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Can a drug that calms inflammation ease chronic sinusitis?

NCT ID NCT04678856

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 30, 2026 · Last updated Jul 31, 2026 · Updated 1 time

Summary

This trial tests whether dupilumab, an injectable drug that blocks certain inflammatory signals, can reduce sinus swelling and improve symptoms like loss of smell and runny nose in adults with chronic sinusitis who do not have nasal polyps. Participants receive either dupilumab or a placebo for 24 weeks. The study measures changes in CT scans and symptom scores to see if the drug offers relief for this hard-to-treat condition.

What this could mean

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

Active substance
an injectable drug called dupilumab
What this could lead to
If it works, this could offer a new treatment option for people with chronic sinusitis who don't have nasal polyps and haven't been helped by standard therapies.
What could go wrong
This is a small, early-phase trial, so results may not apply to everyone. Dupilumab can cause injection-site reactions and allergic reactions, and it may not improve symptoms for 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 2

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

Participants

71 people

The number who actually took part.

Started

Dec 2020

Finished

Jan 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 years of age at the time of signing the informed consent form (ICF). * Participants must have bilateral inflammation of paranasal sinuses in CT scan with LMK ≥8 and bilateral ethmoid opacification before randomization. * Participants must have ongoing symptoms of loss of smell and rhinorrhea (anterior/posterior) of any severity, with or without facial pain/pressure for at least 12 consecutive weeks by Visit 1. * Participants must have ongoing symptoms of nasal congestion (NC)/obstruction at least 12 consecutive weeks before Visit 1 and a NC score of ≥ 2 at Visit 1 (day score) and Visit 2 (weekly average score). * Participants must have sTSS (NC, rhinorrhea, facial pain/pressure) ≥5 at Visit 1 (day score) and Visit 2 (weekly average score). * Participants must have one of the 2 following features: * Prior sinonasal surgery (see note at end of section 5.2 for definitions of sinonasal surgery) for CRS, * Treatment with systemic corticosteroids (SCS) therapy for CRS as defined by any dose and duration within the prior 2 years before screening (Visit 1) or intolerance/contraindication to SCS. Exclusion Criteria: * Participants with nasal conditions/concomitant nasal diseases such as nasal polyposis in endoscopy at Visit 1 or with history of nasal polyposis etc., making them non-evaluable at Visit 1 or for the primary efficacy * Nasal cavity malignant tumor and benign tumors. * Forced expiratory volume (FEV1) ≤50% of predicted normal at Visit 1. * Radiologic suspicion or confirmed invasive or expansive fungal rhinosinusitis. * Severe concomitant illness(es) that, in the investigator's judgment, would adversely affect participation in the study * Active tuberculosis or non-tuberculous mycobacterial infection, or a history of incompletely treated tuberculosis unless documented adequately treated. * Diagnosed active endoparasitic infections; suspected or high risk of endoparasitic infection * Known or suspected immunodeficiency * History of malignancy within 5 years before Visit 1, except completely treated in situ carcinoma of the cervix, and completely treated and resolved nonmetastatic squamous or basal cell carcinoma of the skin. * Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, or antifungals within 2 weeks before the Screening Visit 1 or during the screening period. * History of systemic hypersensitivity or anaphylaxis to dupilumab or any of its excipients. * Participants in prior dupilumab clinical trial or have been treated with commercially available dupilumab within 12 months or who discontinued dupilumab use due to adverse event. * Participants who are treated with intranasal corticosteroid drops; intranasal steroid emitting devices/stents; nasal spray using exhalation delivery system, such as Xhance™, during screening period. * Participants on unstable dose of intranasal corticosteroids (INCS) spray 4 weeks prior to Screening Visit (Visit1) and during screening period. * Participants who have undergone sinus intranasal surgery (including polypectomy) within 6 months prior to Visit 1. * Participants who have taken: * Biologic therapy/systemic immunosuppressant to treat inflammatory disease or autoimmune disease within 5 half-lives prior to Visit 1 * Any investigational mAb within 5 half-lives prior to Visit 1 * Anti-IgE therapy (omalizumab) within 4 months prior to Visit 1. * Treatment with a live (attenuated) vaccine within 4 weeks prior to Visit 1 * Leukotriene antagonists/modifiers unless participant is on a continuous treatment for at least 30 days prior to Visit 1. * Initiation of allergen immunotherapy within 3 months prior to Visit 1 or a plan to begin therapy or change its dose during the screening or treatment period. * Participants received SCS during screening period (between Visit 1 and Visit 2). * Either intravenous immunoglobulin therapy and/or plasmapheresis within 30 days prior to Screening Visit (Visit 1). 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 paranasal sinus disorder Respiration Disorders respiratory system disorder sinusitis

As listed by the trial registrant

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

Chronic rhinosinusitis without nasal polyps Chronic sinusitis Respiratory disorder Sinus disorder Sinusitis

Contacts and locations

Locations

  • Alamo ENT Associates Site Number : 8400021

    San Antonio, Texas, 78258, United States

  • Bensch Clinical Research LLC Site Number : 8400015

    Stockton, California, 95207, United States

  • Colorado Allergy and Asthma Centers, PC Site Number : 8400003

    Denver, Colorado, 80230, United States

  • Eastern Virginia Medical School (EVMS) Medical Group - Otola Site Number : 8400009

