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

10 septembre 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

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

Type d'étude

Interventionnel

Inscription (Estimé)

75

Phase

  • Phase 4

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Espagne
      • Barakaldo, Espagne
        • Recrutement
        • Hospital De Cruces
        • Contact:
      • Jerez de la Frontera, Espagne
        • Recrutement
        • Hospital de Jerez
        • Contact:
      • Madrid, Espagne
        • Recrutement
        • Hospital Puerta del Hierro
        • Contact:
      • Salamanca, Espagne
      • Santander, Espagne, 39006
        • Recrutement
        • Hospital Universitario Marqués de Valdecilla
        • Contact:
      • Seville, Espagne
      • Valladolid, Espagne
        • Recrutement
        • Hospital de Valladolid
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La 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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur actif: surgical arm
This group of patients will undergo nasal polypectomy in the office and will not receive mepolizumab treatment.
Procédure: surgical arm
polypectomy in the office and will not receive mepolizumab treatment.
Expérimental: medical arm
This group of patients will not undergo in-office nasal polypectomy and will start treatment with mepolizumab directly after randomization.
Médicament: Mepolizumab 100 MG
will not undergo in-office nasal polypectomy and will start treatment with mepolizumab directly after randomization.
Expérimental: 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.
Autre: 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.
Autres noms:
  • polypeptomy + mepolizumab

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
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.
Délai: 12 moths
SNOT-22 total score ranges from 0 to 110, with higher scores indicating worse quality of life/more severe symptoms.
12 moths

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Change in nasal polyposis severity VAS score at V1, V6, V12.
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 1 month and 12 months
1 month and 12 months

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Instituto de Investigación Marqués de Valdecilla

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

31 décembre 2024

Achèvement primaire (Estimé)

31 décembre 2026

Achèvement de l'étude (Estimé)

31 décembre 2026

Dates d'inscription aux études

Première soumission

19 septembre 2025

Première soumission répondant aux critères de contrôle qualité

10 septembre 2026

Première publication (Réel)

11 septembre 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

11 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

10 septembre 2026

Dernière vérification

1 mai 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • MELYSA

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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