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EValuating trEatment RESponse...

EValuating trEatment RESponses of Dupilumab Versus Omalizumab in Type 2 Patients

Last Updated: 2025-10-23

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

360 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-27

Study Completion Date

2024-12-27

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Chronic Rhinosinusitis With Nasal Polyps Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Placebo injections will be administered as needed to blind the number of active dupilumab and omalizumab injections

Study Groups

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Dupilumab 300 mg Q2W

Participants received dupilumab 300 milligrams (mg) subcutaneous (SC) injection every 2 weeks (Q2W) for 24 weeks.

Group Type EXPERIMENTAL