Ignite Creation Date:
2024-05-06 @ 9:09 AM
Last Modification Date:
2024-10-26 @ 12:10 PM
Study NCT ID:
NCT02912468
Status:
COMPLETED
Last Update Posted:
2019-07-25
First Post:
2016-09-21
Brief Title:
A Controlled Clinical Study of Dupilumab in Patients With Bilateral Nasal Polyps
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
A Randomized 24-Week Treatment Double-blind Placebo-controlled Efficacy and Safety Study of Dupilumab 300 mg Every Other Week in Patients With Bilateral Nasal Polyposis on a Background Therapy With Intranasal Corticosteroids
Status:
COMPLETED
Status Verified Date:
2019-07
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-24
Brief Summary:
Primary Objective
To evaluate the efficacy of dupilumab 300 milligram mg every 2 weeks q2w compared to placebo on a background of mometasone furoate nasal spray MFNS in reducing nasal congestionobstruction NC severity and endoscopic nasal polyp score NPS in participants with bilateral nasal polyposis NP In addition for Japan participants reduction in computed tomography CT scan opacification of the sinuses was a coprimary objective
Secondary Objectives
To evaluate the efficacy of dupilumab in improving total symptoms score TSS
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 Japan
To evaluate ability of dupilumab in reducing proportion of participants requiring treatment with systemic corticosteroids or NP surgery
To evaluate the effect of dupilumab on participant reported outcomes and health related quality of life outcome by sinonasal outcome test-22 SNOT-22
To evaluate the effect of dupilumab in the subgroups of participants with prior surgery and co-morbid asthma including non-steroid antiinflammatory drug NSAID exacerbated respiratory disease ERD
To evaluate residual effect in follow up
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 milligram mg every 2 weeks q2w compared to placebo on a background of mometasone furoate nasal spray MFNS in reducing nasal congestionobstruction NC severity and endoscopic nasal polyp score NPS in participants with bilateral nasal polyposis NP In addition for Japan participants reduction in computed tomography CT scan opacification of the sinuses was a coprimary objective
Secondary Objectives
To evaluate the efficacy of dupilumab in improving total symptoms score TSS
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 Japan
To evaluate ability of dupilumab in reducing proportion of participants requiring treatment with systemic corticosteroids or NP surgery
To evaluate the effect of dupilumab on participant reported outcomes and health related quality of life outcome by sinonasal outcome test-22 SNOT-22
To evaluate the effect of dupilumab in the subgroups of participants with prior surgery and co-morbid asthma including non-steroid antiinflammatory drug NSAID exacerbated respiratory disease ERD
To evaluate residual effect in follow up
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 expected to be up to 52 weeks that consisted of a 4-weeks run-in period 24-weeks treatment period and a 24-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 |
|---|---|---|---|
| 2015-003101-42 | EUDRACT_NUMBER | None | None |
| U1111-1178-5390 | OTHER | UTN | None |