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An Exploratory Study of PQ Grass 27600 SU

Primary Purpose

Rhinitis, Allergic, Seasonal

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
PQ Grass
Placebo Option 1
Placebo Option 2
Sponsored by
Allergy Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rhinitis, Allergic, Seasonal focused on measuring PQ Grass, Seasonal Allergic Rhinitis or Rhinoconjunctivitis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

- Informed Consent

  1. 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.
  2. Subject who has signed and dated the ICF.

    - Age:

  3. 18 to 65 years of age inclusive, at the time of signing the ICF.

    - Sex / Contraceptive requirements:

  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) or females of childbearing potential who agree to comply with the contraceptive requirements of the study protocol.

    - Subjects and general health characteristics:

  6. 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.
  7. 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]).

  8. 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.
  9. Grass specific IgE class ≥2 as documented by an ImmunoCAP test at screening.
  10. FEV1 ≥80% of predicted, with a FEV1/FVC ratio ≥70% and (PEFR) ≥75% predicted at screening.
  11. Subjects who have no suspicion or symptoms of SARS-CoV-2 infection (as assessed by the investigator) or who have had no contact with a confirmed case of COVID-19 in the past 2 weeks prior to screening and randomisation.

Exclusion Criteria (include amongst others):

- Medical conditions:

  1. Pregnant or lactating subject.
  2. 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).

  3. Subjects with a positive SPT at US and EU sites in regions with relevant southern grass (Bahia grass, Bermuda grass or Johnson grass) exposure.
  4. 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.
  5. Presence of any medical condition that may reduce the ability to survive a serious allergic reaction.
  6. 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.
  7. 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.
  8. 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.
  9. Presence of non-atopic rhinitis and/or rhino-sinusitis (with or without polyps).
  10. Presence of nasal polyps and/or chronic sinusitis.
  11. Presence of any acute or chronic ocular disorder, other than allergic conjunctivitis, which could interfere with the evaluation of CPT.
  12. Eye surgery within the past 6 months.
  13. Presence of any skin conditions (e.g. skin abnormalities, tattoos) which might interfere with the interpretation of the SPT results.
  14. Clinical history of Type I diabetes. Subjects with well-controlled Type II diabetes will be allowed to participate at the discretion of the investigator.
  15. Any acute infection (including upper respiratory tract infections in the 14 days prior to Visit 2), which in the opinion of the investigator may pose a safety risk to the subject.
  16. Clinical history of severe or serious systemic reaction in response to AIT treatment in the past.
  17. Clinical history of severe or life-threatening anaphylactic reactions to foods, insect venom, exercise, drugs or idiopathic anaphylaxis.
  18. Clinical history of allergy, hypersensitivity or intolerance to the excipients of the IMP.
  19. Tyrosine metabolism disorders, especially tyrosinemia and alkaptonuria.

    - Prior/concomitant therapy:

  20. History of any allergen SIT.
  21. Inability to adhere to the washout periods for Prohibited Medications/Therapies with respect to Visit 1/1a and to refrain from using the medications indicated until after Visit 15.
  22. Treatment with a preparation containing MPL (e.g., Cervarix, Shingrix, Fendrix) within 2 years prior to Visit 1 and until after completion of Visit 15 (with the exception of the IMP).
  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 sympathomimetic).
  24. Previous history of epinephrine device use.
  25. β-blocker medication (including eye drops), for any indication.
  26. Monoamine oxidase inhibitors and tricyclic antidepressants. (Tricyclic antidepressants should be avoided at least 2 weeks prior to screening).
  27. Any previous therapy (within 12 months prior to screening) or current therapy with anti IgE (e.g., Xolair) or anti-interleukins (e.g., mepolizumab) or any other therapy with a biologic agent.
  28. Unable to refrain from any vaccination (including influenza and any potential vaccine for COVID-19) during the study (unless administered more than 30 days prior to randomisation). Please note: Emergency vaccinations (e.g., tetanus due to injury) can be administered at any time.
  29. Current or past therapy (within the previous 5 years) with immunosuppressant drugs or immunomodulatory biologics.

