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Head-to-Head: which biologic works best for nasal polyps and asthma?

NCT ID NCT04998604

Disease control Sponsor: Sanofi Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This completed phase 4 trial directly compared two injectable drugs, dupilumab (Dupixent) and omalizumab (Xolair), in 360 adults with severe chronic rhinosinusitis with nasal polyps and asthma. The main goals were to see which drug better reduced polyp size and improved sense of smell after 24 weeks. Researchers also tracked symptom relief and quality of life. The study provides head-to-head evidence to guide treatment choices for this challenging condition.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Dupilumab (Dupixent) and Omalizumab (Xolair)
What this could lead to
If dupilumab proves better than omalizumab, it could offer a more effective treatment option for people with severe nasal polyps and asthma, improving breathing and quality of life.
What could go wrong
This is a completed phase 4 trial, so results are already known. However, individual responses vary, and both drugs have side effects like injection reactions or infections. The findings may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

360 people

The number who actually took part.

Started

Sep 2021

Finished

Dec 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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. * 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.

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Conditions

The condition(s) this trial relates to.

asthma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Asthma Chronic rhinosinusitis with nasal polyps

Contacts and locations

Locations

  • Advanced ENT and Allergy Site Number : 8400013

    Louisville, Kentucky, 40220, United States

  • Allergy, Asthma and Clinical Research Center Site Number : 8400037

    Oklahoma City, Oklahoma, 73120, United States

  • Asthma Allergy & Immunology Clinical Research Unit Site Number : 8400027

    Tampa, Florida, 33613, United States

  • Cedars Sinai Medical Center Site Number : 8400026

    Los Angeles, California, 90048, United States

  • Chryaslis Clinical Research Site Number : 8400017

    St. George, Utah, 84790, United States

  • Cleveland Clinic Foundation Site Number : 8400029

    Cleveland, Ohio, 44195, United States

  • Eastern Virginia Medical School Site Number : 8400010

    Norfolk, Virginia, 23507, United States

  • Essential Medical Research, LLC Site Number : 8400024

    Tulsa, Oklahoma, 74137, United States

  • Investigational Site Number : 0560001

    Ghent, 9000, Belgium

  • Investigational Site Number : 0560002

    Leuven, 3000, Belgium

  • Investigational Site Number : 0560003

    Woluwe-Saint-Lambert, 1200, Belgium

  • Investigational Site Number : 1240002

    Montreal, Quebec, H4A 3J1, Canada

  • Investigational Site Number : 1240003

    Québec, G1V 4G5, Canada

  • Investigational Site Number : 1240004

    London, Ontario, N6A 5A5, Canada

  • Investigational Site Number : 2030001

    Hradec Králové, 50005, Czechia

  • Investigational Site Number : 2030002

    Pardubice, 53203, Czechia

  • Investigational Site Number : 2030003

    Ostrava - Poruba, 70852, Czechia

  • Investigational Site Number : 2030004

    Praha 5 - Motole, 15006, Czechia

  • Investigational Site Number : 2030006

    Prague, 12808, Czechia

  • Investigational Site Number : 2030007

    Benešov, 256 01, Czechia

  • Investigational Site Number : 2030008

    Prague, 14059, Czechia

  • Investigational Site Number : 2030010

    Prague, 10034, Czechia

  • Investigational Site Number : 2030012

    Pilsen, 30599, Czechia

  • Investigational Site Number : 2080001

    Copenhagen, 2100, Denmark

  • Investigational Site Number : 2080003

    Aarhus, 8200, Denmark

  • Investigational Site Number : 2460002

    Tampere, 33520, Finland

  • Investigational Site Number : 2460003

    Helsinki, 00029 HUS, Finland

  • Investigational Site Number : 2500002

    Lille, 59037, France

  • Investigational Site Number : 2500004

    Marseille, 13005, France

  • Investigational Site Number : 2500005

    Montpellier, 34295, France

  • Investigational Site Number : 2500006

    La Roche-sur-Yon, 85925, France

  • Investigational Site Number : 2500007

    Toulouse, 31059, France

  • Investigational Site Number : 2500008

    Le Kremlin-Bicêtre, 94275, France

