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

NCT05540717 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: PQGrass3062019-001517-16
• Study Type: interventional
• Target: 555
• Locations: 6 countries
• Sites: 102

Brief 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).

Conditions

Seasonal Allergic Rhinitis; Rhinoconjunctivitis

Outcome Measures

Primary Outcomes (1)

• Combined Symptom and Medication Score (CSMS) 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.

  dSS and dMS are recorded daily between Visit 8 (wk 16-29) and Visit 11 (wk 28-41). Then CSMS is adjusted to the Peak GPS, which depends on the GPS start and end dates for each region

Secondary Outcomes (22)

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

  dSS and dMS are recorded daily between Visit 8 (wk 16-29) and Visit 11 (wk 28-41). Then CSMS is adjusted to the entire GPS, which depends on the GPS start and end dates for each region

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

  dMS of the CSMS was recorded daily between Visit 8 (wk 16-29) and Visit 11 (wk 28-41). Then dMS is adjusted to the peak or entire GPS

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

  dSS of the CSMS was recorded daily between Visit 8 (wk 16-29) and Visit 11 (wk 28-41). Then dMS is adjusted to the peak or entire GPS

• Average Rhinoconjunctivitis Quality of Life Questionnaire With Standardized Activities (RQLQ(S)) Measured Within the Peak GPS

  RQLQ(s) is performed at Visit 2 (wk 2-8), Visit 9 (wk 18-31) and Visit 10 (wk 23-36).

• Change in Serum Grass-specific IgG4 (Immunoglobulin G4) From Baseline to Visit 7.

  Serum grass-specific IgG4 was measured at Visit 1 (baseline) and Visit 7 (wk 12-25)

Study Arms (2)

PQ Grass

EXPERIMENTAL

6 subcutaneous injections of active treatment (900, 2700, 6000, 6000, 6000 and 6000 SU sequentially) to achieve a cumulative nominal dose of 27600 SU

Biological: PQ Grass

Placebo

PLACEBO COMPARATOR

6 subcutaneous injections of placebo

Biological: Placebo

Interventions

PQ Grass BIOLOGICAL

Suspension for Injection

PQ Grass

Placebo BIOLOGICAL

Solution for injection

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:

• 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.
• 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.

Sponsors & Collaborators

• Allergy Therapeutics: lead

Study Sites (102)

IMMUNOe Research Centers

Centennial, Colorado, 80112, United States

Location

Velocity Clinical Research Denver

Denver, Colorado, 80209, United States

Location

Allergy Partners of Central Kentucky

Lexington, Kentucky, 40503, United States

Location

Allergy and Asthma Associates of Bluegrass

Lexington, Kentucky, 40509, United States

Location

Family Allergy Asthma Research Institute

Louisville, Kentucky, 40202, United States

Location

Allergy & Asthma Specialists PSC

Owensboro, Kentucky, 42301, United States

Location

Northern Light Allergy and Immunology

Bangor, Maine, 04401, United States

Location

Paul A. Shapero M.D.

