Ignite Creation Date:
2024-05-06 @ 6:26 PM
Last Modification Date:
2024-10-26 @ 2:48 PM
Study NCT ID:
NCT05668390
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-18
First Post:
2022-11-17
Brief Title:
Safety and Efficacy of STALORAL Birch 300 IR in a Paediatric Population With Birch Pollen-induced ARC wo Asthma
Sponsor:
Stallergenes Greer
Organization:
Stallergenes Greer
Study Overview
Official Title:
A Multi-national Phase IIIb Double-blind Placebo-controlled Trial to Determine the Safety and Efficacy of STALORAL Birch 300 IR in Children and Adolescents 5 to 17 yo With Birch Pollen-induced Allergic Rhinoconjunctivitis wo Asthma
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-07
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:
YOBI
Brief Summary:
Allergic rhinoconjunctivitis due to birch pollen is a seasonal problem which manifests as a combination of nasal symptoms such as congestion runny nose sneezing itching of the nose and ocular symptoms such as red itchy and watery eyes For several birch-allergic patients allergic rhinoconjunctivitis occurs with an oral allergy syndrome
The purpose of this study is to demonstrate the safety and efficacy of the study drug STALORAL Birch 300 IR in children and adolescents with birch pollen-induced allergic rhinoconjunctivitis with or without asthma when treated before and during the pollen season
Approximately 699 children will participate in this study The study will be conducted worldwide in approximately 80 medical sites in about 12 countries The total duration of the study will be approximately 20 months
The purpose of this study is to demonstrate the safety and efficacy of the study drug STALORAL Birch 300 IR in children and adolescents with birch pollen-induced allergic rhinoconjunctivitis with or without asthma when treated before and during the pollen season
Approximately 699 children will participate in this study The study will be conducted worldwide in approximately 80 medical sites in about 12 countries The total duration of the study will be approximately 20 months
Detailed Description:
Birch pollen is a major cause of allergic rhinitisallergic rhino-conjunctivitis in Europe and worldwide with up to 100 million reported cases Allergic rhinitisallergic rhino-conjunctivitis ARARC is a chronic disorder of the upper airways that is caused by allergen exposure and the resulting inflammation of the nose and to a less extent the eyes allergic rhino-conjunctivitis Rhinitis symptoms include sneezing runny nose nasal itching and nasal congestion and can be associated with conjunctivitis symptoms such as watery red andor itchy eyes Current treatment are allergen avoidance symptomatic pharmacotherapy and Allergen Immunotherapy AIT However avoidance measures are generally not effective While symptomatic treatment can provide temporary relief from allergy symptoms many patients remain uncontrolled
The goal of this study is to demonstrate the clinical efficacy of an allergen immunotherapy STALORAL Birch 300 IR in children and adolescents from 5 to 17 years old with birch pollen-induced allergic rhinoconjunctivitis treated once daily pre- and co-seasonally over two consecutive birch pollen seasons on the average daily ARC Total Combined Score TCS during the season
This study is a multi-national phase IIIb double-blind placebo-controlled study in which 699 participants will be enrolled in Europe for 20 months during two consecutive seasons
Participants will begin STALORAL Birch 300 IR administration 35 months to 45 months prior to the birch pollen season pre-seasonal treatment and continue taking it for the duration of the season co-seasonal treatment There will approximately be 5 months of a treatment-free period prior to the next 35-month to 4-month pre-seasonal treatment period and co-seasonal treatment
The analysis will be performed at the end of the Year 2
The goal of this study is to demonstrate the clinical efficacy of an allergen immunotherapy STALORAL Birch 300 IR in children and adolescents from 5 to 17 years old with birch pollen-induced allergic rhinoconjunctivitis treated once daily pre- and co-seasonally over two consecutive birch pollen seasons on the average daily ARC Total Combined Score TCS during the season
This study is a multi-national phase IIIb double-blind placebo-controlled study in which 699 participants will be enrolled in Europe for 20 months during two consecutive seasons
Participants will begin STALORAL Birch 300 IR administration 35 months to 45 months prior to the birch pollen season pre-seasonal treatment and continue taking it for the duration of the season co-seasonal treatment There will approximately be 5 months of a treatment-free period prior to the next 35-month to 4-month pre-seasonal treatment period and co-seasonal treatment
The analysis will be performed at the end of the Year 2
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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?:
None