Ignite Creation Date:
2024-05-06 @ 9:04 AM
Last Modification Date:
2024-10-26 @ 12:09 PM
Study NCT ID:
NCT02898454
Status:
COMPLETED
Last Update Posted:
2019-10-23
First Post:
2016-09-08
Brief Title:
Controlled Clinical Study of Dupilumab in Patients With Nasal Polyps
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
A Randomized Double-blind 52-week Placebo Controlled Efficacy and Safety Study of Dupilumab in Patients With Bilateral Nasal Polyposis on a Background Therapy With Intranasal Corticosteroids
Status:
COMPLETED
Status Verified Date:
2019-10
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:
SINUS-52
Brief Summary:
Primary Objective
To evaluate the efficacy of dupilumab 300 mg every 2 weeks q2w compared to placebo on a background of mometasone furoate nasal spray MFNS in reducing nasal congestion NCobstruction severity and endoscopic nasal polyp score NPS in participants with bilateral nasal polyps NP In addition for Japanese participants reduction in computed tomography CT scan opacification of the sinuses was a co-primary objective
Secondary Objectives
To evaluate the efficacy of dupilumab in improving total symptoms score
To evaluate the efficacy of dupilumab in improving sense of smell
To evaluate the efficacy of dupilumab in reducing CT scan opacification of the sinuses primary objective for Japanese participants
To evaluate ability of dupilumab in reducing proportion of participants who required treatment with systemic corticosteroids SCS or surgery for NP
To evaluate the effect of dupilumab on participant reported outcomes and health related quality of life
To evaluate the efficacy of dupilumab 300 mg q2w up to Week 52
To evaluate the efficacy of dupilumab 300 mg q2w up to Week 24 followed by 300 mg every 4 weeks q4w up to Week 52
To evaluate the effect of dupilumab in the subgroups of participants with prior surgery and comorbid asthma including non-steroid anti-inflammatory drug exacerbated respiratory disease
To evaluate the safety of dupilumab in participants with bilateral NP
To evaluate functional dupilumab concentrations systemic exposure and incidence of treatment emergent anti-drug antibodies
To evaluate the efficacy of dupilumab 300 mg every 2 weeks q2w compared to placebo on a background of mometasone furoate nasal spray MFNS in reducing nasal congestion NCobstruction severity and endoscopic nasal polyp score NPS in participants with bilateral nasal polyps NP In addition for Japanese participants reduction in computed tomography CT scan opacification of the sinuses was a co-primary objective
Secondary Objectives
To evaluate the efficacy of dupilumab in improving total symptoms score
To evaluate the efficacy of dupilumab in improving sense of smell
To evaluate the efficacy of dupilumab in reducing CT scan opacification of the sinuses primary objective for Japanese participants
To evaluate ability of dupilumab in reducing proportion of participants who required treatment with systemic corticosteroids SCS or surgery for NP
To evaluate the effect of dupilumab on participant reported outcomes and health related quality of life
To evaluate the efficacy of dupilumab 300 mg q2w up to Week 52
To evaluate the efficacy of dupilumab 300 mg q2w up to Week 24 followed by 300 mg every 4 weeks q4w up to Week 52
To evaluate the effect of dupilumab in the subgroups of participants with prior surgery and comorbid asthma including non-steroid anti-inflammatory drug exacerbated respiratory disease
To evaluate the safety of dupilumab in participants with bilateral NP
To evaluate functional dupilumab concentrations systemic exposure and incidence of treatment emergent anti-drug antibodies
Detailed Description:
The total study duration per participant was up to 68 weeks that consisted of a 4-weeks run-in period 52-weeks treatment period and a 12-weeks post treatment period
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 |
|---|---|---|---|
| U1111-1170-7180 | OTHER | UTN | None |
| 2015-001314-10 | EUDRACT_NUMBER | None | None |