Bangor, Maine, 04401, United States

Location

Chesapeake Clinical Research Inc

White Marsh, Maryland, 21162, United States

Location

Respiratory Medicine Research Institute of Michigan

Ypsilanti, Michigan, 48197, United States

Location

Clinical Research of The Ozarks Inc - Warrensburg

Columbia, Missouri, 65203, United States

Location

Montana Medical Research

Missoula, Montana, 59808, United States

Location

Nebraska Medical Research Institute, The Asthma & Allergy Center

Bellevue, Nebraska, 68123, United States

Location

Parikh Institute for Research LLC

Highland Park, New Jersey, 08904, United States

Location

Atlantic Research Center LLC

Ocean City, New Jersey, 07712, United States

Location

Weiss Medical

Riverdale, New Jersey, 07457, United States

Location

Allergy Asthma and Immunology Research Institute

Charlotte, North Carolina, 28204, United States

Location

Cincinnati Allergy and Asthma Center

Cincinnati, Ohio, 45209, United States

Location

Bernstein Clinical Research Center, LLC

Cincinnati, Ohio, 45236, United States

Location

Optimed Research Ltd

Columbus, Ohio, 43235, United States

Location

Toledo Institute of Clinical Research Inc

Toledo, Ohio, 43617, United States

Location

Oklahoma Institute of Allergy and Asthma Clinical Research, LLC - CRN - PPDS

Oklahoma City, Oklahoma, 73131, United States

Location

Velocity Clinical Research, Inc

Grants Pass, Oregon, 97527, United States

Location

Velocity Clinical Research - Medford - ERN - PPDS

Medford, Oregon, 97504, United States

Location

Northwest Research Center

Portland, Oregon, 97202, United States

Location

Allergy & Asthma Specialists

Blue Bell, Pennsylvania, 19422, United States

Location

Allergy and Clinical Immunology Associates

Pittsburgh, Pennsylvania, 15241, United States

Location

Allergy Associate of Utah

Murray, Utah, 84107, United States

Location

Lysosomal Rare Disorders Research & Treatment Center

Fairfax, Virginia, 22030-7404, United States

Location

Eastern Virginia Medical School

Norfolk, Virginia, 23507, United States

Location

Bellingham Asthma Allergy and Immunology Clinic

Bellingham, Washington, 98225, United States

Location

Allergy, Asthma & Sinus Center, S.C.

Greenfield, Wisconsin, 53228, United States

Location

University of Wisconsin Clinical Science Center

Madison, Wisconsin, 53792, United States

Location

Medizinische Universitaet Innsbruck - Universitatsklinik fuer Dermatologie, Venerologie und Allergologie

Innsbruck, 6020, Austria

Location

Bezirkskrankenhaus Kufstein

Kufstein, 6330, Austria

Location

Medizinische Universitat Wien (Medical University of Vienna)

Vienna, 1090, Austria

Location

Ambulatorium für Allergie und klinische Immunologie AAKI

Vienna, 1100, Austria

Location

Fakultní nemocnice u sv. Anny v Brně

Brno, 60200, Czechia

Location

MUDr. Jana Poloniová - alergologie a klinická imunologie

České Budějovice, 37001, Czechia

Location

Alergopraktik, s.r.o.

Jablonec nad Nisou, 46601, Czechia

Location

Alergologie a imunologie MUDr. Hofstetr

Jihlava, 58601, Czechia

Location

Alergoimuno s.r.o.

Ostrava-Hrabuvka, 70030, Czechia

Location

ACREDULA BENEDICTA s.r.o.

Pardubice, 53002, Czechia

Location

Fakultní nemocnice Plzeň

Pilsen, 30460, Czechia

Location

KASMED, s.r.o.

Tábor, 39002, Czechia

Location

MŮJ ALERGOLOG s.r.o.

Trutnov, 54101, Czechia

Location

CIMS Studienzentrum Bamberg, GmbH

Bamberg, 96049, Germany

Location

Charité - Universitaetsmedizin Berlin Klinik fuer Dermatologie, Venerologie und Allergologie/ Abteilung Allergologie und Immunologie

