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Active, not recruitingNCT05923047MELYSAUpdated Nov 10, 2026

Mepolizumab and In-office Nasal Polypectomy in Patients With Chronic Rhinosinusitis (CRS). A Three Arm Study.

A Phase 4 interventional study of Mepolizumab and Polypeptomy in Rhinosinusitis Chronic and Polyp, Nasal, sponsored by Instituto de Investigación Marqués de Valdecilla. Active, not recruiting at 7 sites in Spain. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-11-10.

Sponsored by Instituto de Investigación Marqués de Valdecilla · Phase 4, Interventional, and Treatment

Updated Nov 10, 2026Now Active, not recruitingStart date moved+4 moreGo to Updates ↓
Phase
Phase 4
Study type
Interventional
Enrollment
75
Allocation
Randomized
Ages
18 Years to 100 Years
Sex
All
01

Study summary

This randomized, controlled multicenter trial will recruit patients aged 18 to 70 7 years with recurrent nasal polyposis requiring surgery and indication for biologic treatment according to EPOS 2020 guideline. Patients in the Mepolizumab arms will receive 100 mg of subcutaneous mepolizumab every 4 weeks for a total of 12 doses in addition to daily topical corticosteroid treatment.

All study procedures will be performed in five study visits and may take approximately 30 minutes. Clinical assessments include different questionnaires and nasal endoscopy. This trial includes three treatment arms.

  1. Combined group (In-office nasal polypectomy group with mepolizumab): This group will undergone in-office nasal polypectomy and will receive Mepolizumab.
  2. Medical group (mepolizumab): This group will receive Mepolizumab.
  3. Surgical group (In-office nasal polypectomy): This group will undergone in-office nasal polypectomy. The main advantage is that it allows comparison of mepolizumab versus surgery and surgery/mepolizumab versus surgery + mepolizumab, providing more information on the most effective therapeutic approach.

The presence of adverse effects will be assessed in each treatment arm.

02

Conditions studied

  • Rhinosinusitis Chronic
  • Polyp, Nasal

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03

In context

Nasal Polyps

236 studies on the registry are indexed under Nasal Polyps; 68 are open to participants now.

This study's planned enrollment of 75 is above the median of 60 across 181 interventional studies indexed under Nasal Polyps.

Browse Nasal Polyps studies →

Lead sponsor

Instituto de Investigación Marqués de Valdecilla is the lead sponsor of 33 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Participant 18 years of age or older
  • 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.

  • Patients with indication for biologic treatment according to the criteria of the EPOS2020 guideline. Presence of bilateral polyps in a patient who had ESS (except in cases where the patient is not fit for surgery, see bellow) and three of the following criteria are required:
  • Evidence of type 2 inflammation (tissue eos> 10/hpf* or blood eos>250, OR total IgE> 100).
  • Need for systemic or to systemic steroids (≥ 2 courses per yr, OR long term (>3 months)
  • Significantly impaired quality of life (SNOT ≥ 40)
  • Significant loss of smell (≥7 VAS)
  • Diagnosis of comorbid asthma
  • Basal eosinophil count (BEC) ≥300 cells/μL for surgical naïve patients- only those not fit for surgery (major criteria) or for those who have had surgery and have recurrence (minor criteria).
  • Patients have been informed and signed consent to participate in the study.
  • For those patients not suitable for surgery, the criteria of the EUFOREA guidelines for indication of biological treatment will be used (4 criteria, one of them being ≥300 cells/μL BEC).

Exclusion criteria

Exclusion Criteria:

  • Any serious or uncontrolled systemic or psychiatric illness that prevents a correct cognitive or endoscopic assessment or does not advise participation in the study.
  • Unilateral localized secondary CRS (odontogenic, fungal ball, tumor).
  • 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.
  • Pregnancy/ breast feeding
  • to mepolizumab or it's
  • Patients unable to complete the questionnaire or follow prescribed treatment.
  • Patients who are participating in another clinical trial related to polyposis or asthma.
  • Previously documented failure with IL-5/IL-5 receptor biologics
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
75 participants (estimated)

Study arms

  • Experimental
    Combined group

    In-office nasal polypectomy group with mepolizumab

    Drug: Mepolizumab · Procedure: Polypeptomy

  • Experimental
    Medical group

    (mepolizumab)

    Drug: Mepolizumab

  • Active comparator
    Surgical group

    In-office nasal polypectomy

    Procedure: Polypeptomy

Interventions

  • DrugMepolizumab

    Patients in the Mepolizumab arms will receive 100 mg of subcutaneous mepolizumab every 4 weeks for a total of 12 doses in addition to daily topical corticosteroid treatment

  • ProcedurePolypeptomy

    This group will undergone in-office nasal polypectomy.

06

What researchers measure

Primary outcomes

  1. Mepolizumab+polypectomy compared to mepolizumab or polypectomy, using the change from baseline in sinonasal outcome test (SNOT-22) total score

    Time frame: up to 52 weeks

Secondary outcomes

  1. Change in nasal polyposis severity VAS score at 4 weeks, 6 months, 12 months

    Time frame: up to 52 weeks

  2. Change in endoscopic nasal polyp score at 4 weeks, 6 months, 12 months

    Time frame: up to 52 weeks

  3. Improvement in individual VAS symptoms (rhinorrhea, mucus in throat, nasal blockage, and sense of smell), patient-reported outcomes at 4 weeks, 6 months, 12 months

    Time frame: up to 52 weeks

  4. Number of patients no longer requiring rescue systemic corticosteroid treatment throughout the first year after the first month of starting the study

    Time frame: up to 52 weeks

  5. Number of participants with mepolizumab and in-office nasal polypectomy related adverse events

    Time frame: up to 52 weeks

  6. Change from baseline in sinonasal outcome test

    The minimum value is 0 and maximum value is 110

    Time frame: up to 4 and 24 week

07

Study locations

7 sites
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it moved

Started Nov 2023 (actual). Primary completion is estimated for Jan 2027, 38 months after the start.

Since we started tracking on Sep 25, 2026, the dates moved once, on Nov 10, 2026: start Sep 2023 → Nov 2023, primary completion Sep 2024 → Jan 2027 and completion Dec 2024 → Jan 2027.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Jun 1, 2023
First posted
Jun 28, 2023
StartActual
Nov 1, 2023was Sep 2023
Primary completionEst.
Jan 1, 2027was Sep 2024
CompletionEst.
Jan 1, 2027was Dec 2024
Last update
Nov 10, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Not yet recruiting→Active, not recruiting
changed Nov 10, 2026
Sites
3 sites added, 3 sites removed
Show 3 added (3 Spain)
  • Hospital Universitario Marques de Valdecilla · Santander, Spain
  • Hospital de Jerez · Jerez de la Frontera, Spain
  • Hospital Virgen Macarena · Seville, Spain
Show 3 removed
  • Hospital de Jerez · Jerez De La Frontera, Spain
  • Hospital Universitario Marques de Valdecilla · Santander, Spain
  • Hospital Virgen Macarena · Sevilla, Spain
Nov 10, 2026
Start date
Sep 1, 2023→Nov 1, 2023 (actual)
Nov 10, 2026
Primary completion
Sep 1, 2024→Jan 1, 2027
Nov 10, 2026
Study completion
Dec 1, 2024→Jan 1, 2027
Nov 10, 2026
Show all 1 update
  1. Nov 10, 2026
    Not yet recruiting→Active, not recruiting
    3 sites added, 3 sites removed
    Show 3 added (3 Spain)
    • Hospital Universitario Marques de Valdecilla · Santander, Spain
    • Hospital de Jerez · Jerez de la Frontera, Spain
    • Hospital Virgen Macarena · Seville, Spain
    Show 3 removed
    • Hospital de Jerez · Jerez De La Frontera, Spain
    • Hospital Universitario Marques de Valdecilla · Santander, Spain
    • Hospital Virgen Macarena · Sevilla, Spain
    Start date Sep 1, 2023→Nov 1, 2023 (now actual)
    Primary completion Sep 1, 2024→Jan 1, 2027
    Study completion Dec 1, 2024→Jan 1, 2027
    + 3 other changes: verification date, arm descriptions and contact details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT05923047
Lead sponsor
Instituto de Investigación Marqués de Valdecilla
Responsible party
Sponsor
First posted
Jun 28, 2023
Start date
Nov 1, 2023
Primary completion
Jan 1, 2027 (estimated)
Completion
Jan 1, 2027 (estimated)
Last update
Nov 10, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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