| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Seasonal allergic rhinitis and/or rhinoconjunctivitis induced by grass pollen exposure |
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| E.1.1.1 | Medical condition in easily understood language |
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| E.1.1.2 | Therapeutic area | Body processes [G] - Immune system processes [G12] |
| MedDRA Classification |
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 20.0 |
| E.1.2 | Level | LLT |
| E.1.2 | Classification code | 10001728 |
| E.1.2 | Term | Allergic rhinoconjunctivitis |
| E.1.2 | System Organ Class | 100000004853 |
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| E.1.3 | Condition being studied is a rare disease | No |
| E.2 Objective of the trial |
| E.2.1 | Main objective of the trial |
Efficacy: To evaluate the efficacy of PQ Grass 27600 SU in subjects with grass pollen induced SAR and/or rhinoconjunctivitis based on symptoms and medications.
Safety: To evaluate the safety and tolerability of PQ Grass in subjects with grass pollen induced SAR and/or rhinoconjunctivitis.
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| E.2.2 | Secondary objectives of the trial |
To evaluate the potential of PQ Grass 27600 SU to reduce symptom burden and the need for medication use.
To evaluate the quality of life.
To evaluate the effect of PQ Grass 27600 SU on IgG4.
To evaluate the treatment effect of PQ Grass on the CSMS over the entire GPS
To evaluate the treatment effect of PQ Grass on the dSS and dMS components of the CSMS over the GPS
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| E.2.3 | Trial contains a sub-study | Yes |
| E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
| Biomarker study as described in protocol. To evaluate changes in nasal, serum and/or functional and/or cell-based biomarkers in a subset of subjects at selected clinical trial sites in Germany, and to explore their relationship to the clinical outcome. |
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| E.3 | Principal inclusion criteria |
1. Capable of giving signed informed consent
2. Subject who has signed and dated the ICF.
3. Subject must be 18 to 65 years of age inclusive, at the time of signing the ICF.
4. Male or female.
5. For female subjects only: female subjects who are not of childbearing potential or females of childbearing potential who agree to comply with the contraceptive requirements of the study protocol
6. Positive history of moderate to severe symptoms of seasonal allergic rhinitis and/or rhinoconjunctivitis ascribed to grass pollen exposure of at least 2 seasons duration.
For Detailed list see the protocol
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| E.4 | Principal exclusion criteria |
1. Pregnant or lactating subject.
2. Presence of any medical history of moderate to severe allergy symptoms (verified by a positive SPT or positive specific IgE [≥2]* at screening) to any other seasonal allergen (other than grass) or perennial allergens.
*Please note: The specific IgE testing mentioned above is applicable only in Europe for Cockroach and Ash allergens. Class ≥2 by an ImmunoCAP test implies specific IgE ≥0.71 kUA/ L. Furthermore, in Europe if SPTs are not available in Year 2 of the trial (as detailed in Section 10.10, Appendix 10 of the protocol), all the listed allergens [apart from the 12-grass mix] for the European panel will be tested using specific IgE measurements for same or similar allergens; i.e., Class ≥2 by an ImmunoCAP test.
3. Subjects with a positive SPT at US 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 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.
Please note: In countries in Europe where Johnson grass or Bahia grass is present, any medical history of moderate to severe symptoms to Johnson grass and/or Bahia grass will represent a reason for exclusion as it will not be possible to conduct Period 1, Period 2 and Period 3 of the entire clinical trial outside of their pollen seasons. Albeit Johnson grass and Bahia grass are being commonly defined as grasses, they belong to the Poaceae family.
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 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:
a. Severe asthma (as per the current GINA guidelines [GINA, 2022]).
b. Uncontrolled or poorly controlled asthma as per the current GINA guidelines (GINA, 2022).
c. 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).
d. 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.
e. Prior intubation/mechanical ventilation for asthma.
f. Emergency room visit or hospitalisation for asthma in the 12 months prior to screening or Visit 2.
g. Any history of a life-threatening asthma attack.
h. FEV1 <70% of predicted or FEV1/FVC ≤75% or PEFR <70% of predicted with or without controller medications at screening or Visit 2.
