Clinical Trial Results:
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
Summary
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EudraCT number |
2019-001517-16 |
Trial protocol |
DE HU CZ AT PL |
Global end of trial date |
01 Nov 2023
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Results information
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Results version number |
v1(current) |
This version publication date |
16 Nov 2024
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First version publication date |
16 Nov 2024
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
PQGrass306
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT05540717 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Allergy Therapeutics (UK) Ltd.
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Sponsor organisation address |
Dominion Way, Worthing BN14 8SA, West Sussex, United Kingdom,
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Public contact |
Clinical Research Management, Bencard Allergie GmbH, pqgrass306@allergytherapeutics.com
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Scientific contact |
Clinical Research Management, Bencard Allergie GmbH, pqgrass306@allergytherapeutics.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
15 Dec 2023
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
01 Nov 2023
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Global end of trial reached? |
Yes
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Global end of trial date |
01 Nov 2023
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Was the trial ended prematurely? |
No
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General information about the trial
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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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Protection of trial subjects |
The risk of anaphylaxis was mitigated by carefully selecting sites with trained personnel and specific equipment to manage anaphylaxis, by excluding high-risk participants and by providing specific instructions to participants in order to minimise the risk.
An independent Adjudication Committee was installed to evaluate any important safety information.
A Trial Oversight Committee with regular meetings was installed to oversee the safety of the participants during the conduct of the study.
Participants were monitored from the time of ICF signature throughout the study for the detection of exacerbations of pre-existing allergy symptoms.
The use of placebo was mitigated by providing subjects with relief medication during the grass pollen season and by extensive safety monitoring.
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Background therapy |
Participants were provided relief medication including oral and ocular antihistamine, and nasal and oral coricosteroids. | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
22 Aug 2022
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Poland: 153
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Country: Number of subjects enrolled |
Austria: 25
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Country: Number of subjects enrolled |
Czechia: 67
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Country: Number of subjects enrolled |
Germany: 242
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Country: Number of subjects enrolled |
Hungary: 1
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Country: Number of subjects enrolled |
United States: 67
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Worldwide total number of subjects |
555
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EEA total number of subjects |
488
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
555
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
The clinical trial was conducted at 89 sites (65 in Europe and 24 in the United States) and overall, 555 subjects were randomised and included in the FAS and the SAF. There was a near equal assignment of subjects to PQ Grass and placebo. One subject randomised to placebo received PQ Grass therefore, 279 subjects were treated with PQ Grass. | ||||||||||||||||||||||||||||||
Pre-assignment
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Screening details |
Male or female aged 18 to 65 years with a positive history of moderate to severe seasonal allergic rhinoconjunctivitis ascribed to grass pollen exposure requiring treatment for at least two consecutive seasons prior to study. | ||||||||||||||||||||||||||||||
Period 1
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Period 1 title |
Period 1 (Screening)
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Is this the baseline period? |
Yes | ||||||||||||||||||||||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||||||||||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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PQ Grass 27600 SU | ||||||||||||||||||||||||||||||
Arm description |
6 pre-seasonal injections of active treatment (900, 2700, 6000, 6000, 6000 and 6000 SU sequentially) to achieve a cumulative nominal dose of 27600 SU | ||||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||||
Investigational medicinal product name |
PQ Grass
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Suspension for injection
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
6 injections of active treatment (900, 2700, 6000, 6000, 6000 and 6000 SU sequentially) to achieve a cumulative nominal dose of 27600 SU
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Arm title
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Placebo | ||||||||||||||||||||||||||||||
Arm description |
6 pre-seasonal injections of placebo | ||||||||||||||||||||||||||||||
Arm type |
Placebo | ||||||||||||||||||||||||||||||
Investigational medicinal product name |
Placebo
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for injection in vial
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
6 doses of placebo
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Period 2
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Period 2 title |
Period 2 (randomisation and treatment)