    Norfolk, Virginia, 23507, United States

  • Essential Medical Research, LLC Site Number : 8400014

    Tulsa, Oklahoma, 74137, United States

  • Investigational Site Number : 0320001

    Ciudad Autonoma Buenos Aires, C1425BEN, Argentina

  • Investigational Site Number : 0320002

    Buenos Aires, C1121ABE, Argentina

  • Investigational Site Number : 0320003

    Ciudad Autonoma Buenos Aires, C1414AIF, Argentina

  • Investigational Site Number : 0560001

    Leuven, 3000, Belgium

  • Investigational Site Number : 0560002

    Ghent, 9000, Belgium

  • Investigational Site Number : 1240001

    Montreal, Quebec, H2X 3E4, Canada

  • Investigational Site Number : 1240002

    Trois-Rivières, Quebec, G8T 7A1, Canada

  • Investigational Site Number : 1240003

    Québec, G1V 4W2, Canada

  • Investigational Site Number : 1240005

    Québec, G1V 4G5, Canada

  • Investigational Site Number : 1240007

    Kingston, Ontario, K7L 2V7, Canada

  • Investigational Site Number : 1240010

    Hamilton, Ontario, L8L 2X2, Canada

  • Investigational Site Number : 1240012

    Montreal, Quebec, H4A 3J1, Canada

  • Investigational Site Number : 1240013

    Vancouver, British Columbia, V6Z 1Y6, Canada

  • Investigational Site Number : 1240016

    London, Ontario, N6A 4V2, Canada

  • Investigational Site Number : 1520001

    Santiago, Reg Metropolitana de Santiago, 8207257, Chile

  • Investigational Site Number : 1560001

    Beijing, 100730, China

  • Investigational Site Number : 1560005

    Changchun, 130021, China

  • Investigational Site Number : 1560006

    Shanghai, 200065, China

  • Investigational Site Number : 1560008

    Yantai, 264000, China

  • Investigational Site Number : 1560010

    Chongqing, 400016, China

  • Investigational Site Number : 1560013

    Changsha, 410013, China

  • Investigational Site Number : 3480001

    Pécs, 7621, Hungary

  • Investigational Site Number : 3480004

    Budapest, 1115, Hungary

  • Investigational Site Number : 4100002

    Seoul, Seoul-teukbyeolsi, 135-710, South Korea

  • Investigational Site Number : 4100003

    Seoul, Seoul-teukbyeolsi, 07061, South Korea

  • Investigational Site Number : 6200001

    Guimarães, 4810-061, Portugal

  • Investigational Site Number : 6200002

    Aveiro, 3810-501, Portugal

  • Investigational Site Number : 6200003

    Matosinhos Municipality, 4464-513, Portugal

  • Investigational Site Number : 6430001

    Stavropol, 355020, Russia

  • Investigational Site Number : 6430002

    Saint Petersburg, 197022, Russia

  • Investigational Site Number : 6430003

    Saint Petersburg, 197022, Russia

  • Investigational Site Number : 6430005

    Moscow, 121359, Russia

  • Investigational Site Number : 7240001

    Barcelona, Barcelona [Barcelona], 08036, Spain

  • Investigational Site Number : 7240002

    Seville, Andalusia, 41009, Spain

  • Investigational Site Number : 7240004

    Jerez de la Frontera, Cádiz, 11407, Spain

  • Investigational Site Number : 7240005

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

  • Investigational Site Number : 7240007

    Santander, Cantabria, 39008, Spain

  • Investigational Site Number : 7240008

    Pamplona, Navarre, 31008, Spain

  • Investigational Site Number : 7240009

    Madrid, Madrid, Comunidad de, 28027, Spain

  • Investigational Site Number : 7240010

    Madrid, 28034, Spain

  • Investigational Site Number : 7520001

    Stockholm, 171 76, Sweden

  • Investigational Site Number : 8040001

    Ivano-Frankivsk, 76018, Ukraine

  • Investigational Site Number : 8040002

    Kyiv, 03680, Ukraine

  • Investigational Site Number : 8040004

    Kharkiv, 61166, Ukraine

  • Investigational Site Number : 8040005

    Dnipro, 49006, Ukraine

  • Investigational Site Number : 8040007

    Kyiv, 04050, Ukraine

  • Investigational Site Number : 8040008

    Kyiv, 01033, Ukraine

  • Nebraska Medical Research Institute Site Number : 8400007

    Papillion, Nebraska, 68046, United States

  • Optimed Research, LTD Site Number : 8400017

    Columbus, Ohio, 43235, United States

  • Pharmaceutical Research & Consulting, Inc. Site Number : 8400006

    Dallas, Texas, 75231, United States

  • Sacramento Ear, Nose & Throat Site Number : 8400010

    Roseville, California, 95661, United States

  • University of Missouri Health System Site Number : 8400016

    Columbia, Missouri, 65212, United States

  • Vital Prospects Clinical Research Institute, P.C. Site Number : 8400004

    Tulsa, Oklahoma, 74136, United States

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