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

Primary Purpose

Seasonal Allergic Rhinitis, Rhinoconjunctivitis

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
PQ Grass
Placebo
Sponsored by
Allergy Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Seasonal Allergic Rhinitis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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 2021]).

  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).
  10. Grass specific IgE (immunoglobulin E) class ≥2 as documented by an ImmunoCAP test at screening.
  11. 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.

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) 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.

  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:

    1. Severe asthma (as per the current GINA guidelines [GINA, 2021]).
    2. Uncontrolled or poorly controlled asthma as per the current GINA guidelines (GINA, 2021).
    3. 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, 2021).
    4. 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.
    5. Prior intubation/mechanical ventilation for asthma.
    6. Emergency room visit or hospitalisation for asthma in the 12 months prior to screening or Visit 2.
    7. Any history of a life-threatening asthma attack.
    8. FEV1 <70% of predicted or FEV1/FVC ≤75% or PEFR <70% of predicted with or without controller medications at screening or Visit 2.
  10. Presence non-atopic rhinitis and/or rhino-sinusitis (with or without polyps).
  11. Presence of nasal polyps and/or chronic sinusitis.
  12. Presence of any acute or chronic ocular disorder, other than allergic conjunctivitis.
  13. Eye surgery within the past 6 months.
  14. Presence of any skin conditions (e.g., skin abnormalities, tattoos etc.), which might interfere with the interpretation of the SPT results.
  15. Clinical history of Type I diabetes or poorly controlled Type II diabetes.
  16. Moderate to severe upper or lower respiratory infections requiring medication within 14 days before screening (Visit 1) or Visit 2.
  17. Presence of acute or chronic infection, fever or inflammation at screening or Visit 2.
  18. Clinical history of severe systemic reaction or serious systemic reaction in response to AIT (allergen immunotherapy) in the past.
  19. Clinical history of severe or life-threatening anaphylactic reactions to foods, insect venom, exercise, drugs or idiopathic anaphylaxis.
  20. Clinical history of allergy, hypersensitivity or intolerance to the excipients of the investigational drug/placebo.
  21. Clinical history of allergy, hypersensitivity or intolerance to the relief medications (for relief of allergy symptoms during Period 3) provided for use in this clinical trial.
  22. Clinical history of hereditary angioedema.
  23. Unable to receive epinephrine therapy (i.e., use of epinephrine is contraindicated such as in subjects with hyperthyroidism, uncontrolled hypertension, cardiac arrhythmias, closed angle glaucoma or subjects taking other sympathomimetics).
  24. Tyrosine metabolism disorders, especially tyrosinemia and alkaptonuria.
  25. Clinical history of drug or alcohol abuse, which, in the Investigator's opinion, could interfere with the subject's ability to participate in the clinical trial.
  26. Subjects who have suspicion or symptoms of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection (as assessed by the Investigator) or who have had unprotected contact with a confirmed case of COVID-19 (coronavirus disease 2019) in the 2 weeks prior to screening or Visit 2 (based on the Investigator's discretion).
  27. Subjects who were hospitalised for COVID-19 within 6 months prior to screening or Visit 2.
  28. Any history of AIT for grass pollen allergy in the past or history of AIT for any other type of allergy (excluding food allergy) in the past 5 years.
  29. Inability to adhere to the washout periods listed in the protocol, with respect to screening and to refrain from using the medications indicated until after Visit 11.
  30. Treatment with a preparation containing MPL (monophosphoryl lipid-A) (e.g., Cervarix, Shingrix, Fendrix) within 2 years prior to Visit 1 and until after completion of Visit 11 (with the exception of the investigational drug).
  31. Previous history of epinephrine auto-injector use.
  32. β-blocker medication (local or systemic, including eye drops) for any indication.
  33. Monoamine oxidase inhibitors and tricyclic antidepressants. Please note: Tricyclic antidepressants should be avoided at least 2 weeks prior to screening.
  34. Any previous therapy (within the previous 5 years) or current therapy with anti IgE (e.g., omalizumab [Xolair]) or anti-interleukins (e.g., mepolizumab).
  35. Current or past therapy (within the previous 5 years) with any other immunomodulary biologics.
  36. Unable to refrain from any vaccination (including influenza vaccine and COVID-19 vaccine) during the clinical trial (unless administered >30 days prior to randomisation).

    Please note: Emergency vaccinations (e.g., tetanus due to injury) can be administered at any time. Booster vaccinations (only) for COVID-19 can be administered during the clinical trial apart from during the treatment period. There should be at least 14 days interval from the last administration of the investigational drug/placebo prior to administration of a COVID-19 booster injection.

  37. Participation in a clinical research trial with any investigational drug within 4 weeks of Visit 1 or concomitantly with this clinical trial.

    Please note: The period of exclusion begins at the time of the last visit of the prior clinical research trial. Subjects consented and screened, but not dosed in the prior clinical research trial are not excluded.

  38. Personal, financial or other dependent relationship (e.g., employee or immediate relative) with the clinical trial site, Sponsor, Sponsor's representative, or another individual who has access to the clinical trial protocol.
  39. Vulnerable subjects or those in judicial or governmental detention, detainment or imprisonment in a public institution.
  40. Subjects likely to have prolonged periods of absence (e.g., business or personal travel) during the GPS defined as:

    • Absence of a total of 22 days or more in similar geographical regions (as determined by the Investigator), with no single trip in a similar geographical region exceeding 14 days.
    • Absence of a total of 15 days or more in non-similar geographic regions (as determined by the Investigator), with no single trip in a non-similar geographical region exceeding 7 days.
  41. Have changed residence to a different geographical region(s) since the last GPS.

Exception: The old and new residences are in the same or similar geographical region as determined by the Investigator.

Sites / Locations

  • Velocity Clinical Research Denver
  • Allergy and Asthma Associates of Bluegrass
  • Family Allergy Asthma Research Institute
  • Allergy & Asthma Specialists PSC
  • Paul A. Shapero M.D.
  • Chesapeake Clinical Research Inc
  • Respiratory Medicine Research Institute of Michigan
  • Clinical Research of The Ozarks Inc - Warrensburg
  • Montana Medical Research
  • Nebraska Medical Research Institute, The Asthma & Allergy Center
  • Parikh Institute for Research LLC
  • Atlantic Research Center LLC
  • Weiss Medical
  • Cincinnati Allergy and Asthma Center
  • Bernstein Clinical Research Center, LLC
  • Optimed Research Ltd
  • Oklahoma Institute of Allergy and Asthma Clinical Research, LLC - CRN - PPDS
  • Velocity Clinical Research, Inc
  • Velocity Clinical Research - Medford - ERN - PPDS
  • Northwest Research Center
  • Allergy and Clinical Immunology Associates
  • Bellingham Asthma Allergy and Immunology Clinic
  • Allergy, Asthma & Sinus Center, S.C.
  • University of Wisconsin Clinical Science Center
  • Medizinische Universitaet Innsbruck - Universitatsklinik fuer Dermatologie, Venerologie und Allergologie
  • Medizinische Universitat Wien (Medical University of Vienna)
  • Ambulatorium für Allergie und klinische Immunologie AAKI
  • Fakultní nemocnice u sv. Anny v Brně
  • Alergopraktik, s.r.o.
  • Alergologie a imunologie MUDr. Hofstetr
  • Alergoimuno s.r.o.
  • ACREDULA BENEDICTA s.r.o.
  • Fakultní nemocnice Plzeň
  • MŮJ ALERGOLOG s.r.o.
  • KASMED, s.r.o.
  • MUDr. Jana Poloniová - alergologie a klinická imunologie
  • CIMS Studienzentrum Bamberg, GmbH
  • Charité - Universitaetsmedizin Berlin Klinik fuer Dermatologie, Venerologie und Allergologie/ Abteilung Allergologie und Immunologie
  • Praxis Dr. Petra El-Naib
  • HNO-Praxis Dr. Udo Schaefer
  • Klinische Forschung Dresden GmbH
  • Praxis fuer HNO und Allergologie
  • Universitaetsklinikum Carl Gustav Carus an der TU Dresden
  • RKM740 Hals-Nasen-Ohrenheilkunde
  • HNO-Praxis Dr. Uta Thieme
  • Medizentrum Essen Borbeck
  • Medaimun GmbH
  • Klinische Forschung Hamburg GmbH
  • Hamburger Institut für Therapieforschung GmbH
  • Velocity Clinical Research Hamburg
  • Praxis Dres. med. Florian Heimlich und Angelika Witzel-Heimlich
  • HNO-Praxis Landsberg
  • Praxis fuer Pneumologie und Allergologie
  • Sektion Rhinologie/Allergologie Klinik fuer HNO-Heilkunde, UKGM - Marburg
  • Beldio Research GmbH
  • Facharztpraxis Dr. med. Jan-Christof Bohn
  • Ballenberger, Freytag, Wenisch Institut fuer klinische Forschung GmbH
  • Studienzentrum Maerkisch-Oderland
  • KliFOs - Klinische Forschung Osnabrueck
  • Studienzentrum Dr. Sabine Lassmann
  • Klinische Forschung Schwerin GmbH
  • Klinikum Stuttgart - Krankenhaus Bad Cannstatt (KBC) - Frauenklinik
  • Dres. med. Josef und Wilma Grosskopf
  • Gróf Tisza István Kórház Rendelőintézet MEDIDOCUMENT Kereskedelmi és Szolgáltató Betéti Társaság
  • Clinexpert Kft
  • HiTech Medical Kft.
  • Pecsi Tudomanyegyetem Altalanos Orvostudomanyi Kar
  • Prywatny Gabinet Internistyczno - Alergologiczny
  • Allergy Clinic Homeo Medicus
  • Centrum Medyczne Czestochowa - PRATIA - PPDS
  • Centrum Medyczne Pratia Katowice
  • Specjalistyczna Praktyka Lekarska dr n. med. Joanna Orlicz-Widawska
  • ETG Kielce
  • Centrum Nowoczesnych Terapii Dobry Lekarz Sp. z o.o.
  • Krakowskie Centrum Medyczne
  • Malopolskie Centrum Alergologii
  • Clinical Best Solutions Sp. Z O.O. Spółka Komandytowa
  • Centrum Alergologii Teresa Hofman Sp. z o.o.
  • Specjalistyczna Przychodnia Lekarska ALERGO-MED Sp. z.o.o.
  • EMED Centrum Uslug Medycznych Ewa Śmiałek
  • ETG Skierniewice
  • ALERGO-MED Specjalistyczna Przychodnia Lekarska Sp. z.o.o
  • Specjalistyczne Centrum Medyczne Centermed Sp. z o.o.
  • IRMED Irena Wojciechowska
  • "ALL-MED" Specjalistyczna Opieka Medyczna, Medyczny Instytut Badawczy
  • Michał Bogacki - DOBROSTAN
  • Niepubliczny Zakład Opieki Zdrowotnej Przychodnia Lekarska Hipokrates Sp. z o.o.
  • Uniwersytecki Szpital Kliniczny im. Barlickiego, Poradnia alergologii i chorob pluc
  • ETG Łódz

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

PQ Grass

Placebo

Arm Description

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

6 subcutaneous injections of placebo

Outcomes

Primary Outcome Measures

Combined symptom and medication score (CSMS) averaged over the peak grass pollen season (GPS)
6 individual symptoms assessed in a 4 point severity scale (0-No symptoms to 3-Severe symptoms) and combined with relief medication use assessed using a 4 point severity scale (0=No relief medication, 1=anti-histamine use, 2=nasal corticosteroid use, and 3=oral corticosteroid use).

Secondary Outcome Measures

Serum grass specific IgG4 (immunoglobulin G4) at Visit 7 compared to baseline.
The number of well days during the peak GPS.
Rhinoconjunctivitis Quality of Life Questionnaire with standardised activities (RQLQ(S)) measured within the peak GPS
Rhinoconjunctivitis quality of life questionnaire with standardised activities - RQLQ(S). 7-point scale (0 = not impaired at all - 6 = severely impaired). Scoring available: higher scores reflect lower quality of life.
Frequency, severity and relationship of AEs (adverse event) to treatment
Frequency of AEs leading to premature discontinuation from treatment or clinical trial
Frequency of AESI (adverse events of special interest)
Changes in serum chemistry values between screening and Visit 11
Including sodium, potassium and chloride concentration (mmol/L)
Changes in serum chemistry values between screening and Visit 11
Including glucose, uric acid, urea, phosphorus and cholesterol concentration (mmol/L)
Changes in serum chemistry values between screening and Visit 11
Including calcium, creatinine and total bilirubin concentration (µmol/L)
Changes in serum chemistry values between screening and Visit 11
Including total protein and albumin concentration (g/L)
Changes in serum chemistry values between screening and Visit 11
Including alkaline phosphatase, LDH (lactate dehydrogenase), AST (aspartate aminotransferase), ALT (alanine aminotransferase) and GGT (gamma-glutamyl transferase) (U/L)
Changes in serum chemistry values between screening and Visit 11
Including CRP (C-reactive protein) (mg/L)
Changes in haematology values between screening and Visit 11
Including total RBC (red blood cells) and differential (10^12/L)
Changes in haematology values between screening and Visit 11
Including total WBC (white blood cells) and differential and platelet count (10^9/L)
Changes in haematology values between screening and Visit 11 - Haemoglobin
Haemoglobin concentration
Changes in clinical laboratory values (urinalysis) between screening and Visit 11
Urinalysis (using a urine dip-stick) pH - Results will be assessed by the investigators as clinical significant or not
Changes in clinical laboratory values (urinalysis) between screening and Visit 11
Urinalysis (using a urine dip-stick) protein, glucose, bilirubin, blood and leukocytes - Results will show zero, traces, +1, +2, +3, +4 Note: Microscopic examination will be conducted if protein, leukocytes and/or blood are detected. If needed, microscopic examination will include WBC, RBC, casts, and bacteria.
Changes in clinical laboratory values (urinalysis) between screening and Visit 11
Urinalysis (using a urine dip-stick) Ketones, nitrite, urobilinogen - Results will show negative or positive Note: Microscopic examination will be conducted if nitrite are detected. If needed, microscopic examination will include WBC, RBC, casts, and bacteria.
Changes in vital signs at all treatment visits
Systolic and diastolic blood pressure
Combined symptom and medication score (CSMS) averaged over the entire (or truncated) grass pollen season (GPS)
6 individual symptoms assessed in a 4 point severity scale (0-No symptoms to 3-Severe symptoms) and combined with relief medication use assessed using a 4 point severity scale (0=No relief medication, 1=anti-histamine use, 2=nasal corticosteroid use, and 3=oral corticosteroid use)
Daily symptom score (dSS) component of the CSMS averaged over the peak GPS and entire (or truncated) GPS
Sum of the scores (0-No symptoms to 3-Severe symptoms) for the 6 individual symptoms assessed in CSMS divided by 6
Daily medication score (dMS) component of the CSMS averaged over the peak GPS and entire (or truncated) GPS
Score 0 (no relief medication) to 3 (highest step relief medication) per day; based on at least 1 dose of the medication of the highest step taken that day

