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Can a biologic drug plus office polyp removal beat either alone for stubborn nasal polyps?

NCT ID NCT07814924

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 11, 2026 · Last updated Sep 11, 2026

Summary

Researchers are testing three approaches for adults with chronic rhinosinusitis and nasal polyps that keep coming back. One group receives mepolizumab injections every four weeks, another has polyps removed in the office, and a third has both the procedure and the drug. The trial measures changes in symptom scores and polyp size over a year to see which approach works best.

What this could mean

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

Active substance
mepolizumab, a biologic drug given by injection, tested alone and alongside an in-office nasal polyp removal procedure
What this could lead to
If the combination works best, doctors could offer people with recurring nasal polyps a way to remove polyps and control inflammation at the same time, possibly reducing the need for repeat surgeries.
What could go wrong
The trial is relatively small and compares three approaches, so differences between them may be hard to pin down. Mepolizumab can cause injection reactions or other side effects, and in-office polypectomy carries risks like bleeding or discomfort.

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 75 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2024

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 to 80 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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Participant 18 years of age or older 2. Patients with a diagnosis of CRS with polyposis according to the criteria of the EPOS2020 guideline: Chronic rhinosinusitis with nasal polyps in adults is defined as presence of two or more symptoms, one of which should be either nasal blockage / obstruction / congestion or nasal discharge (anterior / posterior nasal drip); ± facial pain/pressure; ± reduction or loss of smell; for ≥12 weeks; and either endoscopic signs of nasal polyps, and/or CT changes: mucosal changes within the ostiomeatal complex and/or sinuses. 3. Patients with indication for biologic treatment according to the criteria of the EPOS2020 guideline. Presence of bilateral polyps in a patient who had ESS and three of the following criteria are required: 3.1. Evidence of type 2 inflammation (tissue eos\> 10/hpf\* or blood eos\>250, OR total IgE\> 100). \* Whenever possible histology from previous surgery should be reviewed to confirm if eosinophilic pathology. If the previous surgery was performed more than 2 years earlier, a blood eosinophil count is essential, as the previous biopsy data may not be relevant. 3.2. Need for systemic corticosteroids or contraindication to systemic steroids (≥ 2 courses per yr, OR long term (\>3 months) 3.3. Significantly impaired quality of life (SNOT ≥ 40) 3.4. Significant loss of smell (≥7 VAS) 3.5. Diagnosis of comorbid asthma 4. Basal eosinophil count (BEC) ≥300 cells/µL for surgical naïve patients- or for those who have had surgery and have recurrence . The result of a previous analysis would be valid if it was obtained in a period of time not exceeding one year 5. Patients have been informed and signed consent to participate in the study. Exclusion Criteria: 1. Any serious or uncontrolled systemic or psychiatric illness that prevents a correct cognitive or endoscopic assessment or does not advise participation in the study. 2. Unilateral localized secondary CRS (odontogenic, fungal ball, tumor). 3. Bilateral diffuse secondary CRS (cystic fibrosis; eosinophilic granulomatosis with polyangiitis-S. de Churg-Strauss-; granulomatosis with polyangiitis-S de Wegener-; primary ciliary dyskinesia; selective immunodeficiencies. 4. Pregnancy/ breast feeding. 5. Hypersensitivity to mepolizumab or its excipients. 6. Patients unable to complete the questionnaire or follow prescribed treatment. 7. Patients who are participating in another clinical trial related to polyposis or asthma. 8. Previously documented failure with IL-5/IL-5 receptor biologics

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As listed by the trial registrant

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    7 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Hospital Puerta del Hierro

    RECRUITING

    Madrid, Spain

  • Hospital Universitario Virgen Macarena

    RECRUITING

    Seville, Spain

  • Hospital de Cruces

    RECRUITING

    Barakaldo, Spain

  • Hospital de Jerez

    RECRUITING

    Jerez de la Frontera, Spain

  • Hospital de Salamanca

    RECRUITING

    Salamanca, Spain

  • Hospital de Valladolid

    RECRUITING

    Valladolid, Spain

  • Hospital universitario Marques de Valdecilla

    RECRUITING

    Santander, 39006, Spain

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