    Other exclusions

  30. Clinical history of drug or alcohol abuse which, in the investigator's opinion, could interfere with the subject's ability to participate in the study.
  31. Participation in a clinical research trial with any IMP within 4 weeks of Visit 1 or concomitantly with this study
  32. Personal, financial or other dependent relationship (e.g., employee or immediate relative) with the study site, Sponsor, Sponsor's representative, or another individual who has access to the study protocol.
  33. Vulnerable subjects or those in judicial or governmental detention, detainment or imprisonment in a public institution.
  34. Subjects likely to have prolonged periods of absence (e.g., business or personal travel) during the GPS defined as:

    • Absence of 22 days or more in similar or mixed geographic regions as determined by the investigator, with no single trip in a similar geographical region exceeding 14 days and no single trip in a non-similar geographical region exceeding 7 days,
    • Absence of 15 days or more in non-similar geographic regions as determined by the investigator, with no single trip exceeding 7 days.
  35. Have changed residence between geographical regions 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

  • Allergy and Asthma Associates of Bluegrass
  • Chesapeake Clinical Research, Inc.
  • Atlantic Research Center, LLC
  • Smith Allergy & Asthma Specialists
  • Corning Center for Clinical Research
  • Allergy Partners of Western North Carolina
  • Bernstein Clinical Research Center, LLC
  • Allergy Asthma & Sinus Center, S.C.
  • Universitatsmedizin Berlin - Charite Campus Mitte - Allergie Centrum Charite
  • Universitätsklinikum Carl Gustav Carus an der TU Dresden
  • ENT RESEARCH - Institut für klinische Studien
  • Medaimun GmbH
  • Hamburger Institut für Therapieforschung GmbH
  • Studienzentrum Dr. Sabine Laßmann

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Placebo Comparator

Placebo Comparator

Arm Label

PQ Grass Standard Dosing Regimen

PQ Grass Alternative Dosing Regimen

Placebo Option 1

Placebo option 2

Arm Description

Cumulative dose 27600 SU

Cumulative dose 27600 SU

Suspension for injection

Solution for injection

Outcomes

Primary Outcome Measures

CSMS (Combined symptom and medication score) 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

Secondary Outcome Measures

CSMS averaged over the entire (or truncated) GPS
6 individual symptoms assessed in a 4 point severity scale (0-No symptoms to 3-Severe symptoms)
Total combined score (TCS) averaged over the peak GPS
6 individual symptoms in a similar fashion to CSMS assessed in a 4 point severity scale (0-No symptoms to 3-Severe symptoms)
TCS averaged over entire (or truncated) GPS
6 individual symptoms in a similar fashion to CSMS assessed in a 4 point severity scale (0-No symptoms to 3-Severe symptoms)
Daily symptom score (dSS) of the CSMS averaged over the peak 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) of the CSMS averaged over the peak 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
dSS of the TCS 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 (i.e. ranging from 0 to 18)
dMS of the TCS 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
TSS during CPT, CSMS, TCS, dSS (for CSMS and TCS) and dMS (for CSMS and TCS) over the peak and entire (or truncated) GPS for subjects with a positive CPT at baseline.
CPT - Conjunctival provocation test - At screening, during randomization and pre-GPS
The probability of well days and severe days during the peak and entire (or truncated) GPS.
Pre-GPS (Visit 12) TSS measured during CPT
Pre-season
Serum Ig responses (total IgE; grass-specific IgE and IgG4; specific IgE/total IgE and specific IgE/specific IgG4) at Visit 12 and Visit 15.
RQLQ(S) measured within the GPS
Rhinoconjunctivitis quality of life questionnaire with standardised activities - RQLQ(S)
Frequency, severity and relationship of AEs to treatment
AEs - Adverse Events
Frequency of AEs leading to premature discontinuation from treatment or study
Frequency of AESI
AESI - Adverse events of special interest
Changes in serum chemistry values between screening and Visit 15
Including sodium, potassium and chloride concentration
Changes in serum chemistry values between screening and Visit 15
Including Glucose, uric acid, urea, calcium, creatinine, total protein, phosphorus, cholesterol, albumin and total bilirubin concentration
Changes in serum chemistry values between screening and Visit 15
Including alkaline phosphatase, LDH, AST, ALT, GGT, CRP.
Changes in haematology values between screening and Visit 15 - RBC, WBC, Platelets
Including total WBC and differentials, total RBC, RBC indices and platelet count.
Changes in haematology values between screening and Visit 15 - Haemoglobin
Haemoglobin concentration
Changes in clinical laboratory values (urinalysis) between screening and Visit 15
Urinalysis (using a urine dip-stick) pH, protein, glucose, ketones, bilirubin, blood, nitrite, urobilinogen, leukocytes. Note: Microscopic examination will be conducted if protein, leukocytes, nitrite, and/or blood are detected. If needed, microscopic examination will include WBC, RBC, casts, and bacteria.
Changes in vital signs (all subjects) at all treatment visits - Blood pressure
systolic and diastolic blood pressure
Changes in vital signs (all subjects) at all treatment visits - Pulse rate
Changes in vital signs (all subjects) at all treatment visits - Respiratory rate
Changes in vital signs (all subjects) at all treatment visits - Body temperature
Changes in PEFR (only in subjects with past or current asthma) at all treatment visits
PEFR - peak expiratory flow rate

Full Information

First Posted
October 8, 2020
Last Updated
January 17, 2022
Sponsor
Allergy Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT04687059
Brief Title
An Exploratory Study of PQ Grass 27600 SU
Official Title
A Randomised, Double-blind, Placebo-controlled Exploratory Study to Explore the Efficacy and Safety of PQ Grass 27600 SU in Subjects With Seasonal Allergic Rhinitis and/or Rhinoconjunctivitis Induced by Grass Pollen Exposure
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
October 19, 2020 (Actual)
Primary Completion Date
August 18, 2021 (Actual)
Study Completion Date
October 28, 2021 (Actual)

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
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
PQGrass309 is a randomised, double-blind, placebo-controlled exploratory study to explore the efficacy and safety of PQ Grass 27600 SU in subjects with seasonal allergic rhinitis and/or rhinoconjunctivitis (SAR) induced by grass pollen exposure. The study is expected to be conducted in the United States (US) and the European Union (EU). The study will enrol enough subjects to allow treatment of approximately 150 subjects. The aim of this exploratory field study is to explore amongst others the following: The efficacy and safety (up to 6 months following treatment) of a cumulative dose of 27600 standardised units (SU) of PQ Grass in the treatment of grass pollen allergy. The expected average treatment effect on combined symptom and medication score.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
119 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PQ Grass Standard Dosing Regimen
Arm Type
Experimental
Arm Description
Cumulative dose 27600 SU
Arm Title
PQ Grass Alternative Dosing Regimen
Arm Type
Experimental
Arm Description
Cumulative dose 27600 SU
Arm Title
Placebo Option 1
Arm Type
Placebo Comparator
Arm Description
Suspension for injection
Arm Title
Placebo option 2
Arm Type
Placebo Comparator
Arm Description
Solution for injection
Intervention Type
Biological
Intervention Name(s)
PQ Grass
Intervention Description
Suspension for injection
Intervention Type
Drug
Intervention Name(s)
Placebo Option 1
Intervention Description
Suspension for injection
Intervention Type
Drug
Intervention Name(s)
Placebo Option 2
Intervention Description
Solution for injection
Primary Outcome Measure Information:
Title
CSMS (Combined symptom and medication score) 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
Time Frame
Approximately 2-5 weeks
Secondary Outcome Measure Information:
Title
CSMS averaged over the entire (or truncated) GPS
Description
6 individual symptoms assessed in a 4 point severity scale (0-No symptoms to 3-Severe symptoms)
Time Frame
Approximately 10 weeks
Title
Total combined score (TCS) averaged over the peak GPS
Description
6 individual symptoms in a similar fashion to CSMS assessed in a 4 point severity scale (0-No symptoms to 3-Severe symptoms)
Time Frame
Approximately 2-5 weeks
Title
TCS averaged over entire (or truncated) GPS
Description
6 individual symptoms in a similar fashion to CSMS assessed in a 4 point severity scale (0-No symptoms to 3-Severe symptoms)
Time Frame
Approximately 10 weeks
Title
Daily symptom score (dSS) of the CSMS averaged over the peak 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
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) of the CSMS averaged over the peak 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
Approximately 10 weeks. Duration of the Peak Grass pollen season (GPS) to be determined as per pollen counts within the GPS
Title
dSS of the TCS 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 (i.e. ranging from 0 to 18)
Time Frame
