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New shot could shrink nasal polyps and ease stuffy nose

NCT ID NCT06834360

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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Phase 3 trial tests itepekimab, an injectable drug, in 216 adults with chronic sinusitis and nasal polyps that are not well-controlled by standard nasal sprays. Participants receive itepekimab or a placebo for 52 weeks, plus a nasal spray. The study measures changes in polyp size and nasal congestion. It aims to see if itepekimab can improve symptoms and reduce the need for surgery or steroids.

What this could mean

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

Active substance
itepekimab
What this could lead to
If it works, this could provide a new treatment option to shrink nasal polyps and ease congestion for people whose symptoms are not controlled by standard sprays.
What could go wrong
This is a Phase 3 trial, but results are not yet known. The drug may not work better than placebo, and side effects are possible. It is an add-on therapy, not a standalone cure.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

216 people

The number who actually took part.

Started

Feb 2025

Expected to finish

Oct 2027

An estimate. End dates often move.

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: * Participants must be 18 years of age or older. * Participants with a history of chronic rhinosinusitis with nasal polyps (CRSwNP) for at least 1 year prior to screening * Participants must have at least one of the following features: * Prior sinonasal surgery for nasal polyps (NP). * Worsening symptoms of chronic rhinosinusitis (CRS) requiring treatment with systemic corticosteroid(s) (SCS) within the prior 1 year before screening (Visit 1). * An endoscopic bilateral Nasal Polyp Score (NPS) of at least 5 out of maximum score of 8 (with a minimum score of 2 in each nasal cavity) at screening and randomization. * Ongoing symptoms (for at least 12 weeks before Visit 1) of: * Nasal congestion/blockade/obstruction with moderate or severe (symptom severity score 2 or 3) at Visit 1 and a weekly average severity of greater than 1 in the week before randomization (Visit 2), AND * At least one of the following two symptoms: loss of smell or rhinorrhea (anterior/posterior). * A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least 1 of the following conditions applies: * Is not a women of childbearing potential (WOCBP), OR * Is a WOCBP and agrees to use a contraceptive method that is highly effective, with a failure rate of \<1% during the study (at a minimum until 20 weeks after the last dose of study intervention). Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply: * Participants with a history of clinically significant renal, hepatic, metabolic, neurologic, hematologic, ophthalmologic, respiratory (excluding those with asthma and aspirin-exacerbated respiratory disease (AERD) which may be included in the study), gastrointestinal, cardiovascular, cerebrovascular, or other significant medical illness or disorder, which, in the judgment of the Investigator, could interfere with the study or require treatment that might interfere with the study. * Participants who are currently smoking tobacco and/or vaping, or participants in whom smoking/vaping cessation has occurred \<6 months prior to Screening (Visit 1). Nicotine replacement therapy and/or noninhaled tobacco product use are not considered current smoking of tobacco. * Participants meet any contraindications for mometasone furoate nasal spray (MFNS) such as hypersensitivity to MFNS or any of its components; or participants with uncontrolled opportunistic infections. * Participants with a history of a severe systemic hypersensitivity reaction to a mAb. * Participants with conditions/concomitant diseases making them non-evaluable at Visit 1 or for the primary efficacy endpoint. * Participants with nasal cavity malignant tumor and benign tumors (eg, papilloma, blood boil etc). * Participants with severe uncontrolled asthma with history of 2 and/or more exacerbations, requiring SCS or 1 hospitalization requiring SCS in the past year. * History of concomitant lung disease (other than asthma, eg, COPD, interstitial lung disease) which in the opinion of the Investigator could interfere with performance and interpretation of spirometry. * Participants treated with intranasal corticosteroid(s) (INCS) (MFNS is permitted), intranasal emitting devices/stents, nasal spray using exhalation delivery system such as XhanceTM during the screening period. In Japan and China INCS other than MFNS are permitted. * Participants who have undergone any sinus intranasal surgery (including polypectomy) within 6 months before Visit 1. * Participants who received SCS 1 month prior to Screening (Visit 1) or during the screening period (between Visit 1 and Visit 2). * Known allergy to itepekimab or its excipients, or any drug or other allergy that, in the opinion of the Investigator, contraindicates participation in this study. 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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As listed by the trial registrant

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

Chronic rhinosinusitis with nasal polyps

Contacts and locations

Locations

  • Advanced ENT & Allergy - Louisville- Site Number : 8400007

    Louisville, Kentucky, 40220, United States

  • Advanced Research Institute - New Port Richey- Site Number : 8400014

    New Port Richey, Florida, 34653, United States

  • Allergy, Asthma and Clinical Research- Site Number : 8400002

    Oklahoma City, Oklahoma, 73120, United States

  • Cedars-Sinai Medical Center- Site Number : 8400030

    Los Angeles, California, 90048, United States

  • Centro de Pesquisa Clínica de Marília - CPCLIM- Site Number : 0760002

    Marília, São Paulo, 17504-072, Brazil

  • Clinica de Alergia Martti Antila- Site Number : 0760003

    Sorocaba, São Paulo, 18040-425, Brazil

  • Ear and Sinus Institute- Site Number : 8400048

    Fort Worth, Texas, 76104, United States

  • Excel ENT of Alabama- Site Number : 8400052

    Birmingham, Alabama, 35244, United States

  • Fundação Faculdade Regional de Medicina de São José do Rio Preto- Site Number : 0760005

