Ignite Creation Date:
2024-05-06 @ 1:54 AM
Last Modification Date:
2024-10-26 @ 11:11 AM
Study NCT ID:
NCT01920893
Status:
COMPLETED
Last Update Posted:
2017-06-26
First Post:
2013-08-08
Brief Title:
An Evaluation of Dupilumab in Patients With Nasal Polyposis And Chronic Symptoms Of Sinusitis
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
A Randomized Double-Blind Phase 2 Placebo Controlled 2 Arm Study To Evaluate Dupilumab In Patients With Bilateral Nasal Polyposis And Chronic Symptoms Of Sinusitis
Status:
COMPLETED
Status Verified Date:
2017-06
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:
Primary Objective
To evaluate the efficacy of dupilumab SAR231893REGN668 in the treatment of bilateral Nasal Polyposis NP by assessment of the endoscopic nasal polyp score NPS in comparison to placebo
Secondary Objectives
To evaluate effect of dupilumab with regards to
symptoms of sinusitis
sinus computed tomography CT scan
NPS in the sub-group of participants with co-morbid asthma
Safety and tolerability
To evaluate the efficacy of dupilumab SAR231893REGN668 in the treatment of bilateral Nasal Polyposis NP by assessment of the endoscopic nasal polyp score NPS in comparison to placebo
Secondary Objectives
To evaluate effect of dupilumab with regards to
symptoms of sinusitis
sinus computed tomography CT scan
NPS in the sub-group of participants with co-morbid asthma
Safety and tolerability
Detailed Description:
Screening period 4 weeks Randomized Treatment Period 16 weeks Post-Treatment Period 16 weeks 36 weeks
To ensure at least 28 participants with co-morbid asthma needed for subgroup analysis recruitment of NP participants without co-morbid asthma would stop when approximately 28 participants without asthma were randomized
To ensure at least 28 participants with co-morbid asthma needed for subgroup analysis recruitment of NP participants without co-morbid asthma would stop when approximately 28 participants without asthma were randomized
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 |
|---|---|---|---|
| U1111-1130-6475 | OTHER | UTN | None |
| 2013-001803-35 | EUDRACT_NUMBER | None | None |