Berlin, 10117, Germany

Location

Praxis Dr. Petra El-Naib

Chemnitz, 09130, Germany

Location

HNO-Praxis Dr. Udo Schaefer

Dresden, 01067, Germany

Location

Klinische Forschung Dresden GmbH

Dresden, 01069, Germany

Location

Praxis fuer HNO und Allergologie

Dresden, 01139, Germany

Location

Universitaetsklinikum Carl Gustav Carus an der TU Dresden

Dresden, 01307, Germany

Location

HNO-Praxis Dr. Uta Thieme

Duisburg, 47051, Germany

Location

RKM740 Hals-Nasen-Ohrenheilkunde

Düsseldorf, 40549, Germany

Location

Gemeinschaftspraxis Ruhr

Essen, 45277, Germany

Location

Medizentrum Essen Borbeck

Essen, 45355, Germany

Location

Medaimun GmbH

Frankfurt am Main, 60596, Germany

Location

medicoKIT GmbH

Goch, 47574, Germany

Location

Klinische Forschung Hamburg GmbH

Hamburg, 20253, Germany

Location

Hamburger Institut für Therapieforschung GmbH

Hamburg, 20354, Germany

Location

Velocity Clinical Research Hamburg

Hamburg, 22143, Germany

Location

Praxis Dres. med. Florian Heimlich und Angelika Witzel-Heimlich

Heidelberg, 69126, Germany

Location

HNO-Praxis Landsberg

Landsberg, 06188, Germany

Location

Praxis fuer Pneumologie und Allergologie

Leipzig, 04299, Germany

Location

Sektion Rhinologie/Allergologie Klinik fuer HNO-Heilkunde, UKGM - Marburg

Marburg, 35043, Germany

Location

Beldio Research GmbH

Memmingen, 87700, Germany

Location

Facharztpraxis Dr. med. Jan-Christof Bohn

Mittweida, 09648, Germany

Location

Ballenberger, Freytag, Wenisch Institut fuer klinische Forschung GmbH

Neu-Isenburg, 63263, Germany

Location

Studienzentrum Maerkisch-Oderland

Neuenhagen, 15366, Germany

Location

KliFOs - Klinische Forschung Osnabrueck

Osnabrück, 49074, Germany

Location

Studienzentrum Dr. Sabine Lassmann

Saalfeld, 07318, Germany

Location

Klinische Forschung Schwerin GmbH

Schwerin, 19055, Germany

Location

Klinikum Stuttgart - Krankenhaus Bad Cannstatt (KBC) - Frauenklinik

Stuttgart, 70374, Germany

Location

Dres. med. Josef und Wilma Grosskopf

Wallerfing, 94574, Germany

Location

Gróf Tisza István Kórház Rendelőintézet MEDIDOCUMENT Kereskedelmi és Szolgáltató Betéti Társaság

Berettyóújfalu, 4100, Hungary

Location

Clinexpert Kft

Budapest, 1033, Hungary

Location

HiTech Medical Kft.

Budapest, 1064, Hungary

Location

Pecsi Tudomanyegyetem Altalanos Orvostudomanyi Kar

Pécs, 7621, Hungary

Location

Prywatny Gabinet Internistyczno - Alergologiczny

Bialystok, 15010, Poland

Location

Allergy Clinic Homeo Medicus

Bialystok, 15687, Poland

Location

Centrum Medyczne Czestochowa - PRATIA - PPDS

Częstochowa, 42200, Poland

Location

Centrum Medyczne Pratia Katowice

Katowice, 40081, Poland

Location

Specjalistyczna Praktyka Lekarska dr n. med. Joanna Orlicz-Widawska

Katowice, 40338, Poland

Location

ETG Kielce

Kielce, 25355, Poland

Location

Centrum Nowoczesnych Terapii Dobry Lekarz Sp. z o.o.

Krakow, 31011, Poland

Location

Krakowskie Centrum Medyczne

Krakow, 31501, Poland

Location

Malopolskie Centrum Alergologii

Krakow, 31624, Poland

Location

Uniwersytecki Szpital Kliniczny im. Barlickiego, Poradnia alergologii i chorob pluc

Lodz, 90153, Poland

Location

ETG Łódz

Lodz, 90302, Poland

Location

Clinical Best Solutions Sp. Z O.O. Spółka Komandytowa

Lublin, 20078, Poland

Location

Centrum Alergologii Teresa Hofman Sp. z o.o.

Poznan, 60214, Poland

Location

Specjalistyczna Przychodnia Lekarska ALERGO-MED Sp. z.o.o.

Poznan, 61578, Poland

Location

EMED Centrum Uslug Medycznych Ewa Śmiałek

Rzeszów, 35205, Poland

Location

ETG Skierniewice

Skierniewice, 96100, Poland

Location

ALERGO-MED Specjalistyczna Przychodnia Lekarska Sp. z.o.o

Tarnów, 33100, Poland

Location

Specjalistyczne Centrum Medyczne Centermed Sp. z o.o.

Tarnów, 33100, Poland

Location

IRMED Irena Wojciechowska

Warsaw, 01157, Poland

Location

WK Medical Service Sp. z o.o.

Warsaw, 02-119, Poland

Location

"ALL-MED" Specjalistyczna Opieka Medyczna, Medyczny Instytut Badawczy

Wroclaw, 53201, Poland

Location

Michał Bogacki - DOBROSTAN

Wroclaw, 53301, Poland

Location

Niepubliczny Zakład Opieki Zdrowotnej Przychodnia Lekarska Hipokrates Sp. z o.o.

Zabrze, 41800, Poland

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

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• 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: September 1, 2022
• First Posted: September 15, 2022
• Study Start: October 11, 2022
• Primary Completion: November 1, 2023
• Study Completion: November 1, 2023
• Last Updated: April 2, 2025
• Results First Posted: April 2, 2025

Record last verified: 2025-02

Locations

DE (29); CZ (9); PL (23); US (33); HU (4); AU (4)