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New hope for sinus sufferers: drug targets stubborn inflammation

NCT ID NCT06691113

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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 26, 2026 · Updated 2 times

Summary

This study tests an experimental drug called itepekimab in 66 adults with chronic sinusitis who have not improved with standard treatments. Participants receive either the drug or a placebo for 24 weeks. The goal is to see if itepekimab can reduce sinus inflammation and ease symptoms like congestion, runny nose, and facial pain.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

66 people

The number who actually took part.

Started

Dec 2024

Finished

Aug 2026

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 18 years of age or older. * Participants must have ongoing symptoms of nasal congestion/obstruction at least 12 consecutive weeks before Visit 1 and a Nasal Congestion Score (NCS) ≥2 at Visit 1 (day score) and Visit 2 (weekly average score). * Participants must have sinus Total Symptom Score (sTSS) (NC, rhinorrhea, facial pain/pressure) ≥5 at Visit 1 (day score) and Visit 2 (weekly average score). * Participants must have at least one of the following features: * Prior sinonasal surgery (as protocol defined) for chronic rhinosinusitis (CRS). * Treatment with systemic corticosteroid(s) (SCS) within the prior 2 years before Screening (Visit 1) * Worsening symptoms of CRS in the past 2 years which would have required treatment with SCS, however participant is intolerant or has a contraindication to SCS. * Participants must have bilateral inflammation of paranasal sinuses with bilateral ethmoid and maxillary opacification on screening CT scan. Participants must have ≥25% opacification of the ethmoid sinuses and ≥25% opacification of at least 1 maxillary sinus by central reading of CT scan. * Participants must have a Sino-Nasal Outcome Test-22-Items (SNOT-22) score of ≥20 at Visit 1 and Visit 2. * Participants who have received a stable dose of mometasone furoate nasal spray (MFNS) for at least 3 weeks before Visit 2. * 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 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). * Radiological suspicion or confirmed invasive or expansive fungal rhinosinusitis. * Have any clinically significant diseases or disorders (eg, cardiovascular, pulmonary, gastrointestinal, liver, kidney, neurological, musculoskeletal, endocrine, metabolic, psychiatric, physical impairment) that, in the opinion of the Investigator, may put the subject at risk by participating in the study, or interfere with the subject's intervention, assessment, or influence the results of the study, or have compliance issues with the study. * Sinus surgery within 6 months before Screening (Visit 1) * Participants who received SCS 1 month prior to Screening (Visit 1) or during the screening period (between Visit 1 and Visit 2). * Participants treated with other intranasal corticosteroid(s) (INCS) (only study provided AxMP \[MFNS\] is permitted), intranasal emitting devices/stents, nasal spray using exhalation delivery system such as Xhance™ during the screening period. * Participants with a history of severe systemic hypersensitivity reaction to mAb. * Known allergy to itepekimab or to its excipients. Any drug or other allergy that, in the opinion of the Investigator, contraindicates participation in the study. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

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Conditions

The condition(s) this trial relates to.

chronic rhinosinusitis

As listed by the trial registrant

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

Chronic rhinosinusitis without nasal polyps

Contacts and locations

Locations

  • Advanced Research Associates (ARA) Professionals- Site Number : 8400002

    Miami, Florida, 33176, United States

  • Alamo ENT Associates- Site Number : 8400026

    San Antonio, Texas, 78258, United States

  • Allervie Clinical Research - Birmingham- Site Number : 8400006

    Birmingham, Alabama, 35209, United States

  • Azienda Ospedaliero-Universitaria Pisana-Site Number : 3800003

    Pisa, 56124, Italy

  • ENT Associates of Texas - McKinne- Site Number : 8400013

    McKinney, Texas, 75070, United States

  • Eastern Virginia Medical School (EVMS) Medical Group- Site Number : 8400007

    Norfolk, Virginia, 23510, United States

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Site Number : 3800001

    Rome, Roma, 00168, Italy

  • Fondazione Policlinico Universitario Campus Bio-Medico-Site Number : 3800002

    Rome, Roma, 00128, Italy

  • Investigational Site Number : 0320001

    Buenos Aires, 1425, Argentina

  • Investigational Site Number : 0320003

    San Miguel de Tucumán, Tucumán Province, 4000, Argentina

  • Investigational Site Number : 0320004

    Corrientes, 3400, Argentina

  • Investigational Site Number : 0560001

    Leuven, 3000, Belgium

  • Investigational Site Number : 0560002

    Ghent, 9000, Belgium

  • Investigational Site Number : 0560003

    Brussels, 1200, Belgium

  • Investigational Site Number : 0560004

    Gesves, 5340, Belgium

  • Investigational Site Number : 1240001

    Québec, Quebec, G1V 4G5, Canada

  • Investigational Site Number : 1240002

    Montreal, Quebec, H4A 3J1, Canada

  • Investigational Site Number : 1240003

    Québec, Quebec, G1V 4W2, Canada

  • Investigational Site Number : 1240005

    London, Ontario, N6A 4V2, Canada

  • Investigational Site Number : 1240009

    Trois-Rivières, Quebec, G8T 7A1, Canada

  • Investigational Site Number : 1240012

    Québec, Quebec, G2J 0C4, Canada

  • Investigational Site Number : 1520001

    Santiago, Reg Metropolitana de Santiago, 7500505, Chile

  • Investigational Site Number : 1520002

    Concepción, Biobio, 4070094, Chile

  • Investigational Site Number : 1520003

    Santiago, Reg Metropolitana de Santiago, 7500692, Chile

  • Investigational Site Number : 1560001

    Beijing, 100730, China

  • Investigational Site Number : 1560002

    Shanghai, 200127, China

  • Investigational Site Number : 1560003

    Zibo, 255036, China

  • Investigational Site Number : 1560004

    Baotou, 014040, China

  • Investigational Site Number : 2500004

    Marseille, 13005, France

  • Investigational Site Number : 2500005

    Montpellier, 34295, France

  • Investigational Site Number : 2500010

    Poitiers, 86021, France

  • Investigational Site Number : 2500012

    La Rochelle, 17019, France

  • 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 : 6160001

    Warsaw, Masovian Voivodeship, 00-909, Poland

  • Investigational Site Number : 6160002

    Poznan, Greater Poland Voivodeship, 60-693, Poland

  • Investigational Site Number : 6160004

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

  • Investigational Site Number : 6160006

    Krakow, Lesser Poland Voivodeship, 31-513, Poland

  • Investigational Site Number : 6160008

    Lodz, Lódzkie, 90-302, Poland

  • Investigational Site Number : 6200001

    Guimarães, 4800-055, Portugal

  • Investigational Site Number : 6200002

    Porto, 3814-501, Portugal

  • Investigational Site Number : 6420001

    Brasov, 500283, Romania

  • Investigational Site Number : 6420002

    Bucharest, 022328, Romania

  • Investigational Site Number : 7240001

    Seville, Sevilla, 41009, Spain

  • Investigational Site Number : 7240002

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

  • Investigational Site Number : 7240003

    Barcelona, Barcelona [Barcelona], 08003, Spain

  • Investigational Site Number : 7240004

    Jerez de la Frontera, Cádiz, 11407, Spain

  • Investigational Site Number : 7240005

    Pamplona, Navarre, 31008, Spain

  • Investigational Site Number : 7240006

    Madrid, 28040, Spain

  • Modena Allergy + Asthma- Site Number : 8400005

    La Jolla, California, 92037, United States

  • Sacramento Ear Nose & Throat - Roseville- Site Number : 8400008

    Roseville, California, 95661, United States

  • Treasure Valley Medical Research- Site Number : 8400022

    Boise, Idaho, 83706, United States

  • United Medical Doctors - Murrieta- Site Number : 8400001

    Murrieta, California, 92563, United States

  • Western States Clinical Research- Site Number : 8400009

    Wheat Ridge, Colorado, 80033, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.