    São José do Rio Preto, São Paulo, 15090-000, Brazil

  • Investigational Site Number : 0320001

    Buenos Aires, 1414, Argentina

  • Investigational Site Number : 0320002

    Buenos Aires, 1121, Argentina

  • Investigational Site Number : 0320003

    Mendoza, 5500, Argentina

  • Investigational Site Number : 0320004

    Corrientes, 3400, Argentina

  • Investigational Site Number : 0320005

    San Miguel de Tucumán, Tucumán Province, 4000, Argentina

  • Investigational Site Number : 0360001

    Spearwood, Western Australia, 6163, Australia

  • Investigational Site Number : 0360002

    Brisbane, Queensland, 4029, Australia

  • Investigational Site Number : 0360003

    Bella Vista, New South Wales, 2153, Australia

  • Investigational Site Number : 0560001

    Leuven, 3000, Belgium

  • Investigational Site Number : 0560002

    Ghent, 9000, Belgium

  • Investigational Site Number : 0560004

    Gesves, Namur, 5340, Belgium

  • Investigational Site Number : 0560006

    Alken, 3570, Belgium

  • Investigational Site Number : 1240003

    Québec, Quebec, G1V 4W2, Canada

  • Investigational Site Number : 1240012

    Québec, Quebec, G2J 0C4, Canada

  • Investigational Site Number : 1240014

    Ottawa, Ontario, K1G 6C6, Canada

  • Investigational Site Number : 1240015

    Cambridge, Ontario, N1R 8L4, Canada

  • Investigational Site Number : 1240017

    Vancouver, British Columbia, V6A 2W1, Canada

  • Investigational Site Number : 1240019

    Burlington, Ontario, L7R 3P9, Canada

  • Investigational Site Number : 1520001

    Concepción, Biobio, 4070094, Chile

  • Investigational Site Number : 1520002

    Quillota, Valparaiso, 2260877, Chile

  • Investigational Site Number : 1520003

    Santiago, Reg Metropolitana de Santiago, 7500505, Chile

  • Investigational Site Number : 1520004

    Talcahuano, Biobio, 2687000, Chile

  • Investigational Site Number : 1560001

    Beijing, 100730, China

  • Investigational Site Number : 1560002

    Jinan, 250022, China

  • Investigational Site Number : 1560003

    Yantai, 264001, China

  • Investigational Site Number : 1560004

    Chengdu, 610017, China

  • Investigational Site Number : 1560006

    Shenyang, 110004, China

  • Investigational Site Number : 1560009

    Zibo, 255036, China

  • Investigational Site Number : 1560012

    Jingzhou, 434020, China

  • Investigational Site Number : 1560014

    Wuhan, 430060, China

  • Investigational Site Number : 1560017

    Taiyuan, 030001, China

  • Investigational Site Number : 1560019

    Hangzhou, 310003, China

  • Investigational Site Number : 1560020

    Baotou, 014040, China

  • Investigational Site Number : 1560021

    Nanning, 530021, China

  • Investigational Site Number : 1560023

    Taiyuan, 030001, China

  • Investigational Site Number : 1560024

    Suzhou, 215006, China

  • Investigational Site Number : 1560025

    Chongqing, 400016, China

  • Investigational Site Number : 2030001

    Prague, 150 06, Czechia

  • Investigational Site Number : 2030002

    Hradec Králové, 500 05, Czechia

  • Investigational Site Number : 2030003

    Pardubice, 532 03, Czechia

  • Investigational Site Number : 2030004

    Prague, 100 34, Czechia

  • Investigational Site Number : 2030005

    Pilsen, 305 99, Czechia

  • Investigational Site Number : 2080001

    Aarhus, 8200, Denmark

  • Investigational Site Number : 2080002

    Køge, 4600, Denmark

  • Investigational Site Number : 2080004

    Copenhagen, 2100, Denmark

  • Investigational Site Number : 2500001

    Nantes, 44093, France

  • Investigational Site Number : 2500004

    Marseille, 13005, France

  • Investigational Site Number : 2500005

    Toyama, 939-2716, Japan

  • Investigational Site Number : 2500007

    Toulouse, 31059, France

  • Investigational Site Number : 2500010

    Poitiers, 86021, France

  • Investigational Site Number : 2500011

    Bordeaux, 33076, France

  • Investigational Site Number : 2500014

    Pontoise, 95300, France

  • Investigational Site Number : 2760001

    Dresden, 01307, Germany

  • Investigational Site Number : 2760002

    Leipzig, 04103, Germany

