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New drug could ease stuffy noses and shrink nasal polyps

NCT ID NCT06834347

Symptom relief 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tests a drug called itepekimab in adults with chronic sinusitis and nasal polyps that are not well controlled by standard treatments. About 231 participants will receive either itepekimab or a placebo as an add-on to their usual nasal spray. The goal is to see if the drug can shrink polyps and improve nasal congestion over 52 weeks.

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

231 people

The number who actually took part.

Started

Feb 2025

Expected to finish

Sep 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

  • ASST Santi Paolo e Carlo-Presidio Ospedale San Paolo-Site Number : 3800006

    Milan, Milano, 20142, Italy

  • Advanced Research Associates (ARA) Professionals- Site Number : 8400011

    Miami, Florida, 33176, United States

  • Alamo ENT Associates- Site Number : 8400065

    San Antonio, Texas, 78258, United States

  • Azienda Ospedale - Università Padova-Site Number : 3800008

    Padua, Padova, 35128, Italy

  • Azienda Ospedaliera Universitaria Careggi-Site Number : 3800011

    Florence, Firenze, 50134, Italy

  • Azienda Ospedaliero-Universitaria di Ferrara-Site Number: 3800004

    Cona, Ferrara, 44124, Italy

  • Breathe Clear Institute of Sinus and Allergy Relief- Site Number : 8400040

    Torrance, California, 90503, United States

  • Centro Internacional de Pesquisa Clínica (CIPES)- Site Number : 0760005

    São José dos Campos, São Paulo, 12230-001, Brazil

  • Deaconess Clinic Allergy East- Site Number : 8400056

    Evansville, Indiana, 47715, United States

  • ENT Associates of Texas - McKinne- Site Number : 8400062

    McKinney, Texas, 75070, United States

  • Eastern Virginia Medical School (EVMS) Medical Group- Site Number : 8400046

    Norfolk, Virginia, 23510, United States

  • Emory University School of Medicine- Grady Campus- Site Number : 8400047

    Atlanta, Georgia, 30303, United States

  • Essential Medical Research- Site Number : 8400066

    Tulsa, Oklahoma, 74137, United States

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Site Number: 3800002

    Rome, Roma, 00168, Italy

  • Hospital Israelita Albert Einstein- Site Number : 0760001

    São Paulo, 05651-901, Brazil

  • Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto- Site Number : 0760002

    Ribeirão Preto, São Paulo, 14049-900, Brazil

  • Houston Methodist Hospital- Site Number : 8400054

    Houston, Texas, 77030, United States

  • IRCCS Ospedale Policlinico San Martino-Site Number : 3800013

    Genoa, Genova, 16132, Italy

  • Investigational Site Number : 0320001

    Buenos Aires, 1425, Argentina

  • Investigational Site Number : 0320002

    La Plata, Buenos Aires, 1900, Argentina

  • Investigational Site Number : 0320003

    Mendoza, 5500, Argentina

  • Investigational Site Number : 0320004

    Rosario, Santa Fe Province, 2000, Argentina

  • Investigational Site Number : 0320005

    Buenos Aires, 1638, Argentina

  • Investigational Site Number : 0400001

    Vienna, 1090, Austria

  • Investigational Site Number : 0400002

    Linz, 4010, Austria

  • Investigational Site Number : 0400005

    Graz, 8036, Austria

  • Investigational Site Number : 1240001

    Québec, Quebec, G1V 4G5, Canada

  • Investigational Site Number : 1240002

    Montreal, Quebec, H4a 3j1, Canada

  • Investigational Site Number : 1240005

    London, Ontario, N6A 4V2, Canada

  • Investigational Site Number : 1520001

    Santiago, Reg Metropolitana de Santiago, 8207257, Chile

  • Investigational Site Number : 1520002

    Santiago, Reg Metropolitana de Santiago, 7500692, Chile

  • Investigational Site Number : 1520003

    Talca, Maule Region, 3465584, Chile

