New hope for stubborn nasal polyps: dupilumab shows promise
NCT ID NCT05049122
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study tested the drug dupilumab in 25 adults with chronic sinusitis and nasal polyps that weren't helped by other treatments. Participants received injections for up to 52 weeks. The main goal was to see if polyp size decreased by at least 1 point on a standard scale after 24 weeks. The study also looked at safety and other measures of improvement.
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)
- What this could lead to
- If successful, this could offer a new treatment option for people with nasal polyps that don't respond to standard therapies.
- What could go wrong
- This is a small, single-arm study with only 25 participants, so results may not apply to everyone. As a Phase 4 trial, it confirms safety and effectiveness in a specific group, but unexpected 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 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
-
25 people
The number who actually took part.
- Started
-
Oct 2021
- Finished
-
Jul 2023
- 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 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: * Participants ≧18 years of age. * Participants with bilateral sinonasal polyposis that despite prior treatment with systemic corticosteroids (SCS) anytime within the past 2 years; and/or had a medical contraindication / intolerance to SCS; and/or had prior surgery for NP at the screening visit, had: * An endoscopic bilateral NPS of at least 5 out of a maximum score of 8 (with a minimum score of 2 in each nasal cavity). * Ongoing symptoms (for at least 8 weeks prior to Visit \[V\] 1) of nasal congestion/blockage/obstruction with moderate or severe symptom severity (score 2 or 3) at V1 and a weekly average severity of greater than 1 at the time of enrollment (V2), and loss of smell, rhinorrhea (anterior/posterior). * Participant's body weight \> 30 kg at V1. * Signed written informed consent. Exclusion Criteria: * Participant with conditions/concomitant diseases making them non evaluable at V1 or for the primary efficacy endpoint such as: Antrochoanal polyps; Nasal septal deviation that would occlude at least one nostril; Acute sinusitis, nasal infection or upper respiratory infection; Ongoing rhinitis medicamentosa; Eosinophilic granulomatosis with polyangiitis (Churg-Strauss syndrome), granulomatosis with polyangiitis (Wegener's granulomatosis), Young's syndrome, Kartagener's syndrome or other dyskinetic ciliary syndromes, concomitant cystic fibrosis; Radiologic suspicion, or confirmed invasive or expansive fungal rhinosinusitis; * Participant with nasal cavity malignant tumor and benign tumors (eg, papilloma, blood boil, etc). * Participant diagnosed with, suspected of, or at high risk of endoparasitic infection, and/or use of antiparasitic drug within 2 weeks before V1 or during screening * Undergone any and/or sinus intranasal surgery within 6 months before V1. * Participant who had participated in prior dupilumab clinical study or had been treated with commercially available dupilumab 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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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Investigational site JAPAN
Japan, Japan
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Other studies related to the condition(s) this trial covers.
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