Can dupixent ease sinusitis without polyps? new trial hints at answer
NCT ID NCT04362501
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This Phase 2 study tested dupilumab (Dupixent) in 33 adults with chronic sinusitis but no nasal polyps. Participants received injections every two weeks for six months. The main goal was to see if the drug improves sinus symptoms and quality of life compared to a placebo.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- dupilumab (Dupixent)
- What this could lead to
- If successful, this could provide a new treatment option for people with chronic sinusitis who don't have nasal polyps, improving symptoms and quality of life.
- What could go wrong
- This is an early Phase 2 trial with only 33 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 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
33 people
The number who actually took part.
- Started
-
Oct 2020
- Finished
-
Sep 2025
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 75 years
- 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 Hide 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: * Age 18-75 with history of chronic sinusitis without polyps * SNOT-22 score of at least 30 at baseline * Bilateral Lund-Mackay CT score 4 or more and/or MLK endoscopy score 4 or more * Blood eosinophil count of at least 300/ul and/or SPT positive to at least 5/30 allergens, or eosinophil less than 300/ul and SPT negative (Th2 low group). * Prior oral steroid or antibiotic use is acceptable but not required for entry * Informed Consent * Effective birth control (with \<1% failure rate), post menopausal or documented abstinence * Women ≥50 years old would be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatment. * All male subjects who are sexually active must agree to use an acceptable method of contraception (condom or vasectomy) from V1-V16 Exclusion Criteria: * Immunosuppression other than oral steroids in the past 3 months * History of nasal polyps within the past 3 years or noted at screening by CT or endoscopy * Acute sinusitis at the time of entry * Acute fungal sinusitis at the time of entry * Uncontrolled asthma * Cystic fibrosis * Primary immune deficiency including CVID * Other; serious concomitant illness or sinus disease that the investigator determines to disqualify * A history of known immunodeficiency disorder including HIV * History of hepatitis B or C * Primary ciliary dyskinesia (PCD) * Use of any biologic medication within the last 5 months or 5 half-lives whichever is longer * Receipt of any investigational non-biologic within 5 half-lives prior to visit 0 * Receipt of immunoglobulin or blood products within 30 days prior to V1 * Scheduled sinus surgery * Significant structural abnormalities or severe septal deviation * Symptomatic or untreated life threatening cardiopulmonary disorders * History of cancer not in remission at least 5 years prior to the date informed consent * Subjects who are febrile (≥38°C; ≥100.4°F); * Untreated helminth parasitic infection within 24 weeks prior to informed consent * Pregnant or nursing * Any other medical illness that precludes study involvement * History of anaphylaxis to any biologic therapy or vaccine * The following medications are excluded: * Any type of anti-interleukin therapy (e.g. Omalizumab, benralizumab, dupilumab mepolizumab, reslizumab, lebrikizumab etc.) within the last 5 months or 5 half-lives whichever is longer * Receipt of any investigational non-biologic within 30 days or 5 half-lives prior to visit 0, whichever is longer. * Immunosuppressive medications such as methotrexate, azathioprine, cyclosporine, tacrolimus * Receipt of immunoglobulin or blood products within 30 days prior to the date informed consent is obtained. * Daily high dose aspirin greater than 81mg daily * Allergen Immunotherapy during build-up phase during the last three months * Other medications that could interfere with the action of dupilumab or suppress eosinophils
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21224, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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