Randomised efficacy and safety clinical trial of PQ Grass in subjects with seasonal allergic rhinitis and/or rhinoconjunctivitis induced by grass polle

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 1342

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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1142
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 200

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

Updated 1/13/2015

Randomised efficacy and safety clinical trial of PQ Grass in subjects with seasonal allergic rhinitis and/or rhinoconjunctivitis induced by grass polle

Recruitment & Eligibility

Study & Design

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