Mepolizumab and in Office-office Nasal Polypectomy in Patients With Chronic Rhinosinusitis (CRS). (MELYSA)

September 10, 2026 updated by: Instituto de Investigación Marqués de Valdecilla

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

This randomized, controlled multicenter trial will recruit patients aged 18 to 70 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 ifferent 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Patients with chronic rhinosinusitis with nasal polyps (CRSwNP) and indication for biologic treatment according to the criteria of the EPOS2020 guideline.

Presence of bilateral polyps in a patient who had endoscopic sinus surgery (ESS) (except in cases where the patient is not fit for surgery) and three of the following criteria are required:

  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.

  2. Need for systemic corticosteroids or contraindication to systemic steroids (≥ 2 courses per yr, OR long term (>3 months)
  3. Significantly impaired quality of life (SNOT ≥ 40)
  4. Significant loss of smell (VAS).
  5. Diagnosis of comorbid asthma

Study Type

Interventional

Enrollment (Estimated)

75

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barakaldo, Spain
      • Jerez de la Frontera, Spain
        • Recruiting
        • Hospital de Jerez
        • Contact:
      • Madrid, Spain
        • Recruiting
        • Hospital Puerta del Hierro
        • Contact:
      • Salamanca, Spain
      • Santander, Spain, 39006
        • Recruiting
        • Hospital Universitario Marques de Valdecilla
        • Contact:
      • Seville, Spain
      • Valladolid, Spain
        • Recruiting
        • Hospital de Valladolid
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: surgical arm
This group of patients will undergo nasal polypectomy in the office and will not receive mepolizumab treatment.
Procedure: surgical arm
polypectomy in the office and will not receive mepolizumab treatment.
Experimental: medical arm
This group of patients will not undergo in-office nasal polypectomy and will start treatment with mepolizumab directly after randomization.
Drug: Mepolizumab 100 MG
will not undergo in-office nasal polypectomy and will start treatment with mepolizumab directly after randomization.
Experimental: combined arm
This group of patients will undergo in-office nasal polypectomy before starting treatment with mepolizumab. Mepolizumab treatment will be administered at the surgical procedure visit or within 48 hours after the polypectomy.
Other: combined arm
in-office nasal polypectomy before starting treatment with mepolizumab. Mepolizumab treatment will be administered at the surgical procedure visit or within 48 hours after the polypectomy.
Other Names:
  • polypeptomy + mepolizumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the efficacy of mepolizumab+polypectomy compared to mepolizumab or polypectomy, using the change from baseline in sinonasal outcome test (SNOT-22) total score at week 52.
Time Frame: 12 moths
SNOT-22 total score ranges from 0 to 110, with higher scores indicating worse quality of life/more severe symptoms.
12 moths

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in nasal polyposis severity VAS score at V1, V6, V12.
Time Frame: 1 month, 6 months and 12 months
VAS score ranges from 0 to 100, with higher scores indicating greater symptom severity.
1 month, 6 months and 12 months
Change in endoscopic nasal polyp score at V1, V6, V12
Time Frame: 1 month, 6 months and 12 months
1 month, 6 months and 12 months
Improvement in individual VAS symptoms (rhinorrhea, mucus in throat, nasal blockage, and sense of smell), patient-reported outcomes at V1, V6, V12
Time Frame: 1 month, 6 months and 12 months
1 month, 6 months and 12 months
Number of patients no longer requiring rescue systemic corticosteroid treatment throughout the first year after the first month of starting the study
Time Frame: 12 months
12 months
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) Related to Mepolizumab and/or In-office Nasal Polypectomy
Time Frame: 1 month, 2 months, 4 months, 6 months, 8 months, 10 months and 12 months
Adverse events collected at each study visit and classified as serious or non-serious per protocol definitions, and by causal relationship to treatment (unrelated, possible, probable) as assessed by the investigator.
1 month, 2 months, 4 months, 6 months, 8 months, 10 months and 12 months
Change from baseline in sinonasal outcome test (SNOT-22) total score at weeks 4 and 24
Time Frame: 1 month and 12 months
1 month and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto de Investigación Marqués de Valdecilla

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 31, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

September 19, 2025

First Submitted That Met QC Criteria

September 10, 2026

First Posted (Actual)

September 11, 2026

Study Record Updates

Last Update Posted (Actual)

September 11, 2026

Last Update Submitted That Met QC Criteria

September 10, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MELYSA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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