Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2026-01-07 @ 2:50 PM
Study NCT ID:
NCT02573233
Status:
COMPLETED
Last Update Posted:
2022-04-04
First Post:
2015-10-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of Dupilumab's Effects on Airway Inflammation in Patients With Asthma
Sponsor:
Sanofi
Organization:
Study Overview
Official Title:
An Exploratory, Double-blind, Placebo-controlled Study of the Effects of Dupilumab on Airway Inflammation of Adults With Persistent Asthma
Status:
COMPLETED
Status Verified Date:
2022-03
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:
EXPEDITION
Brief Summary:
Primary Objective:
To evaluate the effect of dupilumab, compared to placebo, on airway inflammation in participants with persistent asthma.
Secondary Objective:
To assess the safety, tolerability, and immunogenicity of dupilumab compared to placebo.
To evaluate the effect of dupilumab, compared to placebo, on airway inflammation in participants with persistent asthma.
Secondary Objective:
To assess the safety, tolerability, and immunogenicity of dupilumab compared to placebo.
Detailed Description:
The total study duration for each participant was between approximately 29 and maximum of 30 weeks, consisting of a screening period of 5 weeks and optional up to 7 additional days, a treatment period of 12 weeks, and a post-treatment period of 12 weeks.
Participants who completed the treatment period could be eligible to participate in an open-label extension study.
Participants who completed the treatment period could be eligible to participate in an open-label extension study.
Study Oversight
Has Oversight DMC:
True
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?:
None
Is an FDA AA801 Violation?: