Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2025-12-25 @ 8:53 PM
Study NCT ID:
NCT02481856
Status:
COMPLETED
Last Update Posted:
2017-01-19
First Post:
2015-04-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Dose-response Evaluation of the SQ Tree SLIT-tablet Using an Environmental Exposure Chamber
Sponsor:
ALK-Abelló A/S
Organization:
Study Overview
Official Title:
A Dose-response Evaluation of the SQ Tree SLIT-tablet in Subjects With Moderate to Severe Allergic Rhinoconjunctivitis Induced by Pollens From the Birch Group During Controlled Exposure in an Environmental Exposure Chamber
Status:
COMPLETED
Status Verified Date:
2017-01
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:
The trial is a phase II, randomised, parallel-group, double-blind, placebo-controlled multi-site trial conducted in Canada. Before the start of treatment, the subjects will undergo baseline birch and oak Environmental Exposure Chamber sessions. The treatment duration is 24 weeks. The subjects will undergo birch Environmental Exposure Chamber sessions after 8, 16 and 24 weeks of treatment and an oak Environmental Exposure Chamber session after 24 weeks of treatment.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: