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NCT06107101
th2 Modulation CRSwNP
Phase 4 trial testing Mepolizumab in Chronic Rhinosinusitis With Nasal Polyps in 40 participants. Not yet recruiting.
1 January 2025
Quick facts
| Lead sponsor | St. Paul's Sinus Centre |
|---|---|
| Phase | Phase 4 |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | basic science |
| Enrollment | 40 |
| Start date | 1 June 2024 |
| Primary completion | 1 January 2025 |
| Estimated completion | 1 January 2025 |
| Sites | 1 location across Canada |
Drugs / interventions tested
- Mepolizumab (MEPOLIZUMAB) — full drug profile →
Conditions studied
- Chronic Rhinosinusitis With Nasal Polyps — all drugs for Chronic Rhinosinusitis With Nasal Polyps →
Sponsor
St. Paul's Sinus Centre
Who can join
19 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 (CRS) is a condition of persistent sinonasal mucosal inflammation which affects 11.9% of the US population. Mepolizumab is newly approved to treat chronic rhinosinusitis with nasal polyps (CRSwNP, the spaces inside nose and head are swollen and inflamed) and acts booking interleukin-5 (IL-5) a protein implicated in the inflammatory process. We aim to use Single-cell RNA sequencing (RNA-Seq, a method of genetically 'barcoding' cells to allow gene expression to be profiled at the level of individual cells) to study the effects of IL-5 blockade on the generation and maintenance of nasal adaptive immune responses, in CRS subjects.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06107101
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Mepolizumab
Trials testing the same drug.
- NCT07200336 — Anti-IL-5 Therapy With Simple Polypectomy Versus Extended Endoscopic Sinus Surgery for CRSwNP · Phase 4 · not yet recruiting
- NCT06041386 — REIMAGINE - Real World EvaluatIon of Mepolizumab in Severe Asthma achievinG on Treatment clinIcal remissioN, a prospEcti · Phase 4 · active not recruiting
- NCT05923047 — Mepolizumab and In-office Nasal Polypectomy in Patients With Chronic Rhinosinusitis (CRS). A Three Arm Study. · Phase 4 · unknown
- NCT05642806 — Comparison of Immune Profiles in Chronic Rhinosinusitis Patients After Mepolizumab Treatment · Phase 4 · recruiting
- NCT06348173 — Response and Remission to Treatment With Anti-IL5/IL5R Antagonists · completed
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 St. Paul's Sinus Centre trials
Trials by the same sponsor.
- NCT07528820 — Inflammatory Profiles, Histopathological Features, and Remodeling Factors in Chronic Rhinosinusitis With Nasal Polyps · NA · not yet recruiting
- NCT05642806 — Comparison of Immune Profiles in Chronic Rhinosinusitis Patients After Mepolizumab Treatment · Phase 4 · recruiting
- NCT04374448 — Utility of Indocyanine Green Fluorescence in Endoscopic Sinonasal and Skull Base Surgery · NA · unknown
- NCT04601324 — Allergic Rhinitis Combination Pharmacotherapy Efficacy Study · Phase 4 · withdrawn
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 NCT06107101 (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 St. Paul's Sinus Centre
- Last refreshed: 17 April 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/NCT06107101.
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