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New drug shows promise for sinus fungal disease

NCT ID NCT04684524

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Sep 04, 2026 · Updated 3 times

Summary

This study tested the drug dupilumab in 62 people with allergic fungal rhinosinusitis, a condition where fungus causes severe sinus inflammation. Participants received either dupilumab or a placebo injection for 52 weeks. The main goal was to see if dupilumab could reduce sinus blockage seen on CT scans and improve symptoms like nasal congestion and sense of smell.

What this could mean

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

Active substance
Dupilumab (a biologic drug given as an injection under the skin)
What this could lead to
If it works, this could offer a new treatment option for people with allergic fungal rhinosinusitis, potentially reducing sinus blockage and the need for rescue treatments.
What could go wrong
This is a small Phase 3 trial with only 62 participants, so results may not apply to everyone. The drug may not work better than placebo, and side effects are possible.

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

62 people

The number who actually took part.

Started

Dec 2020

Finished

Mar 2025

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

6 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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 6 years of age (or the minimum legal age for adolescents in the country of the investigational site) at the time of signing the informed consent. Participants with the diagnosis of AFRS adapted from criteria by Bent and Kuhn (meeting all): * IgE mediated inflammatory response to fungal hyphae (specific IgE serology or skin test) Evidence of sensitization to fungus by skin testing (at screening or documented historical positive skin test in the previous 12 months), or positive fungal-specific IgE in serum at screening. * Nasal polyposis confirmed by nasal endoscopy at screening. * Characteristic CT signs to be performed during screening period and can include any of the below signs as assessed by central reader: * hyperdensities * bony demineralization * bone erosion of sinus * Eosinophilic mucin/mucus identified within 5 years prior to screening or at screening with or without positive fungal stain AFRS patients with the following: * An endoscopic NPS of at least 2 out of 4 for unilateral polyps or 3 out of 8 for bilateral polyps at Visit 1 (central reading) and Visit 2 (local reading) and, * Sinus opacification in CT scan with an LMK score of 9 for patients with unilateral polyps or 12 for patients with bilateral polyps during screening period and, Body weight ≥15 kg Exclusion Criteria: * Patients with nasal conditions/concomitant nasal diseases making them non-evaluable at Visit 1 or for the primary efficacy * Nasal cavity malignant tumor and benign tumors. * Known of fungal invasion into sinus tissue. * Severe concomitant illness(es) that, in the investigator's judgment, would adversely affect the patient's 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 * 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. * Treatment with commercially available dupilumab within 12 months, participation in prior dupilumab clinical trial, or discontinued dupilumab use due to adverse event. * Patients who are treated with intranasal corticosteroid drops; intranasal steroid emitting devices/stents; nasal spray using exhalation delivery system, such as Xhance™, during screening period. * Patients who are on intranasal corticosteroids (INCS) spray unless they have received stable dose for at least 4 weeks prior to Visit 1. * Patients who have undergone sinus intranasal surgery (including polypectomy) within 6 months prior to Visit 1. * Patients 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 patient 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. - Patients received SCS during screening period. - 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.

Allergic Fungal Sinusitis

As listed by the trial registrant

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

Allergic fungal rhinosinusitis

Contacts and locations

Locations

  • Advanced ENT and Allergy Site Number : 8400004

    Louisville, Kentucky, 40220, United States

  • Alamo ENT Associates Site Number : 8400018

    San Antonio, Texas, 78258, United States

  • Asthma Allergy & Immunology Clinical Research Unit Site Number : 8400001

    Tampa, Florida, 33613, United States

  • Eastern Virginia Medical School (EVMS) Medical Group - Otola Site Number : 8400008

    Norfolk, Virginia, 23507, United States

  • Emory University Hospital Midtown Campus Site Number : 8400009

    Atlanta, Georgia, 30308, United States

  • Investigational Site Number : 0320001

    CABA, Buenos Aires, C1425BEN, Argentina

  • Investigational Site Number : 0320002

    Buenos Aires, C1121ABE, Argentina

  • Investigational Site Number : 0320003

    CABA, Buenos Aires, C1414AIF, Argentina

  • Investigational Site Number : 0320004

    Mendoza, 5500, Argentina

  • Investigational Site Number : 0320005

    Rosario, Santa Fe Province, 2000, Argentina

  • Investigational Site Number : 1240001

    Vancouver, British Columbia, V6Z 1Y6, Canada

  • Investigational Site Number : 1560001

    Beijing, 100730, China

  • Investigational Site Number : 1560002

    Nanjing, 210029, China

  • Investigational Site Number : 1560003

    Chengdu, 610041, China

  • Investigational Site Number : 1560004

    Changsha, 410013, China

  • Investigational Site Number : 1560005

    Beijing, 100050, China

  • Investigational Site Number : 1560006

    Hangzhou, 310003, China

  • Investigational Site Number : 1560008

    Taiyuan, 030001, China

  • Investigational Site Number : 1560009

    Shanghai, 200030, China

  • Investigational Site Number : 1560011

    Qingdao, 266555, China

  • Investigational Site Number : 1560012

    Hefei, China

  • Investigational Site Number : 1560013

    Fuzhou, 350005, China

  • Investigational Site Number : 3560003

    Coimbatore, 641028, India

  • Investigational Site Number : 3560006

    Jodhpur, 342005, India

  • Investigational Site Number : 3560008

    New Delhi, 110 062., India

  • Investigational Site Number : 3760001

    Petah Tikva, 49100, Israel

  • Investigational Site Number : 3760002

    Rehovot, 76100, Israel

  • Investigational Site Number : 3920001

    Meguro-ku, Tokyo, 153-8515, Japan

  • Investigational Site Number : 3920003

    Shinagawa-ku, Tokyo, 141-0001, Japan

  • Investigational Site Number : 3920006

    Shizuoka, Shizuoka, 420-0853, Japan

  • Investigational Site Number : 3920008

    Bunkyo-ku, Tokyo, 113-8431, Japan

  • Investigational Site Number : 3920009

    Shinjuku-ku, Tokyo, 160-8582, Japan

  • Investigational Site Number : 3920010

    Isehara, Kanagawa, 2591193, Japan

  • Investigational Site Number : 6820001

    Riyadh, 22252, Saudi Arabia

  • Investigational Site Number : 6820002

    Riyadh, 12713, Saudi Arabia

  • Investigational Site Number : 7920001

    Istanbul, 34093, Turkey (Türkiye)

  • Investigational Site Number : 7920003

    Izmir, 35340, Turkey (Türkiye)

  • Investigational Site Number : 7920004

    Adana, 01380, Turkey (Türkiye)

  • Investigational Site Number : 7920005

    Malatya, 44280, Turkey (Türkiye)

  • Investigational Site Number : 7920006

    Izmir, 35100, Turkey (Türkiye)

  • Investigational Site Number : 7920007

    Istanbul, 34865, Turkey (Türkiye)

  • National Allergy and Asthma Research, LLC Site Number : 8400002

    Charleston, South Carolina, 29407, United States

  • REX Clinical Trials Site Number : 8400017

    Beaumont, Texas, 77701-3713, United States

  • South Louisiana Ear, Nose, Throat and Facial Plastic Surgery Site Number : 8400019

    Mandeville, Louisiana, 70471, United States

  • USA Clinical Trials Site Number : 8400020

    San Antonio, Texas, 78229, United States

  • Ut- Houston Medical School Site Number : 8400010

    Houston, Texas, 77030, United States

  • Vanderbilt University Medical Center Site Number : 8400013

    Nashville, Tennessee, 37232, United States