Ignite Creation Date:
2025-12-25 @ 12:46 AM
Ignite Modification Date:
2026-03-09 @ 9:20 PM
Study NCT ID:
NCT03101267
Status:
COMPLETED
Last Update Posted:
2024-11-26
First Post:
2017-04-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Dose-finding Study of ASP4070
Sponsor:
Astellas Pharma Inc
Organization:
Study Overview
Official Title:
Phase 2 Dose-finding Study of ASP4070 - A Randomized, Double-blind, Placebo-controlled, Dose-finding Study in Patients With Cedar Pollinosis Using an Environmental Exposure Chamber -
Status:
COMPLETED
Status Verified Date:
2024-11
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 objective of this study was to evaluate the efficacy, safety, and dose-response of ASP4070 vaccinated in patients with cedar pollinosis.
Detailed Description:
Subjects were vaccinated with ASP4070 or placebo at 2 week intervals. Clinical symptoms were evaluated after cedar pollen exposure in a chamber at 4, 8 and 12 weeks after the last vaccination to identify the timing of the onset of therapeutic effect.
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?:
True
Is an FDA AA801 Violation?: