Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2025-12-28 @ 12:03 AM
Study NCT ID:
NCT05878093
Status:
COMPLETED
Last Update Posted:
2025-09-25
First Post:
2023-05-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Dupilumab in Chinese Adult Participants With CRSwNP
Sponsor:
Sanofi
Organization:
Study Overview
Official Title:
A Randomized, Double-blind, Placebo-controlled Efficacy and Safety Study of Dupilumab, in Chinese Adult Participants With Chronic Rhinosinusitis With Nasal Polyposis (CRSwNP) on a Background Therapy With Intranasal Corticosteroids
Status:
COMPLETED
Status Verified Date:
2025-09
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:
This is a parallel group, Phase 3, 2-arm study for treatment. The purpose of this study is to evaluate dupilumab subcutaneous (SC) injections compared to placebo in Chinese adult participants with CRSwNP, on a background therapy with intranasal corticosteroids (budesonide nasal spray).
Study details include:
* The study duration will be up to 40 weeks.
* The treatment duration will be up to 24 weeks.
* The number of visits will be 7.
Study details include:
* The study duration will be up to 40 weeks.
* The treatment duration will be up to 24 weeks.
* The number of visits will be 7.
Detailed Description:
up to 40 weeks
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| U1111-1256-9711 | REGISTRY | ICTRP | View |