Biologics for Chronic Rhinosinusitis with Nasal Polyps in France
Official title: Real Life Assessment of Biologics Efficacy in Severe Chronic Rhinosinusitis With Nasal Polyps
Run by University Hospital, Lille · NCT06501807 · Data updated 2026-11-12
This registry follows adults with CRSwNP who are being treated with biologics (dupilumab, mepolizumab, or benralizumab) to see how these therapies work in real-world clinical practice.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 900 (estimated) |
| Sponsor | University Hospital, Lille Academic / other |
| Drugs / interventions | omalizumab, mepolizumab, benralizumab, dupilumab |
| Locations | 2 sites (Lille and 1 other locations) |
| Status | Recruiting |
| Started | July 11, 2024 |
| Main results expected | September 2, 2034 |
| Study ends | January 2, 2035 |
| Registry record updated | May 18, 2026 |
| Trial ID | NCT06501807 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults over 18 with CRSwNP who require a biologic treatment per current approvals.
✕Probably not a fit
Patients who do not respond to biologics or who have contraindications or are not eligible under standard approval criteria.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This French registry collects data on adults with chronic rhinosinusitis with nasal polyps who require biologic therapy. It tracks real-world outcomes from treatments already approved for CRSwNP, focusing on clinical and biological data since August 2021. The study aims to understand endotype-based patient responses and how biomarkers relate to treatment effectiveness, with retrospective data complemented by prospective follow-up. No randomized interventions are introduced; treatment decisions follow standard clinical practice under existing approvals.
Why it matters
Potential benefit: If successful, the registry could clarify which patients benefit most from each biologic and help tailor endotype-driven treatment choices.
How similar studies have gone: Other real-world registries have shown useful insights into biologic responses in CRSwNP, supporting the value of this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients of over 18-year old requiring a biologic treatment for CRswNP in accordance with its marketing approval. * The patients already treated according to this criteria since August 2021 will be followed and their previous clinical and biological data retrospectively collected Exclusion Criteria: * Oral corticotherapy in the previous month; * Biologic treatment with anti-IgE (omalizumab), anti-IL-5/IL-5R (mepolizumab, benralizumab) or anti-IL-4/IL-13R (dupilumab) or any other biotherapy for inflammatory diseases in the previous 6 months of initiation of treatment apart from ongoing biotherapies for severe asthma or CRSwNP; * Hypersensitivity to humanized antibodies ; * Documented SARS-Cov2 infection in the last 3 months with persistent olfactory disorders related to COVID; * Pregnant or breast-feeding women; * Patient without social coverage.
Where it's running
-
chu de Lille
Lille, France Recruiting -
CHU de Lille
Lille, France Active not recruiting
Study contacts
- Study coordinator: Geoffrey Mortuaire, MD, pHD
- Email: geoffrey.mortuaire@chru-lille.fr
- Phone: 0320445675
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Metabolic and Immunologic Biomarkers in Chronic Rhinosinusitis with Nasal Polyps
This study tests whether metabolic and immune markers in nasal tissue and blood differ between people with nasal polyps and those without, to help understand CRSwNP and find potential diagnostic clues.
-
GSK5784283 as add-on therapy for chronic rhinosinusitis with nasal polyps
This study tests whether GSK5784283 added to standard care can help adults with chronic rhinosinusitis with nasal polyps feel better and have fewer symptoms.
-
GSK5784283 as add-on maintenance therapy for nasal polyps in chronic rhinosinusitis
This study tests whether adding GSK5784283 (Felcorekibart) to standard care helps people with chronic rhinosinusitis with nasal polyps.
-
Triamcinolone-loaded nanocapsules after endoscopic nasal surgery
This trial tests whether a triamcinolone acetonide–loaded nanocapsule spray is better than saline irrigation for healing after endoscopic nasal surgery in adults with chronic rhinosinusitis and nasal polyps.
-
Depemokimab monotherapy for chronic rhinosinusitis with nasal polyps in Japanese adults
This study tests depemokimab alone (without intranasal corticosteroids) in adults with chronic rhinosinusitis with nasal polyps in Japan.
-
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.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.