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EValuating trEatment RESponses of Dupilumab Versus Omalizumab in Type 2 Patients | Clinical Trials | Clareo Health

COMPLETEDPHASE4

EValuating trEatment RESponses of Dupilumab Versus Omalizumab in Type 2 Patients

A Randomized, Double-blind, Head-to-head Comparison of Dupilumab Versus Omalizumab in Severe Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) and Comorbid Asthma Patients

NCT04998604•Sanofi

View on ClinicalTrials.gov

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

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Participant must be at least 18 (or the legal age of consent in the jurisdiction in which the study is taking place) years of age inclusive, at the time of signing the informed consent.
•Participants with bilateral sino-nasal polyposis, that despite prior treatment with Systemic corticosteroids (SCS) anytime within the past 2 years; and/or medical contraindication/intolerance to SCS; and/or prior surgery for NP have:
•* An endoscopic bilateral NPS of at least 5 out of a maximum score of 8 (with a minimum score of 2 in each nasal cavity) at visit 1; AND
•* Ongoing symptoms of Nasal congestion/blockade/obstruction and loss of smell for at least 8 weeks before screening (Visit 1), AND
•* Nasal congestion/blockade/obstruction and a weekly average severity greater than 1 in the 7 days before randomization (Visit 2) AND
•* loss of smell symptom severity score 2 or 3 at screening (Visit 1) and a weekly average severity of greater than 1 in the 7 days before randomization (Visit 2).
•Participants with a physician diagnosis of asthma based on the Global Initiative for Asthma (GINA) 2020 treated with low, medium or high dose inhaled corticosteroids (ICS) and a second controller (ie, LABA), a third controller is allowed but not mandatory. The dose regimen was to be stable for at least 1 month before Visit 1 (screening visit) and during the screening and run-in period.
•Asthma Control Questionnaire 5-question version (ACQ-5) score ≥1.5 at Visits 1 or 2.
•Treatment with intranasal mometasone ≥200 μg once daily (QD) (or equivalent of another INCS) for 1 month prior to Visit 1 and during the run-in period (for CRSwNP).
•Eligibility as per omalizumab drug-dosing table (serum IgE level ≥30 to ≤1500 IU/mL and body weight ≥30 to ≤150 kg) and ability to be dosed per the dosing table.

Exclusion Criteria

•Participants were excluded from the study if any of the following criteria apply:
•Participants who underwent any sinus intranasal surgery (including polypectomy) within 6 months before Visit 1.
•Participants who had a sino-nasal surgery changing the lateral wall structure of the nose, making impossible the evaluation of NPS.
•Participants with conditions/concomitant diseases making them non evaluable at Visit 1 or for the primary efficacy endpoint such as: Antrochoanal polyps, Nasal septal deviation that would occlude at least one nostril, Acute sinusitis, nasal infection, or upper respiratory infection.
•Severe asthma exacerbation requiring treatment with SCS in the last 4 weeks prior to Visit 1 and during screening.
•Severe concomitant illness(es) that, in the Investigator's judgment, would adversely affect the participant's participation in the study
•Diagnosed with, suspected of, or at high risk of endoparasitic infection, and/or use of antiparasitic drugs within 2 weeks before Visit 1 (screening visit) or during the screening and run-in period.
•History of human immunodeficiency virus (HIV) infection or positive HIV 1/2 serology at Visit 1 (screening visit).
•Known or suspected immunodeficiency, including history of invasive opportunistic infections
•Active malignancy or history of malignancy within 5 years before Visit 1 (screening visit), except completely treated in situ carcinoma of the cervix and completely treated and resolved non metastatic squamous or basal cell carcinoma of the skin.
+3 more criteria

Locations (87)

Cedars Sinai Medical Center Site Number : 8400026

Los Angeles, California, United States

Asthma Allergy & Immunology Clinical Research Unit Site Number : 8400027

Tampa, Florida, United States

Northwestern University Site Number : 8400001

Chicago, Illinois, United States

University of Illinois

Chicago, Illinois, United States

Advanced ENT and Allergy Site Number : 8400013

Louisville, Kentucky, United States

University of Missouri Health Care - University Hospital Site Number : 8400016

Columbia, Missouri, United States

Northwell Health Site Number : 8400044

Great Neck, New York, United States

University of Rochester Site Number : 8400015

Rochester, New York, United States

Cleveland Clinic Foundation Site Number : 8400029

Cleveland, Ohio, United States

Optimed Research, LTD Site Number : 8400014

Columbus, Ohio, United States

Key Dates

Start Date

September 27, 2021

Primary Completion Date

October 16, 2024

Completion Date

December 27, 2024

Last Updated

October 23, 2025

Enrollment

360

ACTUAL participants

Conditions

Chronic Rhinosinusitis With Nasal PolypsAsthma

Interventions

Dupilumab

DRUG

Omalizumab

DRUG

Placebo

DRUG

Blood Eosinophil Guided Versus Usual Care In The Management Of Mild To Moderate Asthma at Primary Care (BEAM)

NCT07486401

Asthma ExacerbationsBiomarkers / Blood+1 more

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RECRUITING

NHALES (Natural History of Asthma With Longitudinal Environmental Sampling)

NCT02327897

Asthma

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 23, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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EValuating trEatment RESponses of Dupilumab Versus Omalizumab in Type 2 Patients

Inclusion Criteria

Exclusion Criteria

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