 10 weeks (entire/truncated GPS). The exact time frame depended on the GPS start and end dates for each region (depending on pollen detection), therefore, a specific week from baseline can not be estimated globally.

• Daily Symptom Score (dSS) of the CSMS Averaged Over the Peak and Entire (or Truncated) GPS

  Measures collected approximately over 2-5 weeks (peak GPS) or 10 weeks (entire/truncated GPS). The exact time frame depended on the GPS start and end dates for each region (depending on pollen detection).

• Daily Medication Score (dMS) of the CSMS Averaged Over the Peak and Entire (or Truncated) GPS

  Measures collected approximately over 2-5 weeks (peak GPS) or 10 weeks (entire/truncated GPS). The exact time frame depended on the GPS start and end dates for each region (depending on pollen detection).

Study Arms (4)

PQ Grass Conventional Dosing Regimen

EXPERIMENTAL

Cumulative dose 27600 SU

Biological: PQ Grass

PQ Grass Extended Dosing Regimen

EXPERIMENTAL

Cumulative dose 27600 SU

Biological: PQ Grass

Active Placebo

PLACEBO COMPARATOR

Suspension for injection

Drug: Active Placebo

Standard Placebo

PLACEBO COMPARATOR

Solution for injection

Drug: Standard Placebo

Interventions

PQ Grass BIOLOGICAL

Suspension for injection

PQ Grass Conventional Dosing Regimen; PQ Grass Extended Dosing Regimen

Active Placebo DRUG

Suspension for injection

Also known as: Placebo containing MCT

Active Placebo

Standard Placebo DRUG

Solution for injection

Also known as: Placebo without MCT

Standard Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Informed Consent
• Capable of giving signed informed consent and demonstrates willingness to comply with the requirements and restrictions listed in the ICF and study protocol and to attend required study visits.
• Subject who has signed and dated the ICF.
• \- Age:
• to 65 years of age inclusive, at the time of signing the ICF.
• \- Sex / Contraceptive requirements:
• 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) or females of childbearing potential who agree to comply with the contraceptive requirements of the study protocol.
• \- Subjects and general health characteristics:
• Good general health, as determined by the investigator, based on a medical evaluation, including medical history, physical examination, 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 study procedures.
• Positive history of moderate to severe symptoms of seasonal allergic rhinitis and/or rhinoconjunctivitis ascribed to grass (Pooideae) pollen exposure that required repeated use of antihistamines, nasal corticosteroids, and/or leukotriene modifiers for relief of symptoms during the last 2 consecutive seasons prior to the study, 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 \[GINA, 2020\]).
• A positive SPT for grass pollen (wheals \[longest diameter\] ≥3 mm and histamine ≥3 mm) and a negative SPT to the negative control (wheal diameter =0) at screening.
• Grass specific IgE class ≥2 as documented by an ImmunoCAP test at screening.
• FEV1 ≥80% of predicted, with a FEV1/FVC ratio ≥70% and (PEFR) ≥75% predicted at screening.

You may not qualify if:

• \- Medical conditions:
• Pregnant or lactating subject.
• Moderate to severe allergy symptoms during the screening and treatment periods, and/or GPS caused by perennial allergens or seasonal allergens (other than grass) as verified by medical history and positive SPT.
• Exception: screening, treatment and collection of eDiary data can 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 a positive SPT at US and EU sites in regions with relevant southern grass (Bahia grass, Bermuda grass or Johnson grass) exposure.
• Moderate to severe symptoms during the 3 years prior to Visit 1 to another seasonal or perennial allergen not tested in the SPT that cannot be avoided during the study and the symptoms of which may interfere with administration of treatment and /or impact the data collected, as determined by the investigator.
• Presence of any medical condition that may reduce the ability to survive a serious allergic reaction.
• History of autoimmune disease including Hashimoto's thyroiditis or other immunological disorder or other diseases (including, but not limited to, malignancy, cardiovascular, gastro-intestinal, hepatic, renal, hematological, 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 study treatment.
• Presence of severe or uncontrolled or partly controlled asthma as defined in the GINA guidelines (GINA 2020) or asthma that requires more than a daily dose above 400 mcg of inhaled budesonide or equivalent.
• Emergency room visit or hospitalisation for asthma in the 12 months prior to screening and randomisation or any history of a life-threatening asthma attack.
• Presence of 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, which could interfere with the evaluation of CPT.
• Eye surgery within the past 6 months.
• Presence of any skin conditions (e.g. skin abnormalities, tattoos) which might interfere with the interpretation of the SPT results.

Sponsors & Collaborators

• Allergy Therapeutics: lead

Study Sites (14)

Allergy and Asthma Associates of Bluegrass

Lexington, Kentucky, 40509, United States

Location

Chesapeake Clinical Research, Inc.

White Marsh, Maryland, 21236, United States

Location

Atlantic Research Center, LLC

Ocean Township, New Jersey, 07712, United States

Location

Smith Allergy & Asthma Specialists

Cortland, New York, 13045, United States

Location

Corning Center for Clinical Research

Horseheads, New York, 14845, United States

Location

Allergy Partners of Western North Carolina

Asheville, North Carolina, 28801, United States

Location

Bernstein Clinical Research Center, LLC

Cincinnati, Ohio, 45231, United States

Location

Allergy Asthma & Sinus Center, S.C.

Greenfield, Wisconsin, 53228, United States

Location

Universitatsmedizin Berlin - Charite Campus Mitte - Allergie Centrum Charite

Berlin, Germany

Location

Universitätsklinikum Carl Gustav Carus an der TU Dresden

Dresden, Germany

Location

ENT RESEARCH - Institut für klinische Studien

Essen, Germany

Location

Medaimun GmbH

Frankfurt am Main, Germany

Location

Hamburger Institut für Therapieforschung GmbH

Hamburg, Germany

Location

Studienzentrum Dr. Sabine Laßmann

Saalfeld, Germany

Location

Related Publications (1)

• Layhadi JA, Starchenka S, De Kam PJ, Palmer E, Wu LYD, Keane ST, Fulton WT, Hikmawati P, Meng X, Filipaviciute P, Cutrina Pons A, Oluwayi K, Lis K, Armfield O, Skinner MA, Heath MD, Hewings SJ, Kramer MF, Shamji MH. Modulation of Cellular, Molecular, and Humoral Responses by PQ Grass 27,600 SU for the Treatment of Seasonal Allergic Rhinitis: A Randomised Double Blind Placebo Control Exploratory Field Study. Allergy. 2026 Jan;81(1):232-247. doi: 10.1111/all.16640. Epub 2025 Jul 8.

  PMID: 40626378 DERIVED

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal

Condition Hierarchy (Ancestors)

Rhinitis, Allergic; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Pieter-Jan De Kam, Clinical Director
• Organization: Allergy Therapeutics (UK) Ltd.

pieter-jan.dekam@allergytherapeutics.com

+44 (0) 1903 844 700

Study Officials

• Pieter-Jan de Kam, Ph.D

  Global R&D - Clinical Director

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2020
• First Posted: December 29, 2020
• Study Start: October 19, 2020
• Primary Completion: August 18, 2021
• Study Completion: October 28, 2021
• Last Updated: April 29, 2026
• Results First Posted: April 29, 2026

Record last verified: 2026-04

Locations

DE (6); US (8)