  • Investigational Site Number : 2760005

    Hamburg, 20246, Germany

  • Investigational Site Number : 2760006

    Dresden, 01139, Germany

  • Investigational Site Number : 2760007

    Mainz, 55131, Germany

  • Investigational Site Number : 2760008

    Villingen-Schwenningen, 78052, Germany

  • Investigational Site Number : 3480001

    Szeged, 6720, Hungary

  • Investigational Site Number : 3480005

    Budapest, 1026, Hungary

  • Investigational Site Number : 3760001

    Nahariya, 2210001, Israel

  • Investigational Site Number : 3760002

    Rehovot, 7610001, Israel

  • Investigational Site Number : 3760003

    Haifa, 3104802, Israel

  • Investigational Site Number : 3760004

    Jerusalem, 9112001, Israel

  • Investigational Site Number : 3800001

    Milan, Milano, 20132, Italy

  • Investigational Site Number : 3800003

    Catania, 95123, Italy

  • Investigational Site Number : 3800005

    Naples, Napoli, 80131, Italy

  • Investigational Site Number : 4840001

    Guadalajara, Jalisco, 44100, Mexico

  • Investigational Site Number : 4840002

    Veracruz, 91900, Mexico

  • Investigational Site Number : 4840007

    Chihuahua City, 31217, Mexico

  • Investigational Site Number : 4840008

    Monterrey, Nuevo León, 64718, Mexico

  • Investigational Site Number : 5280001

    Utrecht, 3584 CX, Netherlands

  • Investigational Site Number : 5280002

    Amsterdam, 1081 HV, Netherlands

  • Investigational Site Number : 6160001

    Bielsko-Biala, Silesian Voivodeship, 43-300, Poland

  • Investigational Site Number : 6160002

    Lodz, Lódzkie, 90-302, Poland

  • Investigational Site Number : 6160004

    Poznan, Greater Poland Voivodeship, 60-693, Poland

  • Investigational Site Number : 6160005

    Wroclaw, Lower Silesian Voivodeship, 50-750, Poland

  • Investigational Site Number : 6420001

    Bucharest, 022328, Romania

  • Investigational Site Number : 6420002

    Brasov, 500283, Romania

  • Investigational Site Number : 6420003

    Brasov, 500091, Romania

  • Investigational Site Number : 7240002

    Santander, Cantabria, 39008, Spain

  • Investigational Site Number : 7240004

    L'Hospitalet de Llobregat, Catalunya [Cataluña], 08907, Spain

  • Investigational Site Number : 7240006

    Barcelona, Barcelona [Barcelona], 08003, Spain

  • Investigational Site Number : 7240008

    Pamplona, Navarre, 31008, Spain

  • Investigational Site Number : 7240010

    Madrid, 28034, Spain

  • Investigational Site Number : 7240012

    Madrid, 28040, Spain

  • Investigational Site Number : 7920001

    Bursa, 16059, Turkey (Türkiye)

  • Investigational Site Number : 7920002

    Istanbul, 34360, Turkey (Türkiye)

  • Investigational Site Number : 7920003

    Ankara, 06230, Turkey (Türkiye)

  • Investigational Site Number : 8260001

    London, London, City of, W2 1NY, United Kingdom

  • Investigational Site Number : 8260002

    Wigan, Lancashire, Wn6 9ep, United Kingdom

  • Investigational Site Number : 8260003

    Taunton, Somerset, TA1 5DA, United Kingdom

  • Johns Hopkins Hospital- Site Number : 8400017

    Baltimore, Maryland, 21287, United States

  • One Of A Kind Clinical Research Center- Site Number : 8400034

    Napa, California, 94558, United States

  • Private Practice - Dr. Nelson Rosário- Site Number : 0760001

    Curitiba, Paraná, 80810-100, Brazil

  • Spartanburg-Greer ENT & Allergy- Site Number : 8400039

    Greer, South Carolina, 29650, United States

  • Thomas Jefferson University Hospital- Site Number : 8400044

    Philadelphia, Pennsylvania, 19107, United States

  • University of Cincinnati Medical Center- Site Number : 8400022

    Cincinnati, Ohio, 45219, United States

  • University of Florida - Jacksonville- Site Number : 8400053

    Jacksonville, Florida, 32209, United States

  • University of Illinois at Chicago- Site Number : 8400003

    Chicago, Illinois, 60607, United States

  • Velocity Clinical Research - Lafayette- Site Number : 8400026

    Lafayette, Louisiana, 70508, United States

  • Velocity Clinical Research - San Diego- Site Number : 8400041

    La Mesa, California, 91942, United States

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