Ignite Creation Date:
2025-12-24 @ 2:45 PM
Ignite Modification Date:
2025-12-25 @ 9:19 PM
Study NCT ID:
NCT04687059
Status:
COMPLETED
Last Update Posted:
2022-01-19
First Post:
2020-10-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Exploratory Study of PQ Grass 27600 SU
Sponsor:
Allergy Therapeutics
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2021-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2020-000408-13 | EUDRACT_NUMBER | None | View |