Full Information

First Posted
September 1, 2022
Last Updated
July 31, 2023
Sponsor
Allergy Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT05540717
Brief Title
Efficacy and Safety of PQ Grass in Subjects With Seasonal Allergic Rhinitis and/or Rhinoconjunctivitis Induced by Grass Pollen
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 11, 2022 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergy Therapeutics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seasonal Allergic Rhinitis, Rhinoconjunctivitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1204 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PQ Grass
Arm Type
Experimental
Arm Description
6 subcutaneous injections of active treatment (900, 2700, 6000, 6000, 6000 and 6000 SU sequentially) to achieve a cumulative nominal dose of 27600 SU
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
6 subcutaneous injections of placebo
Intervention Type
Biological
Intervention Name(s)
PQ Grass
Intervention Description
Suspension for Injection
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Solution for injection
Primary Outcome Measure Information:
Title
Combined symptom and medication score (CSMS) averaged over the peak grass pollen season (GPS)
Description
6 individual symptoms assessed in a 4 point severity scale (0-No symptoms to 3-Severe symptoms) and combined with relief medication use assessed using a 4 point severity scale (0=No relief medication, 1=anti-histamine use, 2=nasal corticosteroid use, and 3=oral corticosteroid use).
Time Frame
Approximately 2-5 weeks
Secondary Outcome Measure Information:
Title
Serum grass specific IgG4 (immunoglobulin G4) at Visit 7 compared to baseline.
Time Frame
Approximately 16-22 weeks
Title
The number of well days during the peak GPS.
Time Frame
Approximately 10 weeks. Duration of the Peak Grass pollen season (GPS) to be determined as per pollen counts within the GPS
Title
Rhinoconjunctivitis Quality of Life Questionnaire with standardised activities (RQLQ(S)) measured within the peak GPS
Description
Rhinoconjunctivitis quality of life questionnaire with standardised activities - RQLQ(S). 7-point scale (0 = not impaired at all - 6 = severely impaired). Scoring available: higher scores reflect lower quality of life.
Time Frame
Up to approximately 6 months
Title
Frequency, severity and relationship of AEs (adverse event) to treatment
Time Frame
Up to 1 year
Title
Frequency of AEs leading to premature discontinuation from treatment or clinical trial
Time Frame
Up to 1 year
Title
Frequency of AESI (adverse events of special interest)
Time Frame
Up to 1 year
Title
Changes in serum chemistry values between screening and Visit 11
Description
Including sodium, potassium and chloride concentration (mmol/L)
Time Frame
8 months approximately
Title
Changes in serum chemistry values between screening and Visit 11
Description
Including glucose, uric acid, urea, phosphorus and cholesterol concentration (mmol/L)
Time Frame
8 months approximately
Title
Changes in serum chemistry values between screening and Visit 11
Description
Including calcium, creatinine and total bilirubin concentration (µmol/L)
Time Frame
8 months approximately
Title
Changes in serum chemistry values between screening and Visit 11
Description
Including total protein and albumin concentration (g/L)
Time Frame
8 months approximately
Title
Changes in serum chemistry values between screening and Visit 11
Description
Including alkaline phosphatase, LDH (lactate dehydrogenase), AST (aspartate aminotransferase), ALT (alanine aminotransferase) and GGT (gamma-glutamyl transferase) (U/L)
Time Frame
8 months approximately
Title
Changes in serum chemistry values between screening and Visit 11
Description
Including CRP (C-reactive protein) (mg/L)
Time Frame
8 months approximately
Title
Changes in haematology values between screening and Visit 11
Description
Including total RBC (red blood cells) and differential (10^12/L)
Time Frame
8 months approximately
Title
Changes in haematology values between screening and Visit 11
Description
Including total WBC (white blood cells) and differential and platelet count (10^9/L)
Time Frame
8 months approximately
Title
Changes in haematology values between screening and Visit 11 - Haemoglobin
Description
Haemoglobin concentration
Time Frame
8 months approximately
Title
Changes in clinical laboratory values (urinalysis) between screening and Visit 11
Description
Urinalysis (using a urine dip-stick) pH - Results will be assessed by the investigators as clinical significant or not
Time Frame
8 months approximately
Title
Changes in clinical laboratory values (urinalysis) between screening and Visit 11
Description
Urinalysis (using a urine dip-stick) protein, glucose, bilirubin, blood and leukocytes - Results will show zero, traces, +1, +2, +3, +4 Note: Microscopic examination will be conducted if protein, leukocytes and/or blood are detected. If needed, microscopic examination will include WBC, RBC, casts, and bacteria.
Time Frame
8 months approximately
Title
Changes in clinical laboratory values (urinalysis) between screening and Visit 11
Description
Urinalysis (using a urine dip-stick) Ketones, nitrite, urobilinogen - Results will show negative or positive Note: Microscopic examination will be conducted if nitrite are detected. If needed, microscopic examination will include WBC, RBC, casts, and bacteria.
Time Frame
8 months approximately
Title
Changes in vital signs at all treatment visits
Description
Systolic and diastolic blood pressure
Time Frame
7 months approximately
Title
Combined symptom and medication score (CSMS) averaged over the entire (or truncated) grass pollen season (GPS)
Description
6 individual symptoms assessed in a 4 point severity scale (0-No symptoms to 3-Severe symptoms) and combined with relief medication use assessed using a 4 point severity scale (0=No relief medication, 1=anti-histamine use, 2=nasal corticosteroid use, and 3=oral corticosteroid use)
Time Frame
Time Frame: Approximately 10 weeks
Title
Daily symptom score (dSS) component of the CSMS averaged over the peak GPS and entire (or truncated) GPS
Description
Sum of the scores (0-No symptoms to 3-Severe symptoms) for the 6 individual symptoms assessed in CSMS divided by 6
Time Frame
Time Frame: Time Frame: Approximately 10 weeks. Duration of the Peak Grass pollen season (GPS) to be determined as per pollen counts within the GPS
Title
Daily medication score (dMS) component of the CSMS averaged over the peak GPS and entire (or truncated) GPS
Description
Score 0 (no relief medication) to 3 (highest step relief medication) per day; based on at least 1 dose of the medication of the highest step taken that day
Time Frame
Time Frame: Approximately 10 weeks. Duration of the Peak Grass pollen season (GPS) to be determined as per pollen counts within the GPS