  • Investigational Site Number : 2500009

    Créteil, 94010, France

  • Investigational Site Number : 2760001

    Münster, 48149, Germany

  • Investigational Site Number : 2760002

    Berlin, 13353, Germany

  • Investigational Site Number : 2760003

    München, 81377, Germany

  • Investigational Site Number : 2760004

    Düsseldorf, 40225, Germany

  • Investigational Site Number : 3480001

    Szeged, 6725, Hungary

  • Investigational Site Number : 3480002

    Pécs, 7621, Hungary

  • Investigational Site Number : 3480004

    Budapest, 1115, Hungary

  • Investigational Site Number : 3480005

    Debrecen, 4026, Hungary

  • Investigational Site Number : 3480006

    Edelény, 3780, Hungary

  • Investigational Site Number : 3480007

    Budapest, 1083, Hungary

  • Investigational Site Number : 3800001

    Rozzano, Lombardy, 20089, Italy

  • Investigational Site Number : 3800002

    Rome, Lazio, 00168, Italy

  • Investigational Site Number : 3800003

    Catania, 95123, Italy

  • Investigational Site Number : 3800004

    Florence, 50134, Italy

  • Investigational Site Number : 3800005

    Varese, 21100, Italy

  • Investigational Site Number : 3800006

    Milan, 20132, Italy

  • Investigational Site Number : 4840002

    Chihuahua City, 31000, Mexico

  • Investigational Site Number : 4840003

    Guadalajara, Jalisco, 44100, Mexico

  • Investigational Site Number : 4840004

    Durango, 34000, Mexico

  • Investigational Site Number : 6160001

    Krakow, 30-033, Poland

  • Investigational Site Number : 6160004

    Poznan, Greater Poland Voivodeship, 60-693, Poland

  • Investigational Site Number : 6160005

    Katowice, Silesian Voivodeship, 40-611, Poland

  • Investigational Site Number : 6160006

    Środa Wielkopolska, 63000, Poland

  • Investigational Site Number : 6160007

    Lodz, 90141, Poland

  • Investigational Site Number : 6160008

    Warsaw, Masovian Voivodeship, 04-141, Poland

  • Investigational Site Number : 6200001

    Matosinhos Municipality, 4454-509, Portugal

  • Investigational Site Number : 6200003

    Aveiro, 3814-501, Portugal

  • Investigational Site Number : 6200005

    Almada, 2801-951, Portugal

  • Investigational Site Number : 6200006

    Guimarães, 4810-061, Portugal

  • Investigational Site Number : 6200007

    Santa Maria da Feira, 4520-211, Portugal

  • Investigational Site Number : 6420002

    Brasov, 500283, Romania

  • Investigational Site Number : 6420004

    Craiova, 200222, Romania

  • Investigational Site Number : 7240001

    Seville, Andalusia, 41009, Spain

  • Investigational Site Number : 7240003

    Jerez de la Frontera, Cádiz, 11407, Spain

  • Investigational Site Number : 7240004

    Madrid / Madrid, Madrid, Comunidad de, 28040, Spain

  • Investigational Site Number : 7240005

    Barcelona, Barcelona [Barcelona], 08036, Spain

  • Investigational Site Number : 7240006

    Pamplona, Navarre, 31080, Spain

  • Investigational Site Number : 7240007

    Majadahonda, Madrid, 28222, Spain

  • Investigational Site Number : 7240008

    L'Hospitalet de Llobregat, Barcelona [Barcelona], 08907, Spain

  • Investigational Site Number : 7520001

    Stockholm, 171 76, Sweden

  • Investigational Site Number : 7520002

    Lund, 221 85, Sweden

  • Investigational Site Number : 7520003

    Gothenburg, 413 45, Sweden

  • Investigational Site Number : 8260001

    Newcastle upon Tyne, NE7 7DN, United Kingdom

  • Investigational Site Number : 8260002

    Manchester, M23 9LT, United Kingdom

  • Investigational Site Number : 8260003

    Wigan, Lancashire, WN6 9EP, United Kingdom

  • Northwell Health Site Number : 8400044

    Great Neck, New York, 11021, United States

  • Northwestern University Site Number : 8400001

    Chicago, Illinois, 60611, United States

  • Optimed Research, LTD Site Number : 8400014

    Columbus, Ohio, 43235, United States

  • Oregon Health & Science University Site Number : 8400031

    Portland, Oregon, 97239, United States

  • University of Illinois

    Chicago, Illinois, 60612, United States

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

    Columbia, Missouri, 65212, United States

  • University of Rochester Site Number : 8400015

    Rochester, New York, 14642, United States

  • University of Texas Health Science Center- Site Number : 8400019

    Houston, Texas, 77030, United States

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