Approximately 10 weeks. Duration of the Peak Grass pollen season (GPS) to be determined as per pollen counts within the GPS
Title
dMS of the TCS 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
Approximately 10 weeks. Duration of the Peak Grass pollen season (GPS) to be determined as per pollen counts within the GPS
Title
TSS during CPT, CSMS, TCS, dSS (for CSMS and TCS) and dMS (for CSMS and TCS) over the peak and entire (or truncated) GPS for subjects with a positive CPT at baseline.
Description
CPT - Conjunctival provocation test - At screening, during randomization and pre-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
The probability of well days and severe days during the peak and entire (or truncated) 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
Pre-GPS (Visit 12) TSS measured during CPT
Description
Pre-season
Time Frame
Assessment Baseline (pre-GPS)
Title
Serum Ig responses (total IgE; grass-specific IgE and IgG4; specific IgE/total IgE and specific IgE/specific IgG4) at Visit 12 and Visit 15.
Time Frame
Approximately 10 weeks
Title
RQLQ(S) measured within the GPS
Description
Rhinoconjunctivitis quality of life questionnaire with standardised activities - RQLQ(S)
Time Frame
Approximately 10 weeks
Title
Frequency, severity and relationship of AEs to treatment
Description
AEs - Adverse Events
Time Frame
Up to 1 year
Title
Frequency of AEs leading to premature discontinuation from treatment or study
Time Frame
Up to 1 year
Title
Frequency of AESI
Description
AESI - Adverse events of special interest
Time Frame
Up to 1 year
Title
Changes in serum chemistry values between screening and Visit 15
Description
Including sodium, potassium and chloride concentration
Time Frame
6 months approximately
Title
Changes in serum chemistry values between screening and Visit 15
Description
Including Glucose, uric acid, urea, calcium, creatinine, total protein, phosphorus, cholesterol, albumin and total bilirubin concentration
Time Frame
6 months approximately
Title
Changes in serum chemistry values between screening and Visit 15
Description
Including alkaline phosphatase, LDH, AST, ALT, GGT, CRP.
Time Frame
6 months approximately
Title
Changes in haematology values between screening and Visit 15 - RBC, WBC, Platelets
Description
Including total WBC and differentials, total RBC, RBC indices and platelet count.
Time Frame
6 months approximately
Title
Changes in haematology values between screening and Visit 15 - Haemoglobin
Description
Haemoglobin concentration
Time Frame
6 months approximately
Title
Changes in clinical laboratory values (urinalysis) between screening and Visit 15
Description
Urinalysis (using a urine dip-stick) pH, protein, glucose, ketones, bilirubin, blood, nitrite, urobilinogen, leukocytes. Note: Microscopic examination will be conducted if protein, leukocytes, nitrite, and/or blood are detected. If needed, microscopic examination will include WBC, RBC, casts, and bacteria.
Time Frame
6 months approximately
Title
Changes in vital signs (all subjects) at all treatment visits - Blood pressure
Description
systolic and diastolic blood pressure
Time Frame
7 months approximately
Title
Changes in vital signs (all subjects) at all treatment visits - Pulse rate
Time Frame
7 months approximately
Title
Changes in vital signs (all subjects) at all treatment visits - Respiratory rate
Time Frame
7 months approximately
Title
Changes in vital signs (all subjects) at all treatment visits - Body temperature
Time Frame
7 months approximately
Title
Changes in PEFR (only in subjects with past or current asthma) at all treatment visits
Description
PEFR - peak expiratory flow rate
Time Frame
7 months approximately

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: - 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: 18 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. Subjects who have no suspicion or symptoms of SARS-CoV-2 infection (as assessed by the investigator) or who have had no contact with a confirmed case of COVID-19 in the past 2 weeks prior to screening and randomisation. Exclusion Criteria (include amongst others): - 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. Clinical history of Type I diabetes. Subjects with well-controlled Type II diabetes will be allowed to participate at the discretion of the investigator. Any acute infection (including upper respiratory tract infections in the 14 days prior to Visit 2), which in the opinion of the investigator may pose a safety risk to the subject. Clinical history of severe or serious systemic reaction in response to AIT treatment 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 IMP. Tyrosine metabolism disorders, especially tyrosinemia and alkaptonuria. - Prior/concomitant therapy: History of any allergen SIT. Inability to adhere to the washout periods for Prohibited Medications/Therapies with respect to Visit 1/1a and to refrain from using the medications indicated until after Visit 15. Treatment with a preparation containing MPL (e.g., Cervarix, Shingrix, Fendrix) within 2 years prior to Visit 1 and until after completion of Visit 15 (with the exception of the IMP). 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 sympathomimetic). Previous history of epinephrine device use. β-blocker medication (including eye drops), for any indication. Monoamine oxidase inhibitors and tricyclic antidepressants. (Tricyclic antidepressants should be avoided at least 2 weeks prior to screening). Any previous therapy (within 12 months prior to screening) or current therapy with anti IgE (e.g., Xolair) or anti-interleukins (e.g., mepolizumab) or any other therapy with a biologic agent. Unable to refrain from any vaccination (including influenza and any potential vaccine for COVID-19) during the study (unless administered more than 30 days prior to randomisation). Please note: Emergency vaccinations (e.g., tetanus due to injury) can be administered at any time. Current or past therapy (within the previous 5 years) with immunosuppressant drugs or immunomodulatory biologics. Other exclusions Clinical history of drug or alcohol abuse which, in the investigator's opinion, could interfere with the subject's ability to participate in the study. Participation in a clinical research trial with any IMP within 4 weeks of Visit 1 or concomitantly with this study Personal, financial or other dependent relationship (e.g., employee or immediate relative) with the study site, Sponsor, Sponsor's representative, or another individual who has access to the study 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 22 days or more in similar or mixed geographic regions as determined by the investigator, with no single trip in a similar geographical region exceeding 14 days and no single trip in a non-similar geographical region exceeding 7 days, Absence of 15 days or more in non-similar geographic regions as determined by the investigator, with no single trip exceeding 7 days. Have changed residence between geographical regions since the last GPS. Exception: the old and new residences are in the same or similar geographical region as determined by the investigator.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pieter-Jan de Kam, Ph.D
Organizational Affiliation
Clinical Director
Official's Role
Study Director
Facility Information:
Facility Name
Allergy and Asthma Associates of Bluegrass
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40509
Country
United States
Facility Name
Chesapeake Clinical Research, Inc.
City
White Marsh
State/Province
Maryland
ZIP/Postal Code
21236
Country
United States
Facility Name
Atlantic Research Center, LLC
City
Ocean Township
State/Province
New Jersey
ZIP/Postal Code
07712
Country
United States
Facility Name
Smith Allergy & Asthma Specialists
City
Cortland
State/Province
New York
ZIP/Postal Code
13045
Country
United States
Facility Name
Corning Center for Clinical Research
City
Horseheads
State/Province
New York
ZIP/Postal Code
14845
Country
United States
Facility Name
Allergy Partners of Western North Carolina
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
Facility Name
Bernstein Clinical Research Center, LLC
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45231
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
Universitatsmedizin Berlin - Charite Campus Mitte - Allergie Centrum Charite
City
Berlin
Country
Germany
Facility Name
Universitätsklinikum Carl Gustav Carus an der TU Dresden
City
Dresden
Country
Germany
Facility Name
ENT RESEARCH - Institut für klinische Studien
City
Essen
Country
Germany
Facility Name
Medaimun GmbH
City
Frankfurt am Main
Country
Germany
Facility Name
Hamburger Institut für Therapieforschung GmbH
City
Hamburg
Country
Germany
Facility Name
Studienzentrum Dr. Sabine Laßmann
City
Saalfeld
Country
Germany

12. IPD Sharing Statement

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An Exploratory Study of PQ Grass 27600 SU

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