Ignite Creation Date:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2025-12-30 @ 7:11 AM
Study NCT ID:
NCT04998604
Status:
COMPLETED
Last Update Posted:
2025-10-23
First Post:
2021-08-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
EValuating trEatment RESponses of Dupilumab Versus Omalizumab in Type 2 Patients
Sponsor:
Sanofi
Organization:
Study Overview
Official Title:
A Randomized, Double-blind, Head-to-head Comparison of Dupilumab Versus Omalizumab in Severe Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) and Comorbid Asthma Patients
Status:
COMPLETED
Status Verified Date:
2025-09
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:
EVEREST
Brief Summary:
Primary Objective
-To evaluate the efficacy of dupilumab compared to omalizumab in reducing the polyp size and improving sense of smell
Secondary Objectives
* To evaluate the efficacy of dupilumab in improving chronic rhinosinusitis with nasal polyps (CRSwNP) symptoms at Week 24 compared to omalizumab
* To evaluate the efficacy of dupilumab in improving CRSwNP total symptom score (TSS) at Week 24 compared to omalizumab
* To evaluate the effect of dupilumab on health related quality of life (HRQoL) at week 24 compared to omalizumab
* To evaluate the efficacy of dupilumab in improving nasal peak inspiratory flow at Week 24 compared to omalizumab
* To evaluate the effect of dupilumab on CRSwNP overall disease severity at Week 24 compared to omalizumab
* To evaluate the safety of dupilumab and omalizumab
-To evaluate the efficacy of dupilumab compared to omalizumab in reducing the polyp size and improving sense of smell
Secondary Objectives
* To evaluate the efficacy of dupilumab in improving chronic rhinosinusitis with nasal polyps (CRSwNP) symptoms at Week 24 compared to omalizumab
* To evaluate the efficacy of dupilumab in improving CRSwNP total symptom score (TSS) at Week 24 compared to omalizumab
* To evaluate the effect of dupilumab on health related quality of life (HRQoL) at week 24 compared to omalizumab
* To evaluate the efficacy of dupilumab in improving nasal peak inspiratory flow at Week 24 compared to omalizumab
* To evaluate the effect of dupilumab on CRSwNP overall disease severity at Week 24 compared to omalizumab
* To evaluate the safety of dupilumab and omalizumab
Detailed Description:
Study duration per participant will be 38 weeks. The study will comprise 3 periods: 28 days ± 3 days screening and run-in period; 24 weeks Randomized investigational medicinal product (IMP) intervention period; up to 12 weeks follow-up period.
Study Oversight
Has Oversight DMC:
False
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?: