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NCT06258772: MEPOREAL
Mepolizumab in the Treatment of Patients With Severe Uncontrolled CRSwNP: a Multicentric Real Life Observational Study
trial testing Mepolizumab Auto-Injector in Chronic Rhinosinusitis With Nasal Polyps in 199 participants. Status unknown.
1 February 2025
Quick facts
| Lead sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 199 |
| Start date | 5 February 2024 |
| Primary completion | 1 February 2025 |
| Estimated completion | 1 February 2026 |
| Sites | 27 locations across Italy |
Drugs / interventions tested
- Mepolizumab Auto-Injector — full drug profile →
Conditions studied
- Chronic Rhinosinusitis With Nasal Polyps — all drugs for Chronic Rhinosinusitis With Nasal Polyps →
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Who can join
18 and older, any sex, with Chronic Rhinosinusitis With Nasal Polyps. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Chronic rhinosinusitis with nasal polyposis (CRSwNP) is a complex chronic inflammatory disease of the nasosinusal mucosa that has a significant negative impact on patients' quality of life. In CRSwNP, chronic inflammation is primarily driven by type 2 pro-inflammatory interleukins (ILs )such as IL-5, IL-4, and IL-13 along- side high levels of eosinophils in the surrounding tissue. Mepolizumab is a targeted, humanized anti-IL-5 antibody that prevents IL-5 from binding to its receptor on eosinophils and selectively inhibits eosinophilic inflammation. So far, randomized clinical trials have assessed efficacy and safety of Mepolizumab in a large number of patients, whereas evidences in real life clinical practice are limited to few monocentric series. Herewith, we present a multicenter, observational, prospective/retrospective nationwide real-life study with the aim to confirm the effectiveness and the safety of Mepolizumab over the first year of treatment in a real life setting. The primary objective of this study is to evaluate the reduction of dimension of nasal polyps and the improvement of quality of life in the patient measured through symptomatologic questionnaires. The secondary objective is to evaluate improvements in terms of smell dysfunction, comorbidities, biomarkers (nasal cytology and blood eosinophilia), need of surgery or systemic steroids.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06258772
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Related trials
Other recruiting trials for Chronic Rhinosinusitis With Nasal Polyps
Currently open trials in the same condition.
- NCT07187583 — Tapering of Biologics in Chronic Rhinosinusitis With Nasal Polyps · Phase 4 · recruiting
- NCT06914908 — Long-term Safety and Efficacy Evaluation of Lunsekimig in Adult Participants With Chronic Rhinosinusitis With Nasal Poly · Phase 2 · recruiting
- NCT06834347 — A Phase 3 Study to Assess the Efficacy, Safety, and Tolerability of Itepekimab (Anti-IL-33 mAb) in Participants With Ina · Phase 3 · recruiting
- NCT06834360 — A Phase 3 Study to Assess the Efficacy, Safety, and Tolerability of Itepekimab (Anti-IL-33 mAb) in Participants With Ina · Phase 3 · recruiting
- NCT06706817 — A Study to Investigate Changes in Symptoms in Adult Participants With Chronic Rhinosinusitis With Nasal Polyposis Initia · Phase 3 · recruiting
Other Fondazione Policlinico Universitario Agostino Gemelli IRCCS trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06258772 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Last refreshed: 14 February 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06258772.
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