  • Investigational Site Number : 1520004

    Lo Barnechea, Reg Metropolitana de Santiago, 7691236, Chile

  • Investigational Site Number : 1520005

    Viña del Mar, Valparaiso, 2540364, Chile

  • Investigational Site Number : 1520006

    Valdivia, Los Ríos Region, 5110683, Chile

  • Investigational Site Number : 2460002

    Kuopio, 70210, Finland

  • Investigational Site Number : 2460003

    Helsinki, 00130, Finland

  • Investigational Site Number : 2460004

    Helsinki, 00029, Finland

  • Investigational Site Number : 2760001

    Tübingen, 72076, Germany

  • Investigational Site Number : 2760002

    Münster, 48149, Germany

  • Investigational Site Number : 2760003

    Würzburg, 97080, Germany

  • Investigational Site Number : 2760004

    Berlin, 10117, Germany

  • Investigational Site Number : 2760005

    Wiesbaden, 65205, Germany

  • Investigational Site Number : 2760007

    Frankfurt, 60318, Germany

  • Investigational Site Number : 2760008

    Hamburg, 22523, Germany

  • Investigational Site Number : 2760009

    Landsberg, 06188, Germany

  • Investigational Site Number : 3480001

    Pécs, 7621, Hungary

  • Investigational Site Number : 3480002

    Budapest, 1046, Hungary

  • Investigational Site Number : 3480003

    Nyíregyháza, 4400, Hungary

  • Investigational Site Number : 3480004

    Debrecen, 4032, Hungary

  • Investigational Site Number : 3760004

    Kefar Sava, 4428164, Israel

  • Investigational Site Number : 3760005

    Petah Tikva, 4941492, Israel

  • Investigational Site Number : 3760007

    Haifa, 3436212, Israel

  • Investigational Site Number : 3760009

    Tel Aviv, 6423906, Israel

  • Investigational Site Number : 3920001

    Fukuoka, 812-0053, Japan

  • Investigational Site Number : 3920002

    Odawara, Kanagawa, 250-8558, Japan

  • Investigational Site Number : 3920003

    Kumamoto, 860-0814, Japan

  • Investigational Site Number : 3920004

    Narita, Chiba, 286-8520, Japan

  • Investigational Site Number : 3920005

    Suwa, Nagano, 392-0027, Japan

  • Investigational Site Number : 3920006

    Fukui, 910-1104, Japan

  • Investigational Site Number : 3920008

    Tokyo, 153-8515, Japan

  • Investigational Site Number : 3920009

    Isehara, Kanagawa, 259-1193, Japan

  • Investigational Site Number : 3920010

    Ichikawa, Chiba, 272-0143, Japan

  • Investigational Site Number : 3920011

    Hiroshima, 734-0004, Japan

  • Investigational Site Number : 3920012

    Kusatsu, Shiga, 525-0066, Japan

  • Investigational Site Number : 3920013

    Niigata, 951-8520, Japan

  • Investigational Site Number : 3920014

    Yokohama, Kanagawa, 236-0037, Japan

  • Investigational Site Number : 4100001

    Seoul, Seoul-teukbyeolsi, 07061, South Korea

  • Investigational Site Number : 4100002

    Seoul, Seoul-teukbyeolsi, 06351, South Korea

  • Investigational Site Number : 4100003

    Seoul, Seoul-teukbyeolsi, 03080, South Korea

  • Investigational Site Number : 4100004

    Seoul, Seoul-teukbyeolsi, 03722, South Korea

  • Investigational Site Number : 4100005

    Cheonan-Si, Chungcheongnam-do, 31116, South Korea

  • Investigational Site Number : 4100006

    Seoul, 02841, South Korea

  • Investigational Site Number : 4100008

    Incheon, Incheon-gwangyeoksi, 21565, South Korea

  • Investigational Site Number : 4100009

    Seongnam-si, Gyeonggi-do, 13620, South Korea

  • Investigational Site Number : 4840003

    Durango, 34000, Mexico

  • Investigational Site Number : 4840004

    Chihuahua City, 31000, Mexico

  • Investigational Site Number : 5280002

    Leiderdorp, 2353 GA, Netherlands

  • Investigational Site Number : 5280004

    Alkmaar, 1815 JD, Netherlands

  • Investigational Site Number : 6160001

    Wroclaw, Lower Silesian Voivodeship, 53-149, Poland

  • Investigational Site Number : 6160002

    Warsaw, Masovian Voivodeship, 00-909, Poland

  • Investigational Site Number : 6160003

    Bialystok, Podlaskie Voivodeship, 15-756, Poland

  • Investigational Site Number : 6160004

    Wroclaw, Lower Silesian Voivodeship, 53-301, Poland

  • Investigational Site Number : 6160005

    Lublin, Lublin Voivodeship, 20-363, Poland

  • Investigational Site Number : 6160006

    Krakow, Lesser Poland Voivodeship, 31-513, Poland

  • Investigational Site Number : 6200001

    Santa Maria da Feira, 4520-211, Portugal

  • Investigational Site Number : 6200002

    Porto, 3814-501, Portugal

  • Investigational Site Number : 6200003

    Guimarães, 4800-055, Portugal

  • Investigational Site Number : 6200004

    Matosinhos Municipality, 4464-513, Portugal

  • Investigational Site Number : 7240001

    Majadahonda, Madrid, 28222, Spain

  • Investigational Site Number : 7240002

    Barcelona, Catalunya [Cataluña], 08036, Spain

  • Investigational Site Number : 7240003

    Santiago de Compostela, A Coruña [La Coruña], 15706, Spain

  • Investigational Site Number : 7240004

    Jerez de la Frontera, Cádiz, 11407, Spain

  • Investigational Site Number : 7240005

    Zaragoza, 50009, Spain

  • Investigational Site Number : 7240006

    Seville, Sevilla, 41009, Spain

  • Investigational Site Number : 7240007

    Santiago de Compostela, A Coruña [La Coruña], 15702, Spain

  • Investigational Site Number : 7240008

    Barcelona, Barcelona [Barcelona], 08022, Spain

  • Investigational Site Number : 7240009

    Sabadell, 08208, Spain

  • Investigational Site Number : 7520001

    Solna, 171 64, Sweden

  • Investigational Site Number : 7520002

    Lund, 221 85, Sweden

  • Investigational Site Number : 7520004

    Stockholm, 114 86, Sweden

  • Investigational Site Number : 7920001

    Istanbul, 34093, Turkey (Türkiye)

  • Investigational Site Number : 7920002

    Istanbul, 34865, Turkey (Türkiye)

  • Investigational Site Number : 7920003

    Ankara, 06230, Turkey (Türkiye)

  • Investigational Site Number : 8260001

    Newcastle upon Tyne, NE7 7DN, United Kingdom

  • Investigational Site Number : 8260002

    London, London, City of, NW1 2BU, United Kingdom

  • Investigational Site Number : 8260004

    Bradford, BD9 6RJ, United Kingdom

  • Investigational Site Number : 8260006

    Oxford, Oxfordshire, OX3 9DU, United Kingdom

  • Newport Native MD- Site Number : 8400031

    Newport Beach, California, 92663, United States

  • Northwell Health Physician Partners Rheumatology at Great Neck- Site Number : 8400028

    Great Neck, New York, 11021, United States

  • Orlando ENT Associates - Orlando- Site Number : 8400008

    Orlando, Florida, 32807, United States

  • Orso Health - Torrance - Hawthorne Boulevard- Site Number : 8400035

    Torrance, California, 90505, United States

  • Ospedale Bellaria-Site Number: 3800009

    Bologna, 40139, Italy

  • Paradisus Med Research - Miami- Site Number : 8400009

    Miami, Florida, 33185, United States

  • SSM Health Saint Louis University Hospital- Site Number : 8400005

    St Louis, Missouri, 63104, United States

  • Sacramento Ear Nose & Throat - Roseville- Site Number : 8400064

    Roseville, California, 95661, United States

  • Sensa Health- Site Number : 8400038

    Los Angeles, California, 90006, United States

  • TEN20 Clinical Research - Dallas- Site Number : 8400015

    Dallas, Texas, 75244, United States

  • Treasure Valley Medical Research- Site Number : 8400063

    Boise, Idaho, 83706, United States

  • University of Chicago Medical Center- Site Number : 8400018

    Chicago, Illinois, 60637, United States

  • University of Southern California (USC) / Keck Medicine of USC- Site Number : 8400037

    Arcadia, California, 91006, United States

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