Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06393946
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-01
First Post:
2024-04-10
Brief Title:
Study in Adults With Severe Chronic Rhinosinusitis With Nasal Polyposis Treated With Dupilumab in France
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
Observational Study in Adults With Severe Chronic Rhinosinusitis With Nasal Polyposis CRSwNP Treated With Dupilumab in France
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
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:
OPALE
Brief Summary:
This is a multicentre non-interventional single arm study that aims to describe the treatment patterns in France patients characteristics disease characteristics prior treatments for Severe chronic rhinosinusitis with nasal polyposis and treatment prescription modalities As well as to assess the clinical outcome after initiation of dupilumab Dupixent and safety of the product during the two years of treatment
Detailed Description:
None
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 |
|---|---|---|---|
| U1111-1264-3068 | REGISTRY | ICTRP | None |