Ignite Creation Date:
2024-05-06 @ 4:06 PM
Last Modification Date:
2024-10-26 @ 2:04 PM
Study NCT ID:
NCT04878354
Status:
COMPLETED
Last Update Posted:
2023-08-02
First Post:
2021-03-24
Brief Title:
A Study in Children and Adolescents With Birch Pollen-induced Rhinoconjunctivitis
Sponsor:
ALK-Abelló AS
Organization:
ALK-Abelló AS
Study Overview
Official Title:
Efficacy and Safety of the SQ Tree Sublingual Immunotherapy Tablet in Children and Adolescents With Moderate to Severe Allergic Rhinitis andor Conjunctivitis Induced by Pollen From Birch and Trees Belonging to the Birch Homologous Group
Status:
COMPLETED
Status Verified Date:
2023-08
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:
TreeTop
Brief Summary:
This is a clinical study in children and adolescents 5-17 years with allergy to pollen from birch or related trees It compares the tree SLIT-tablet with placebo in relieving rhinoconjunctivitis symptoms during the birchtree pollen season based on the average allergic rhinoconjunctivitis daily total combined score
The study will also collect health-related quality of life information in the groups treated with the tree SLIT-tablet or with placebo during the pollen season
The trial medication used is already approved to treat allergic rhinitis caused by birchtree pollen in adults in several countries
The study will also collect health-related quality of life information in the groups treated with the tree SLIT-tablet or with placebo during the pollen season
The trial medication used is already approved to treat allergic rhinitis caused by birchtree pollen in adults in several countries
Detailed Description:
This is a phase III parallel-group double-blind placebo-controlled study to evaluate efficacy and safety of the tree SLIT-tablet in children and adolescents 5-17 years who have rhinoconjunctivitis with or without asthma induced by pollen from birch trees or by trees belonging to the birch homologous group Approximately 1000 children and adolescents will be enrolled in the trial and will receive either the tree SLIT-tablet or placebo
The trial consists of 3 periods a screening period a treatment period which includes pre-seasonal and co seasonal treatment and a follow-up period The duration is up to 13 months for each participant
The trial is conducted in several European countries and in Canada
The trial consists of 3 periods a screening period a treatment period which includes pre-seasonal and co seasonal treatment and a follow-up period The duration is up to 13 months for each participant
The trial is conducted in several European countries and in Canada
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2020-004372-17 | EUDRACT_NUMBER | None | None |