EValuating trEatment RESponses of Dupilumab Versus Omalizumab in Type 2 Patients

Completed · Phase 4 · Has a placebo group

Conditions studied: Chronic Rhinosinusitis With Nasal Polyps, Asthma

In brief

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

Key facts

Study ID

NCT04998604

Run by

Sanofi

People needed

360

Starts

2021-09-27

Expected to finish

2024-12-27

Last updated by the study team

2025-10-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.
• History of systemic hypersensitivity or anaphylaxis to dupilumab and omalizumab, including any excipient
• Treatment with a live (attenuated) vaccine within 4 weeks before Visit 1 (screening visit).
• The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Where it is running

• 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
• Allergy, Asthma and Clinical Research Center Site Number : 8400037 — Oklahoma City, Oklahoma, United States
• Essential Medical Research, LLC Site Number : 8400024 — Tulsa, Oklahoma, United States
• Oregon Health & Science University Site Number : 8400031 — Portland, Oregon, United States
• University of Texas Health Science Center- Site Number : 8400019 — Houston, Texas, United States
• Chryaslis Clinical Research Site Number : 8400017 — St. George, Utah, United States
• Eastern Virginia Medical School Site Number : 8400010 — Norfolk, Virginia, United States
• Investigational Site Number : 0560001 — Ghent, Belgium
• Investigational Site Number : 0560002 — Leuven, Belgium
• Investigational Site Number : 0560003 — Woluwe-Saint-Lambert, Belgium
• Investigational Site Number : 1240004 — London, Ontario, Canada
• Investigational Site Number : 1240002 — Montreal, Quebec, Canada
• Investigational Site Number : 1240003 — Québec, Canada
• Investigational Site Number : 2030007 — Benešov, Czechia
• Investigational Site Number : 2030001 — Hradec Králové, Czechia
• Investigational Site Number : 2030003 — Ostrava - Poruba, Czechia
• Cedars Sinai Medical Center Site Number : 8400026 — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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