Mepolizumab with or without in-office nasal polypectomy for chronic rhinosinusitis with nasal polyps

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter randomized trial compares three approaches in adults with chronic rhinosinusitis with nasal polyps who meet EPOS 2020 criteria for biologic therapy. Participants receive 100 mg subcutaneous mepolizumab every 4 weeks for 12 doses, in addition to topical corticosteroids. The three arms are: mepolizumab plus in-office nasal polypectomy, mepolizumab alone, and in-office nasal polypectomy alone. Primary endpoints focus on symptom burden and disease control, assessed through questionnaires and nasal endoscopy across five visits over roughly 30 minutes per participant. Eligibility requires adults with CRSwNP, evidence of type 2 inflammation, and an indication for biologic treatment.

Why it matters

Who can join: the full rules

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

Where it's running

• 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, Spain Recruiting
• Hospital Universitario Virgen Macarena
  Seville, Spain Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Tezepelumab for Chinese adults with nasal polyps: a 24-week treatment study

  This trial tests whether tezepelumab can improve nasal polyps and symptoms in Chinese adults with chronic rhinosinusitis with nasal polyps who are starting therapy.

  Recruiting at 34 sites Phase 3 AstraZeneca · Beijing and 33 other locations · NCT07520162

• Stopping mepolizumab or dupilumab to see if nasal polyps stay in complete remission.

  This trial will test whether adults with well-controlled nasal polyps who have been on mepolizumab or dupilumab can safely stop the biologic and remain symptom-free.

  Recruiting at 6 sites Phase 4 Copenhagen University Hospital, Rigshospitalet · Copenhagen, Region H and 5 other locations · NCT07268313

• Reducing how often biologic injections are given for chronic nasal polyps

  This study will test whether spacing out mepolizumab or dupilumab injections to every 6–8 weeks keeps symptoms controlled in adults with partly controlled chronic rhinosinusitis with nasal polyps.

  Recruiting at 3 sites Phase 4 Copenhagen University Hospital, Rigshospitalet · Aalborg and 8 other locations · NCT07187583

• Sinonasal microbiome transplant for chronic rhinosinusitis

  This will try a sinonasal microbiome transplant to see if it reduces symptoms in people with chronic rhinosinusitis with or without nasal polyps.

  Recruiting Phase 2/3 Region Skane · Helsingborg · NCT07184684

• SHR-1905 injection for chronic rhinosinusitis with nasal polyps

  This trial will test whether SHR-1905 injections help adults with chronic rhinosinusitis with nasal polyps reduce polyp size and symptoms compared with placebo.

  Recruiting Phase 3 Guangdong Hengrui Pharmaceutical Co., Ltd · Shanghai, Shanghai Municipality · NCT07132827

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.