Ignite Creation Date:
2024-05-05 @ 7:19 PM
Last Modification Date:
2024-10-26 @ 9:46 AM
Study NCT ID:
NCT00640016
Status:
TERMINATED
Last Update Posted:
2017-01-31
First Post:
2008-03-13
Brief Title:
A Study to Assess the Efficacy Safety and Tolerability of CAT-354 in Subjects With Asthma
Sponsor:
MedImmune LLC
Organization:
MedImmune LLC
Study Overview
Official Title:
A Double-Blind Placebo-Controlled Parallel-Group Study to Assess the Efficacy Safety and Tolerability of CAT-354
Status:
TERMINATED
Status Verified Date:
2016-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was terminated prematurely by the sponsor due to slow recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To investigate the effects of CAT-354 on airway hyper-responsiveness AHR in uncontrolled asthma
Detailed Description:
This is a randomized stratified double-blind placebo-controlled multicenter multinational study in subjects with uncontrolled asthma despite optimal treatment Following confirmation of eligibility subjects will be randomly assigned on Day 0 to 1 of 4 dose groups 1 mgkg CAT-354 5 mgkg CAT-354 10 mgkg CAT or Placebo to match all doses of CAT-354 Doses of the assigned treatment will be administered on three occasions 28 days apart Subjects will be assessed for efficacy including airway hyper-responsiveness AHR safety pharmacokinetic pharmacodynamics and immunogenicity until Day 84 post-first dose
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2007-002090-31 | EUDRACT_NUMBER | None | None |