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Is this the baseline period? |
No | ||||||||||||||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | ||||||||||||||||||||||||||||||
Roles blinded |
Subject, Investigator, Monitor, Data analyst, Carer | ||||||||||||||||||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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PQ Grass 27600 SU | ||||||||||||||||||||||||||||||
Arm description |
6 pre-seasonal injections of active treatment (900, 2700, 6000, 6000, 6000 and 6000 SU sequentially) to achieve a cumulative nominal dose of 27600 SU | ||||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||||
Investigational medicinal product name |
PQ Grass
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Suspension for injection
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
6 injections of active treatment (900, 2700, 6000, 6000, 6000 and 6000 SU sequentially) to achieve a cumulative nominal dose of 27600 SU
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Arm title
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Placebo | ||||||||||||||||||||||||||||||
Arm description |
6 pre-seasonal injections of placebo | ||||||||||||||||||||||||||||||
Arm type |
Placebo | ||||||||||||||||||||||||||||||
Investigational medicinal product name |
Placebo
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
6 injections of placebo
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Baseline characteristics reporting groups
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Reporting group title |
PQ Grass 27600 SU
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Reporting group description |
6 pre-seasonal injections of active treatment (900, 2700, 6000, 6000, 6000 and 6000 SU sequentially) to achieve a cumulative nominal dose of 27600 SU | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Placebo
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Reporting group description |
6 pre-seasonal injections of placebo | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
PQ Grass 27600 SU
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Reporting group description |
6 pre-seasonal injections of active treatment (900, 2700, 6000, 6000, 6000 and 6000 SU sequentially) to achieve a cumulative nominal dose of 27600 SU | ||
Reporting group title |
Placebo
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Reporting group description |
6 pre-seasonal injections of placebo | ||
Reporting group title |
PQ Grass 27600 SU
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Reporting group description |
6 pre-seasonal injections of active treatment (900, 2700, 6000, 6000, 6000 and 6000 SU sequentially) to achieve a cumulative nominal dose of 27600 SU | ||
Reporting group title |
Placebo
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Reporting group description |
6 pre-seasonal injections of placebo |
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End point title |
Combined symptom and medication score Averaged Over Peak GPS | ||||||||||||
End point description |
The combined symptom and medication score was calculated as an average score during the Grass pollen season (GPS).
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End point type |
Primary
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End point timeframe |
The combined symptom and medication score was was recorded during the peak GPS. The peak GPS timeframe was dependent on each geographical region with an average of approximately 3-4 weeks
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Notes [1] - The analysis of CSMS is reported on the full analysis set. See justification [2] - The analysis of CSMS is reported on the full analysis set, see justification |
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Statistical analysis title |
Comparison of CSMS averaged over the peak GPS | ||||||||||||
Comparison groups |
PQ Grass 27600 SU v Placebo
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Number of subjects included in analysis |
555
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Analysis specification |
Post-hoc
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Analysis type |
superiority [3] | ||||||||||||
P-value |
= 0.00048 | ||||||||||||
Method |
Mixed models analysis | ||||||||||||
Parameter type |
relative difference (%) | ||||||||||||
Point estimate |
-20.25
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
-31 | ||||||||||||
upper limit |
-9.49 | ||||||||||||
Notes [3] - Linear mixed model using treatment group as fixed effect and pooled geographical region as random effect |
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End point title |
CSMS averaged over the entire (or truncated) GPS | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
The CSMS was recorded during the entire GPS. The entire GPS depends on the pollen counts, which differs across geographical regions, but usually lasts approximately 13-14 weeks.
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Statistical analysis title |
Comparison of CSMS averaged over the entire GPS | ||||||||||||
Comparison groups |
PQ Grass 27600 SU v Placebo
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Number of subjects included in analysis |
533
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Analysis specification |
Pre-specified
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Analysis type |
superiority [4] | ||||||||||||
P-value |
= 0.00032 | ||||||||||||
Method |
Mixed models analysis | ||||||||||||
Parameter type |
relative difference (%) | ||||||||||||
Point estimate |
-20.2
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
-30.13 | ||||||||||||
upper limit |
-10.27 | ||||||||||||
Notes [4] - Linear mixed model using treatment group as fixed effect and pooled geographical region as random effect |
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End point title |
dSS component of the CSMS averaged over the peak GPS | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
The dSS component of the CSMS was recorded during the peak GPS. The peak GPS depends on the pollen counts, which differs across geographical regions, but usually lasts approximately 3-4 weeks.
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Statistical analysis title |
Comparison of dSS of CSMS on peak GPS | ||||||||||||
Comparison groups |
PQ Grass 27600 SU v Placebo
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Number of subjects included in analysis |
531
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Analysis specification |
Pre-specified
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Analysis type |
superiority [5] | ||||||||||||
P-value |
= 0.00223 | ||||||||||||
Method |
Mixed models analysis | ||||||||||||
Parameter type |
relative difference (%) | ||||||||||||
Point estimate |
-16.35
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
-26.27 | ||||||||||||
upper limit |
-6.44 | ||||||||||||
Notes [5] - Linear mixed model using treatment group as fixed effect and pooled geographical region as random effect |
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End point title |
dSS component of the CSMS averaged over the entire GPS | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
The dSS component of the CSMS was recorded during the entire GPS. The peak GPS depends on the pollen counts, which differs across geographical regions, but usually lasts approximately 13-14 weeks.
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Statistical analysis title |
Comparison of dSS of CSMS on entire GPS | ||||||||||||
Comparison groups |
PQ Grass 27600 SU v Placebo
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Number of subjects included in analysis |
533
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Analysis specification |
Pre-specified
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Analysis type |
superiority [6] | ||||||||||||
P-value |
= 0.00076 | ||||||||||||
Method |
Mixed models analysis | ||||||||||||
Parameter type |
relative difference (%) | ||||||||||||
Point estimate |
-16.58
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
-25.66 | ||||||||||||
upper limit |
-7.5 | ||||||||||||
Notes [6] - Linear mixed model using treatment group as fixed effect and pooled geographical region as random effect |
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End point title |
dMS component of the CSMS averaged over the peak GPS | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
The dMS component of the CSMS was recorded during the peak GPS. The peak GPS depends on the pollen counts, which differs across geographical regions, but usually lasts approximately 3-4 weeks.
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Statistical analysis title |
Comparison of dMS of CSMS on peak GPS | ||||||||||||
Comparison groups |
PQ Grass 27600 SU v Placebo
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Number of subjects included in analysis |
531
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Analysis specification |
Pre-specified
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Analysis type |
superiority [7] | ||||||||||||
P-value |
= 0.0008 | ||||||||||||
Method |
Mixed models analysis | ||||||||||||
Parameter type |
relative difference (%) | ||||||||||||
Point estimate |
-26.54
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
-41.15 | ||||||||||||
upper limit |
-11.94 | ||||||||||||
Notes [7] - Linear mixed model using treatment group as fixed effect and pooled geographical region as random effect |
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End point title |
dMS component of the CSMS averaged over the entire GPS | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
The dMS component of the CSMS was recorded during the entire GPS. The peak GPS depends on the pollen counts, which differs across geographical regions, but usually lasts approximately 13-14 weeks.
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Statistical analysis title |
Comparison of dMS of CSMS on entire GPS | ||||||||||||
Comparison groups |
PQ Grass 27600 SU v Placebo
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Number of subjects included in analysis |
533
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Analysis specification |
Pre-specified
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Analysis type |
superiority [8] | ||||||||||||
P-value |
= 0.00031 | ||||||||||||
Method |
Mixed models analysis | ||||||||||||
Parameter type |
relative difference (%) | ||||||||||||
Point estimate |
-26.6
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
-40.49 | ||||||||||||
upper limit |
-12.72 | ||||||||||||
Notes [8] - Linear mixed model using treatment group as fixed effect and pooled geographical region as random effect. |
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End point title |
Number of well days during peak GPS | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
The number of well days was recorded during the peak GPS. The peak GPS depends on the pollen counts, which differs across geographical regions, but usually lasts approximately 3-4 weeks.
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Statistical analysis title |
Probability of well days during peak GPS | ||||||||||||
Comparison groups |
PQ Grass 27600 SU v Placebo
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Number of subjects included in analysis |
531
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
= 0.10846 [9] | ||||||||||||
Method |
Regression, Logistic | ||||||||||||
Parameter type |
Odds ratio (OR) | ||||||||||||
Point estimate |
1.254
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
0.951 | ||||||||||||
upper limit |
1.652 | ||||||||||||
Notes [9] - GEE model for binary response with treatment as fixed effect, pooled geographical region and grass pollen count per day as covariates, and assuming a within-subject working correlation. |
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End point title |
RQLQ(S) measured within the peak GPS | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Rhinoconjunctivitis Quality of Life Questionnaire with standardised activities (RQLQ) was recorded during the peak GPS. The peak GPS depends on the pollen counts, which differs across geographical regions, but usually lasts approximately 3-4 weeks.
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Statistical analysis title |
Comparison of average total RQLQ | ||||||||||||
Comparison groups |
PQ Grass 27600 SU v Placebo
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Number of subjects included in analysis |
340
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Analysis specification |
Pre-specified
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Analysis type |
superiority [10] | ||||||||||||
P-value |
= 0.00009 | ||||||||||||
Method |
Mixed models analysis | ||||||||||||
Parameter type |
Mean difference (final values) | ||||||||||||
Point estimate |
-0.49
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
-0.73 | ||||||||||||
upper limit |
-0.25 | ||||||||||||
Notes [10] - Linear mixed model using treatment group as fixed effect, Baseline total RQLQ score as covariate and pooled geographical region as random effect |
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End point title |
Serum grass specific IgG4 at Baseline and Visit 7 | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Measurement of grass-specific IgG4 was performed at baseline and visit 7.
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Statistical analysis title |
Change of serum grass-specific IgG4 levels | ||||||||||||
Comparison groups |
PQ Grass 27600 SU v Placebo
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Number of subjects included in analysis |
472
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Analysis specification |
Pre-specified
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Analysis type |
superiority [11] | ||||||||||||
P-value |
< 0.00001 | ||||||||||||
Method |
Mixed models analysis | ||||||||||||
Parameter type |
Median difference (final values) | ||||||||||||
Point estimate |
3.99
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
3.28 | ||||||||||||
upper limit |
4.7 | ||||||||||||
Notes [11] - Linear mixed model using treatment group as fixed effect, Baseline serum grass-specific IgG4 [mg/L] as a covariate and pooled geographical region as random effect |
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End point title |
Frequency, severity and relationship of AEs to treatment | |||||||||||||||||||||||||||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Adverse events were reported from baseline to the last follow-up visit.
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Notes [12] - The AEs are reported on the number of subjects receiving the active treatment (n=279) [13] - The number of AEs are reported on the subjects receiving placebo (n=276) |
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No statistical analyses for this end point |
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Adverse events information
|
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Timeframe for reporting adverse events |
AE reporting was performed throughout the study, which had an overall duration of 387 days.
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Adverse event reporting additional description |
One subject randomised to placebo received PQ Grass throughout the trial, consequently 279 subjects were treated with PQ Grass and 276 subjects with placebo; results are based on treatment received.
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
26
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Reporting groups
|
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Reporting group title |
PQ Grass 27600 SU
|
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Reporting group description |
injections of active treatment (900, 2700, 6000, 6000, 6000 and 6000 SU sequentially) to achieve a cumulative nominal dose of 27600 SU | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Placebo
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Reporting group description |
6 injections of placebo | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
||
10 Nov 2022 |
Version 3.0_Global was created to harmonize the protocol so that all the updates included in the different versions of the protocol (as stipulated in the tables below) that are currently in use in the
different regions can be in one global version. Furthermore, additional updates were made to the Version 3.0_Global clinical trial protocol as indicated in the table below. Administrative edits were
also made as needed all through the document. |
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20 Jun 2023 |
Version 4.0_Global was created to incorporate an interim analysis in the ongoing clinical trial and to provide the option of a second season (Year 2) for the clinical trial if needed as it was not
possible to recruit the initially planned number of subjects within one year (Year 1). The amendment includes a description of the changes if a second season will become part of the trial,
and it describes the process for an interim analysis that is planned to be performed based on Year 1 data. Administrative edits were also made as needed all through the document. |
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Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |