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

NCT07814924 | Recruiting Phase 4

• 1 other identifier: MELYSA
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 7

Brief Summary

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. 1.Combined group (In-office nasal polypectomy group with mepolizumab): This group will undergone in-office nasal polypectomy and will receive Mepolizumab.
2. 2.Medical group (mepolizumab): This group will receive Mepolizumab.
3. 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.

Conditions

Chronic Rhinosinusitis With Nasal Polyps

Keywords

mepolizumab; polypeptomy; in office nasal

Outcome Measures

Primary Outcomes (1)

• 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.

  SNOT-22 total score ranges from 0 to 110, with higher scores indicating worse quality of life/more severe symptoms.

  12 moths

Secondary Outcomes (6)

• Change in nasal polyposis severity VAS score at V1, V6, V12.

  1 month, 6 months and 12 months

• Change in endoscopic nasal polyp score at V1, V6, V12

  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

  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

  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

  1 month, 2 months, 4 months, 6 months, 8 months, 10 months and 12 months

Study Arms (3)

surgical arm

ACTIVE COMPARATOR

This group of patients will undergo nasal polypectomy in the office and will not receive mepolizumab treatment.

Procedure: surgical arm

medical arm

EXPERIMENTAL

This group of patients will not undergo in-office nasal polypectomy and will start treatment with mepolizumab directly after randomization.

Drug: Mepolizumab 100 MG

combined arm

EXPERIMENTAL

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

Interventions

surgical arm PROCEDURE

polypectomy in the office and will not receive mepolizumab treatment.

surgical arm

Mepolizumab 100 MG DRUG

will not undergo in-office nasal polypectomy and will start treatment with mepolizumab directly after randomization.

medical arm

combined arm OTHER

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.

Also known as: polypeptomy + mepolizumab

combined arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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).
• \* 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.
• Need for systemic corticosteroids or contraindication 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- 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
• Patients have been informed and signed consent to participate in the study.

You may not qualify if:

• 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.
• Hypersensitivity to mepolizumab or its excipients.
• 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

Sponsors & Collaborators

• Instituto de Investigación Marqués de Valdecilla: lead

Study Sites (7)

Hospital de Cruces

Barakaldo, Spain

RECRUITING

Hospital de Jerez

Jerez de la Frontera, Spain

RECRUITING

Hospital Puerta del Hierro

Madrid, Spain

RECRUITING

Hospital de Salamanca

Salamanca, Spain

RECRUITING

Hospital universitario Marques de Valdecilla

Santander, 39006, Spain

RECRUITING

Hospital Universitario Virgen Macarena

Seville, Spain

RECRUITING

Hospital de Valladolid

Valladolid, Spain

RECRUITING

MeSH Terms

Interventions

mepolizumab

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2025
• First Posted: September 11, 2026
• Study Start: December 31, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 11, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (7)