NCT06169527Active, not recruiting
A Long-term Data Collection Study of Participants in France Aged 6 Years Old or More With Atopic Dermatitis Receiving Dupilumab
French Prospective Observational Study of Patients Receiving Dupilumab for Atopic Dermatitis.
Source: ClinicalTrials.gov · Last updated 14 Jul 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 303 (actual)
- First submitted
- 5 Dec 2023
- Start date
- 28 Nov 2023
- Primary completion date
- 10 May 2028
- Lead sponsor
- Sanofi
- Diseases
- Atopic dermatitis (eczema)
- NCT number
- NCT06169527
What you commit to
- Study type: Observational
- Participants enrolled: 303
- From 28 Nov 2023 to the primary completion date, 10 May 2028
- 42 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who have a contraindication to the drug according to the French-specific prescribing information label.
- Patients previously treated with dupilumab.
Other illness
- 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.
Other
- Patients currently participating in any interventional clinical trial.
- Patients under tutorship or curatorship; patients under safeguard of justice or deprived of his/her liberty by an administrative or court decision.
Who the study is looking for
- 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.
Age in the registry: 6 years to - · Sex: All · Does not accept healthy volunteers
Sites (42)
Sites in registry order. Save your city in your profile to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.