A biologic shot may rewire nasal polyps for years of relief
NCT ID NCT05902325
First seen Aug 31, 2026 · Last updated Sep 01, 2026 · Updated 1 time
Summary
This trial tests whether mepolizumab, an antibody that blocks a key immune signal, can produce lasting improvements in people with severe nasal polyps. Participants receive twelve monthly injections and are followed for six months after stopping to see if benefits persist. Researchers also look for markers that predict who responds best, aiming to personalize treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Mepolizumab (Nucala), an injectable antibody that blocks IL-5, given every 4 weeks for 48 weeks.
- What this could lead to
- If it works, this could help doctors identify which patients with nasal polyps will benefit most from mepolizumab and may lead to longer-lasting relief without surgery.
- What could go wrong
- This is a small, single-center study without a placebo, so results may not apply broadly. Some patients may not respond, and the treatment carries risks like allergic reactions.
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
-
About 36 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Oct 2023
- Expected to finish
-
Dec 2026
An estimate. End dates often move.
- 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 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: * Bilateral NP, as diagnosed by endoscopy or historical CT scan * At least one NP surgery\* within the last 10 years. * Severe NP symptoms consistent with a need for surgery (obstruction VAS symptom score\>5, overall, VAS symptom score \>7, endoscopic bilateral NP score ≥4 \[with a score ≥2 in each nasal cavity\]). * Ongoing treatment with INCS (via spray or intranasal liquid steroid wash/douching) for ≥4 weeks prior to screening * ≥2 of the following CRS symptoms for at least 12 weeks: * Nasal blockage/obstruction/congestion * Nasal discharge (anterior/posterior nasal drip) * Facial pain/pressure * Reduction or loss of sense of smell Exclusion Criteria: * If as a result of a medical interview, physical examination, or screening investigation the physician responsible considers the participant unfit for the study. * Cystic fibrosis * Eosinophilic granulomatosis with polyangiitis (also known as Churg Strauss syndrome), Young's, Kartagener's or dyskinetic ciliary syndromes * Antrochoanal polyps * Nasal septal deviation occluding one nostril * Acute sinusitis or upper respiratory tract infection (URTI) at screening or 2 weeks prior to screening * Ongoing rhinitis medicamentosa (rebound or chemical-induced rhinitis) * Participants who have undergone any intranasal and/or sinus surgery (for example polypectomy, balloon dilatation or nasal stent insertion) within 6 months prior to V1 * Participants where NP surgery is contraindicated in the opinion of the Investigator * Participants with a known medical history of HIV infection. * Participants with a known, pre-existing parasitic infestation within 6 months prior to Visit 1. * Participants who are currently receiving or have received within 3 months (or 5 half-lives - whatever is the longest) prior to the screening visit, radiotherapy, or investigational medications/therapies. * Participants with a history of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation. Aspirin-sensitive participants are acceptable. * Participants with a history of allergic reaction to anti-IL-5 or other monoclonal antibody therapy. * Use of systemic corticosteroids (including oral corticosteroids) within 4 weeks prior to screening or planned use of such medications during the double-blind period * Treatments with biological or immunosuppressive treatment (other than Xolair) treatment within 5 terminal phase half-lives of Visit 1 * Omalizumab (Xolair) treatment in the 130 days prior to Visit 1 * Commencement or change of dose of allergen immunotherapy within the previous 3 months. * Pregnancy: Women who are pregnant or lactating or are planning on becoming pregnant during the study. Contraceptive use will be required with a double barrier method or documented effective surgical sterilization. * Immunocompromised subjects from disease or medication, other than oral corticosteroids. * Women of childbearing potential (WOCBP) will be included with measures to prevent accidental exposure to IMP by using double barrier contraception and pregnancy test prior to injection.
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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
-
Centre Hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, H2X 3E4, Canada
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a new drug shrink nasal polyps and restore smell?
- Triple-Action nasal spray could ease chronic sinusitis
- 3D-Printed nose models could boost sinus rinse results
- Sinus surgery may ease sleep problems in nasal polyp patients
- Real-World check: do new biologics really help severe nasal polyps?