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Study in Adults With Severe Chronic Rhinosinusitis With Nasal Polyposis Treated With Dupilumab in France

NCT ID: NCT06393946

Last Updated: 2025-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-10-20

Study Completion Date

2026-07-31

Brief Summary

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This is a multicentre, non-interventional, single arm study that aims to describe the treatment patterns in France: patients' characteristics, disease characteristics, prior treatments for Severe chronic rhinosinusitis with nasal polyposis and treatment prescription modalities. As well as to assess the clinical outcome after initiation of dupilumab (Dupixent®) and safety of the product during the two years of treatment

Detailed Description

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Conditions

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Chronic Rhinosinusitis With Nasal Polyposis

Keywords

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Real World Evidence (RWE) ENT disease CRSwNP Nasal Polyp Syndrome Dupixent Surgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Dupilumab

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Dupilumab

Intervention Type DRUG

This study will not administer any treatment, only observe the treatment as prescribed in real world-clinical practice.

Interventions

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Dupilumab

This study will not administer any treatment, only observe the treatment as prescribed in real world-clinical practice.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patient aged \>= 18 years old at the time of the initiation of the treatment with dupilumab (Dupixent®).
* Decision to initiate Dupixent® prior to inclusion in the study, initiation of Dupixent® for severe Chronic rhinosinusitis with nasal polyposis (CRSwNP) maximum 3 months before inclusion.
* Informed consent and willingness to participate.

Exclusion Criteria

* Conditions or legal situations resulting in impossibility to consent or impacting the interpretation of the results.
* Patient participating in an interventional clinical trial with experimental product at inclusion.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role collaborator

Sanofi

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

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Investigational Site Number: 250.0001

Nantes, , France

Site Status

Countries

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Reunion France

Other Identifiers

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OBS17269

Identifier Type: -

Identifier Source: org_study_id

U1111-1264-3068

Identifier Type: REGISTRY

Identifier Source: secondary_id