Ignite Creation Date:
2024-05-06 @ 3:34 PM
Last Modification Date:
2024-10-26 @ 1:52 PM
Study NCT ID:
NCT04678856
Status:
COMPLETED
Last Update Posted:
2024-02-14
First Post:
2020-12-16
Brief Title:
Dupilumab in CRSsNP
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
A Randomized Double-blind Placebo-controlled Study to Evaluate the Efficacy and Safety of Dupilumab in Patients With Uncontrolled Chronic Rhinosinusitis Without Nasal Polyposis CRSsNP
Status:
COMPLETED
Status Verified Date:
2024-02
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:
Liberty CRSsNP
Brief Summary:
Primary Objective
To evaluate the efficacy of dupilumab as assessed by the reduction at Week 24 in sinus opacification on computerized tomography CT scan in the dupilumab group only
Secondary Objectives
To evaluate the efficacy of dupilumab as assessed by the reduction at Week 24 in sinus opacification on CT scan and sinus total symptom score sTSS compared to placebo
To evaluate the safety and tolerability of dupilumab in CRSsNP patients compared to placebo
To evaluate the pharmacokinetics PK of dupilumab in CRSsNP patients compared to placebo
Assessment of immunogenicity to dupilumab over time compared to placebo
To evaluate the efficacy of dupilumab as assessed by the reduction at Week 24 in sinus opacification on computerized tomography CT scan in the dupilumab group only
Secondary Objectives
To evaluate the efficacy of dupilumab as assessed by the reduction at Week 24 in sinus opacification on CT scan and sinus total symptom score sTSS compared to placebo
To evaluate the safety and tolerability of dupilumab in CRSsNP patients compared to placebo
To evaluate the pharmacokinetics PK of dupilumab in CRSsNP patients compared to placebo
Assessment of immunogenicity to dupilumab over time compared to placebo
Detailed Description:
The duration of study for each participant will include 2-4 weeks of screening period 24-52 weeks randomized investigational medicinal product IMP intervention period and 12 weeks of follow-up period
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?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U1111-1246-7522 | REGISTRY | None | None |
| 2020-003117-35 | EUDRACT_NUMBER | ICTRP | None |