For Detailed List see the Protocol
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| E.5 End points |
| E.5.1 | Primary end point(s) |
Efficacy: CSMS averaged over the peak GPS
Safety: Frequency, severity and relationship of AEs to treatment.
Frequency of AEs leading to premature discontinuation from treatment or clinical trial.
Frequency of AESI.
Changes in clinical laboratory values (serum chemistry, haematology and urinalysis) between screening and Visit 11.
Changes in vital signs at all treatment visits
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| E.5.1.1 | Timepoint(s) of evaluation of this end point |
| daily / during the GPS / during the course of the study as indicated in the protocol |
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| E.5.2 | Secondary end point(s) |
Efficacy: The number of well days during the peak GPS.
RQLQ(S) measured within the peak GPS.
Serum grass specific IgG4 at Visit 7 compared to baseline.
CSMS averaged over the entire (or truncated) GPS.
dSS component of the CSMS averaged over the peak GPS and entire (or truncated) GPS.
dMS component of the CSMS averaged over the peak GPS and entire (or truncated) GPS.
Safety: Frequency, severity and relationship of AEs to treatment.
Frequency of AEs leading to premature discontinuation from treatment or clinical trial.
Frequency of AESI.
Changes in clinical laboratory values (serum chemistry, haematology and
urinalysis) between screening and Visit 11.
Changes in vital signs at all treatment visits
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| E.5.2.1 | Timepoint(s) of evaluation of this end point |
| daily / during the GPS / during the course of the study as indicated in the protocol |
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| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | No |
| E.6.2 | Prophylaxis | No |
| E.6.3 | Therapy | Yes |
| E.6.4 | Safety | Yes |
| E.6.5 | Efficacy | Yes |
| E.6.6 | Pharmacokinetic | No |
| E.6.7 | Pharmacodynamic | Yes |
| E.6.8 | Bioequivalence | No |
| E.6.9 | Dose response | No |
| E.6.10 | Pharmacogenetic | No |
| E.6.11 | Pharmacogenomic | Yes |
| E.6.12 | Pharmacoeconomic | No |
| E.6.13 | Others | No |
| E.7 | Trial type and phase |
| E.7.1 | Human pharmacology (Phase I) | No |
| E.7.1.1 | First administration to humans | No |
| E.7.1.2 | Bioequivalence study | No |
| E.7.1.3 | Other | No |
| E.7.1.3.1 | Other trial type description | |
| E.7.2 | Therapeutic exploratory (Phase II) | No |
| E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
| E.7.4 | Therapeutic use (Phase IV) | No |
| E.8 Design of the trial |
| E.8.1 | Controlled | Yes |
| E.8.1.1 | Randomised | Yes |
| E.8.1.2 | Open | No |
| E.8.1.3 | Single blind | No |
| E.8.1.4 | Double blind | Yes |
| E.8.1.5 | Parallel group | Yes |
| E.8.1.6 | Cross over | No |
| E.8.1.7 | Other | No |
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | No |
| E.8.2.2 | Placebo | Yes |
| E.8.2.3 | Other | No |
| E.8.2.4 | Number of treatment arms in the trial | 2 |
| E.8.3 |
The trial involves single site in the Member State concerned
| No |
| E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
| E.8.4.1 | Number of sites anticipated in Member State concerned | 29 |
| E.8.5 | The trial involves multiple Member States | Yes |
| E.8.5.1 | Number of sites anticipated in the EEA | 51 |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
| E.8.6.2 | Trial being conducted completely outside of the EEA | No |
| E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
| United States |
| Austria |
| Czechia |
| Germany |
| Hungary |
| Poland |
|
| E.8.7 | Trial has a data monitoring committee | Yes |
| E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
| The End of the study is defined as the date of last 6 months telephone follow up call of the last subject in the study. |
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| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | 2 |
| E.8.9.1 | In the Member State concerned months | 1 |
| E.8.9.1 | In the Member State concerned days | |
| E.8.9.2 | In all countries concerned by the trial years | 2 |
| E.8.9.2 | In all countries concerned by the trial months | 1 |
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