A Long-term Data Collection Study of Participants in France Aged 6 Years Old or More With Atopic Dermatitis Receiving Dupilumab

NCT ID: NCT06169527

Last Updated: 2025-07-14

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 303 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-11-28
• Study Completion Date: 2028-05-10

Brief Summary

This is a long-term study to collect data over 3 years in order to find out what is likely to happen in the future regarding participants 6 years of age and older who receive dupilumab for Atopic Dermatitis (AD) commonly known as Eczema, and to characterize real-world effectiveness, safety and use patterns of dupilumab in real world setting in France. Patients will be invited to participate if initiating treatment with dupilumab for AD according to French-specific prescribing information. The decision of initiation of the treatment is independent to the study's participation. The study will be conducted in approximately 50 centers in France to evaluate a representative sample of patients treated in France. At each participating site, all AD participants who receive an initial prescription for dupilumab will be invited to participate in this study, until the enrollment goal is achieved.

Conditions

Atopic Dermatitis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Participants with AD treated with dupilumab

Patients ≥6 years of age in whom dupilumab therapy was initiated to treat their AD according to French-specific prescribing information.

Dupilumab

Intervention Type: DRUG

Dupilumab cohort

Interventions

Dupilumab

Dupilumab cohort

Intervention Type: DRUG

Other Intervention Names

SAR231893; Dupixent®

Eligibility Criteria

Inclusion Criteria

• Male or female, 6 years or older.
• Initiating treatment with dupilumab for AD according to French-specific prescribing information (≥ 12 years old: moderate to severe AD versus 6-11 years old: severe AD). The decision of initiation of the treatment is independent to the study's participation.
• Able to understand and complete study-related questionnaires.
• Signed informed consent form. For participants <18 years old, Informed consent form signed by the parent/legal guardian and participant's assent obtained.

Exclusion Criteria

• Patients who have a contraindication to the drug according to the French-specific prescribing information label.
• Any condition that, in the opinion of the Investigator, may interfere with patient's ability to participate in the study, such as short life expectancy, substance abuse, severe cognitive impairment, or other comorbidities that can predictably prevent the patient from adequately completing, as per routine care, the schedule of visits and assessments.
• Patients currently participating in any interventional clinical trial.
• Patients previously treated with dupilumab.
• Patients under tutorship or curatorship; patients under safeguard of justice or deprived of his/her liberty by an administrative or court decision.

• Minimum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Investigational Site Number: 2500041

Amiens, , France

Investigational Site Number: 2500037

Angers, , France

Investigational Site Number: 2500021

Argenteuil, , France

Investigational Site Number: 2500044

Armentières, , France

Investigational Site Number: 2500018

Arras, , France

Investigational Site Number: 2500011

Ars-Laquenexy, , France

Investigational Site Number: 2500023

Avignon, , France

Investigational Site Number: 2500001

Besançon, , France

Investigational Site Number: 2500003

Bron, , France

Investigational Site Number: 2500043

Caen, , France

Investigational Site Number: 2500050

Chambéry, , France

Investigational Site Number: 2500006

Clermont-Ferrand, , France

Investigational Site Number: 2500005

Dijon, , France

Investigational Site Number: 2500004

Epagny Metz Tessy, , France

Investigational Site Number: 2500039

Fort-de-France, , France

Investigational Site Number: 2500045

La Tronche, , France

Investigational Site Number: 2500019

Le Havre, , France

Investigational Site Number: 2500040

Le Mans, , France

Investigational Site Number: 2500038

Les Sables-d'Olonne, , France

Investigational Site Number: 2500048

Levallois-Perret, , France

Investigational Site Number: 2500032

Lille, , France

Investigational Site Number: 2500002

Limoges, , France

Investigational Site Number: 2500036

Lorient, , France

Investigational Site Number: 2500029

Marseille, , France

Investigational Site Number: 2500028

Montpellier, , France

Investigational Site Number: 2500024

Nantes, , France

Investigational Site Number: 2500025

Nice, , France

Investigational Site Number: 2500020

Nice, , France

Investigational Site Number: 2500016

Pau, , France

Investigational Site Number: 2500009

Périgueux, , France

Investigational Site Number: 2500042

Poitiers, , France

Investigational Site Number: 2500022

Pontoise, , France

Investigational Site Number: 2500014

Romans-sur-Isère, , France

Investigational Site Number: 2500008

Rouen, , France

Investigational Site Number: 2500015

Saint-Germain-en-Laye, , France

Investigational Site Number: 2500027

Saint-Mandé, , France

Investigational Site Number: 2500026

Saint-Nazaire, , France

Investigational Site Number: 2500035

Saint-Pierre, , France

Investigational Site Number: 2500013

Saint-Pierre, , France

Investigational Site Number: 2500012

Toulouse, , France

Investigational Site Number: 2500010

Valence, , France

Investigational Site Number: 2500031

Vandœuvre-lès-Nancy, , France

Countries

France

Other Identifiers

U1111-1279-3469

Identifier Type: REGISTRY

Identifier Source: secondary_id

OBS17668

Identifier Type: -

Identifier Source: org_study_id