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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. 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. Presence of acute or chronic infection, fever or inflammation at screening or Visit 2. Clinical history of severe systemic reaction or serious systemic reaction in response to AIT (allergen immunotherapy) in the past. Clinical history of severe or life-threatening anaphylactic reactions to foods, insect venom, exercise, drugs or idiopathic anaphylaxis. Clinical history of allergy, hypersensitivity or intolerance to the excipients of the investigational drug/placebo. Clinical history of allergy, hypersensitivity or intolerance to the relief medications (for relief of allergy symptoms during Period 3) provided for use in this clinical trial. Clinical history of hereditary angioedema. Unable to receive epinephrine therapy (i.e., use of epinephrine is contraindicated such as in subjects with hyperthyroidism, uncontrolled hypertension, cardiac arrhythmias, closed angle glaucoma or subjects taking other sympathomimetics). Tyrosine metabolism disorders, especially tyrosinemia and alkaptonuria. Clinical history of drug or alcohol abuse, which, in the Investigator's opinion, could interfere with the subject's ability to participate in the clinical trial. Subjects who have suspicion or symptoms of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection (as assessed by the Investigator) or who have had unprotected contact with a confirmed case of COVID-19 (coronavirus disease 2019) in the 2 weeks prior to screening or Visit 2 (based on the Investigator's discretion). Subjects who were hospitalised for COVID-19 within 6 months prior to screening or Visit 2. Any history of AIT for grass pollen allergy in the past or history of AIT for any other type of allergy (excluding food allergy) in the past 5 years. Inability to adhere to the washout periods listed in the protocol, with respect to screening and to refrain from using the medications indicated until after Visit 11. Treatment with a preparation containing MPL (monophosphoryl lipid-A) (e.g., Cervarix, Shingrix, Fendrix) within 2 years prior to Visit 1 and until after completion of Visit 11 (with the exception of the investigational drug). Previous history of epinephrine auto-injector use. β-blocker medication (local or systemic, including eye drops) for any indication. Monoamine oxidase inhibitors and tricyclic antidepressants. Please note: Tricyclic antidepressants should be avoided at least 2 weeks prior to screening. Any previous therapy (within the previous 5 years) or current therapy with anti IgE (e.g., omalizumab [Xolair]) or anti-interleukins (e.g., mepolizumab). Current or past therapy (within the previous 5 years) with any other immunomodulary biologics. Unable to refrain from any vaccination (including influenza vaccine and COVID-19 vaccine) during the clinical trial (unless administered >30 days prior to randomisation). Please note: Emergency vaccinations (e.g., tetanus due to injury) can be administered at any time. Booster vaccinations (only) for COVID-19 can be administered during the clinical trial apart from during the treatment period. There should be at least 14 days interval from the last administration of the investigational drug/placebo prior to administration of a COVID-19 booster injection. Participation in a clinical research trial with any investigational drug within 4 weeks of Visit 1 or concomitantly with this clinical trial. Please note: The period of exclusion begins at the time of the last visit of the prior clinical research trial. Subjects consented and screened, but not dosed in the prior clinical research trial are not excluded. Personal, financial or other dependent relationship (e.g., employee or immediate relative) with the clinical trial site, Sponsor, Sponsor's representative, or another individual who has access to the clinical trial protocol. Vulnerable subjects or those in judicial or governmental detention, detainment or imprisonment in a public institution. Subjects likely to have prolonged periods of absence (e.g., business or personal travel) during the GPS defined as: Absence of a total of 22 days or more in similar geographical regions (as determined by the Investigator), with no single trip in a similar geographical region exceeding 14 days. Absence of a total of 15 days or more in non-similar geographic regions (as determined by the Investigator), with no single trip in a non-similar geographical region exceeding 7 days. Have changed residence to a different geographical region(s) since the last GPS. Exception: The old and new residences are in the same or similar geographical region as determined by the Investigator.
Facility Information:
Facility Name
Velocity Clinical Research Denver
City
Denver
State/Province
Colorado
ZIP/Postal Code
80209
Country
United States
Facility Name
Allergy and Asthma Associates of Bluegrass
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40509
Country
United States
Facility Name
Family Allergy Asthma Research Institute
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Allergy & Asthma Specialists PSC
City
Owensboro
State/Province
Kentucky
ZIP/Postal Code
42301
Country
United States
Facility Name
Paul A. Shapero M.D.
City
Bangor
State/Province
Maine
ZIP/Postal Code
04401
Country
United States
Facility Name
Chesapeake Clinical Research Inc
City
White Marsh
State/Province
Maryland
ZIP/Postal Code
21162
Country
United States
Facility Name
Respiratory Medicine Research Institute of Michigan
City
Ypsilanti
State/Province
Michigan
ZIP/Postal Code
48197
Country
United States
Facility Name
Clinical Research of The Ozarks Inc - Warrensburg
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65203
Country
United States
Facility Name
Montana Medical Research
City
Missoula
State/Province
Montana
ZIP/Postal Code
59808
Country
United States
Facility Name
Nebraska Medical Research Institute, The Asthma & Allergy Center
City
Bellevue
State/Province
Nebraska
ZIP/Postal Code
68123
Country
United States
Facility Name
Parikh Institute for Research LLC
City
Highland Park
State/Province
New Jersey
ZIP/Postal Code
08904
Country
United States
Facility Name
Atlantic Research Center LLC
City
Ocean City
State/Province
New Jersey
ZIP/Postal Code
07712
Country
United States
Facility Name
Weiss Medical
City
Riverdale
State/Province
New Jersey
ZIP/Postal Code
07457
Country
United States
Facility Name
Cincinnati Allergy and Asthma Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45209
Country
United States
Facility Name
Bernstein Clinical Research Center, LLC
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45236
Country
United States
Facility Name
Optimed Research Ltd
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43235
Country
United States
Facility Name
Oklahoma Institute of Allergy and Asthma Clinical Research, LLC - CRN - PPDS
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73131
Country
United States
Facility Name
Velocity Clinical Research, Inc
City
Grants Pass
State/Province
Oregon
ZIP/Postal Code
97527
Country
United States
Facility Name
Velocity Clinical Research - Medford - ERN - PPDS
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
Northwest Research Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97202
Country
United States
Facility Name
Allergy and Clinical Immunology Associates
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15241
Country
United States
Facility Name
Bellingham Asthma Allergy and Immunology Clinic
City
Bellingham
State/Province
Washington
ZIP/Postal Code
98225
Country
United States
Facility Name
Allergy, Asthma & Sinus Center, S.C.
City
Greenfield
State/Province
Wisconsin
ZIP/Postal Code
53228
Country
United States
Facility Name
University of Wisconsin Clinical Science Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
Medizinische Universitaet Innsbruck - Universitatsklinik fuer Dermatologie, Venerologie und Allergologie
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
Facility Name
Medizinische Universitat Wien (Medical University of Vienna)
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Ambulatorium für Allergie und klinische Immunologie AAKI
City
Wien
ZIP/Postal Code
1100
Country
Austria
Facility Name
Fakultní nemocnice u sv. Anny v Brně
City
Brno
ZIP/Postal Code
60200
Country
Czechia
Facility Name
Alergopraktik, s.r.o.
City
Jablonec Nad Nisou
ZIP/Postal Code
46601
Country
Czechia
Facility Name
Alergologie a imunologie MUDr. Hofstetr
City
Jihlava
ZIP/Postal Code
58601
Country
Czechia
Facility Name
Alergoimuno s.r.o.
City
Ostrava-Hrabuvka
ZIP/Postal Code
70030
Country
Czechia
Facility Name
ACREDULA BENEDICTA s.r.o.
City
Pardubice
ZIP/Postal Code
53002
Country
Czechia
Facility Name
Fakultní nemocnice Plzeň
City
Plzen
ZIP/Postal Code
30460
Country
Czechia
Facility Name
MŮJ ALERGOLOG s.r.o.
City
Trutnov
ZIP/Postal Code
54101
Country
Czechia
Facility Name
KASMED, s.r.o.
City
Tábor
ZIP/Postal Code
39002
Country
Czechia
Facility Name
MUDr. Jana Poloniová - alergologie a klinická imunologie
City
České Budějovice
ZIP/Postal Code
37001
Country
Czechia
Facility Name
CIMS Studienzentrum Bamberg, GmbH
City
Bamberg
ZIP/Postal Code
96049
Country
Germany
Facility Name
Charité - Universitaetsmedizin Berlin Klinik fuer Dermatologie, Venerologie und Allergologie/ Abteilung Allergologie und Immunologie
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Praxis Dr. Petra El-Naib
City
Chemnitz
ZIP/Postal Code
09130
Country
Germany
Facility Name
HNO-Praxis Dr. Udo Schaefer
City
Dresden
ZIP/Postal Code
01067
Country
Germany
Facility Name
Klinische Forschung Dresden GmbH
City
Dresden
ZIP/Postal Code
01069
Country
Germany
Facility Name
Praxis fuer HNO und Allergologie
City
Dresden
ZIP/Postal Code
01139
Country
Germany
Facility Name
Universitaetsklinikum Carl Gustav Carus an der TU Dresden
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
RKM740 Hals-Nasen-Ohrenheilkunde
City
Duesseldorf
ZIP/Postal Code
40549
Country
Germany
Facility Name
HNO-Praxis Dr. Uta Thieme
City
Duisburg
ZIP/Postal Code
47051
Country
Germany
Facility Name
Medizentrum Essen Borbeck
City
Essen
ZIP/Postal Code
45355
Country
Germany
Facility Name
Medaimun GmbH
City
Frankfurt am Main
ZIP/Postal Code
60596
Country
Germany
Facility Name
Klinische Forschung Hamburg GmbH
City
Hamburg
ZIP/Postal Code
20253
Country
Germany
Facility Name
Hamburger Institut für Therapieforschung GmbH
City
Hamburg
ZIP/Postal Code
20354
Country
Germany
Facility Name
Velocity Clinical Research Hamburg
City
Hamburg
ZIP/Postal Code
22143
Country
Germany
Facility Name
Praxis Dres. med. Florian Heimlich und Angelika Witzel-Heimlich
City
Heidelberg
ZIP/Postal Code
69126
Country
Germany
Facility Name
HNO-Praxis Landsberg
City
Landsberg
ZIP/Postal Code
06188
Country
Germany
Facility Name
Praxis fuer Pneumologie und Allergologie
City
Leipzig
ZIP/Postal Code
04299
Country
Germany
Facility Name
Sektion Rhinologie/Allergologie Klinik fuer HNO-Heilkunde, UKGM - Marburg
City
Marburg
ZIP/Postal Code
35043
Country
Germany
Facility Name
Beldio Research GmbH
City
Memmingen
ZIP/Postal Code
87700
Country
Germany
Facility Name
Facharztpraxis Dr. med. Jan-Christof Bohn
City
Mittweida
ZIP/Postal Code
09648
Country
Germany
Facility Name
Ballenberger, Freytag, Wenisch Institut fuer klinische Forschung GmbH
City
Neu Isenburg
ZIP/Postal Code
63263
Country
Germany
Facility Name
Studienzentrum Maerkisch-Oderland
City
Neuenhagen
ZIP/Postal Code
15366
Country
Germany
Facility Name
KliFOs - Klinische Forschung Osnabrueck
City
Osnabrück
ZIP/Postal Code
49074
Country
Germany
Facility Name
Studienzentrum Dr. Sabine Lassmann
City
Saalfeld
ZIP/Postal Code
07318
Country
Germany
Facility Name
Klinische Forschung Schwerin GmbH
City
Schwerin
ZIP/Postal Code
19055
Country
Germany
Facility Name
Klinikum Stuttgart - Krankenhaus Bad Cannstatt (KBC) - Frauenklinik
City
Stuttgart
ZIP/Postal Code
70374
Country
Germany
Facility Name
Dres. med. Josef und Wilma Grosskopf
City
Wallerfing
ZIP/Postal Code
94574
Country
Germany
Facility Name
Gróf Tisza István Kórház Rendelőintézet MEDIDOCUMENT Kereskedelmi és Szolgáltató Betéti Társaság
City
Berettyóújfalu
ZIP/Postal Code
4100
Country
Hungary
Facility Name
Clinexpert Kft
City
Budapest
ZIP/Postal Code
1033
Country
Hungary
Facility Name
HiTech Medical Kft.
City
Budapest
ZIP/Postal Code
1064
Country
Hungary
Facility Name
Pecsi Tudomanyegyetem Altalanos Orvostudomanyi Kar
City
Pécs
ZIP/Postal Code
7621
Country
Hungary
Facility Name
Prywatny Gabinet Internistyczno - Alergologiczny
City
Białystok
ZIP/Postal Code
15010
Country
Poland
Facility Name
Allergy Clinic Homeo Medicus
City
Białystok
ZIP/Postal Code
15687
Country
Poland
Facility Name
Centrum Medyczne Czestochowa - PRATIA - PPDS
City
Częstochowa
ZIP/Postal Code
42200
Country
Poland
Facility Name
Centrum Medyczne Pratia Katowice
City
Katowice
ZIP/Postal Code
40081
Country
Poland
Facility Name
Specjalistyczna Praktyka Lekarska dr n. med. Joanna Orlicz-Widawska
City
Katowice
ZIP/Postal Code
40338
Country
Poland
Facility Name
ETG Kielce
City
Kielce
ZIP/Postal Code
25355
Country
Poland
Facility Name
Centrum Nowoczesnych Terapii Dobry Lekarz Sp. z o.o.
City
Kraków
ZIP/Postal Code
31011
Country
Poland
Facility Name
Krakowskie Centrum Medyczne
City
Kraków
ZIP/Postal Code
31501
Country
Poland
Facility Name
Malopolskie Centrum Alergologii
City
Kraków
ZIP/Postal Code
31624
Country
Poland
Facility Name
Clinical Best Solutions Sp. Z O.O. Spółka Komandytowa
City
Lublin
ZIP/Postal Code
20078
Country
Poland
Facility Name
Centrum Alergologii Teresa Hofman Sp. z o.o.
City
Poznań
ZIP/Postal Code
60214
Country
Poland
Facility Name
Specjalistyczna Przychodnia Lekarska ALERGO-MED Sp. z.o.o.
City
Poznań
ZIP/Postal Code
61578
Country
Poland
Facility Name
EMED Centrum Uslug Medycznych Ewa Śmiałek
City
Rzeszów
ZIP/Postal Code
35205
Country
Poland
Facility Name
ETG Skierniewice
City
Skierniewice
ZIP/Postal Code
96100
Country
Poland
Facility Name
ALERGO-MED Specjalistyczna Przychodnia Lekarska Sp. z.o.o
City
Tarnów
ZIP/Postal Code
33100
Country
Poland
Facility Name
Specjalistyczne Centrum Medyczne Centermed Sp. z o.o.
City
Tarnów
ZIP/Postal Code
33100
Country
Poland
Facility Name
IRMED Irena Wojciechowska
City
Warszawa
ZIP/Postal Code
01157
Country
Poland
Facility Name
"ALL-MED" Specjalistyczna Opieka Medyczna, Medyczny Instytut Badawczy
City
Wrocław
ZIP/Postal Code
53201
Country
Poland
Facility Name
Michał Bogacki - DOBROSTAN
City
Wrocław
ZIP/Postal Code
53301
Country
Poland
Facility Name
Niepubliczny Zakład Opieki Zdrowotnej Przychodnia Lekarska Hipokrates Sp. z o.o.
City
Zabrze
ZIP/Postal Code
41800
Country
Poland
Facility Name
Uniwersytecki Szpital Kliniczny im. Barlickiego, Poradnia alergologii i chorob pluc
City
Łódź
ZIP/Postal Code
90153
Country
Poland
Facility Name
ETG Łódz
City
Łódź
ZIP/Postal Code
90302
Country
Poland

12. IPD Sharing Statement

Learn more about this trial

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

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