Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06454240
Status:
RECRUITING
Last Update Posted:
2024-06-12
First Post:
2024-06-06
Brief Title:
A Proof-of-concept Study of Lunsekimig Compared With Placebo in Adults With Chronic Rhinosinusitis With Nasal Polyps
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
A Randomized Phase 2 Double-blind Placebo-controlled Parallel-group 2-arm Study to Assess the Efficacy Safety and Tolerability of Subcutaneous Lunsekimig in Adult Participants With Chronic Rhinosinusitis With Nasal Polyps CRSwNP
Status:
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:
None
Brief Summary:
This is a parallel Phase 2 2-arm multicenter randomized double-blind placebo-controlled proof-of-concept study for treatment of CRSwNP
The purpose of this study is to assess the efficacy safety and tolerability of add-on therapy with subcutaneous lunsekimig in adult participants aged 18 to 70 years inclusive with CRSwNP who are inadequately controlled on intranasal corticosteroid treatment Participants with and without co-morbid asthma will be included in the study and lung function will be assessed in both groups
The study duration will be up to approximately 40 weeks per participant including 4 weeks of screening run-in period 24 weeks of intervention period and 12 weeks of follow-up
The purpose of this study is to assess the efficacy safety and tolerability of add-on therapy with subcutaneous lunsekimig in adult participants aged 18 to 70 years inclusive with CRSwNP who are inadequately controlled on intranasal corticosteroid treatment Participants with and without co-morbid asthma will be included in the study and lung function will be assessed in both groups
The study duration will be up to approximately 40 weeks per participant including 4 weeks of screening run-in period 24 weeks of intervention period and 12 weeks of follow-up
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U1111-1300-6978 | OTHER | ICTRP | None |
| 2024-511261-11 | REGISTRY | None | None |