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

July 11, 2025 updated by: Sanofi

French Prospective Observational Study of Patients Receiving Dupilumab for Atopic Dermatitis.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
303

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Trial Transparency email recommended (Toll free for US & Canada)
  • Phone Number: option 6 800-633-1610
  • Email: Contact-US@sanofi.com

Study Locations

  • France
      • Amiens, France, 80054
        • Investigational Site Number: 2500041
      • Angers, France, 49000
        • Investigational Site Number: 2500037
      • Argenteuil, France, 95107
        • Investigational Site Number: 2500021
      • Armentières, France, 59280
        • Investigational Site Number: 2500044
      • Arras, France, 62000
        • Investigational Site Number: 2500018
      • Ars Laquenexy, France, 57530
        • Investigational Site Number: 2500011
      • Avignon, France, 84000
        • Investigational Site Number: 2500023
      • Besançon, France, 25000
        • Investigational Site Number: 2500001
      • Bron, France, 69500
        • Investigational Site Number: 2500003
      • Caen, France, 14033
        • Investigational Site Number: 2500043
      • Chambery, France, 73000
        • Investigational Site Number: 2500050
      • Clermont Ferrand, France, 63113
        • Investigational Site Number: 2500006
      • Dijon, France, 21231
        • Investigational Site Number: 2500005
      • Epagny Metz Tessy, France, 74370
        • Investigational Site Number: 2500004
      • Fort-de-France, France, 97261
        • Investigational Site Number: 2500039
      • La Tronche, France, 38700
        • Investigational Site Number: 2500045
      • Le Havre, France, 76083
        • Investigational Site Number: 2500019
      • Le Mans, France, 72037
        • Investigational Site Number: 2500040
      • Les Sables d'Olonne, France, 85100
        • Investigational Site Number: 2500038
      • Levallois-Perret, France, 92300
        • Investigational Site Number: 2500048
      • Lille, France, 59037
        • Investigational Site Number: 2500032
      • Limoges, France, 87000
        • Investigational Site Number: 2500002
      • Lorient, France, 56100
        • Investigational Site Number: 2500036
      • Marseille, France, 13008
        • Investigational Site Number: 2500029
      • Montpellier, France, 34090
        • Investigational Site Number: 2500028
      • Nantes, France, 44093
        • Investigational Site Number: 2500024
      • Nice, France, 06000
        • Investigational Site Number: 2500025
      • Nice, France, 6300
        • Investigational Site Number: 2500020
      • Pau, France, 64000
        • Investigational Site Number: 2500016
      • Poitiers, France, 86000
        • Investigational Site Number: 2500042
      • Pontoise, France, 95300
        • Investigational Site Number: 2500022
      • Périgueux, France, 24019
        • Investigational Site Number: 2500009
      • Romans sur Isère, France, 26102
        • Investigational Site Number: 2500014
      • Rouen, France, 76031
        • Investigational Site Number: 2500008
      • Saint Germain en Laye, France, 78100
        • Investigational Site Number: 2500015
      • Saint Mandé, France, 94163
        • Investigational Site Number: 2500027
      • Saint Nazaire, France, 44606
        • Investigational Site Number: 2500026
      • Saint-Pierre, France, 97410
        • Investigational Site Number: 2500035
      • Saint-Pierre, France, 97448
        • Investigational Site Number: 2500013
      • Toulouse, France, 31059
        • Investigational Site Number: 2500012
      • Valence, France, 26000
        • Investigational Site Number: 2500010
      • Vandoeuvre-lès-Nancy, France, 54500
        • Investigational Site Number: 2500031

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

The population of interest for this study will be patients in France aged 6 years old or more with a diagnosis of AD either severe or moderate to severe (depending on age group) who initiate dupilumab in real world setting. The study will be conducted in real conditions of practice, dupilumab will be prescribed at the sole initiative of the participating physician irrespective of patient enrolment decision.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Drug: Dupilumab
Dupilumab cohort
Other Names:
  • SAR231893
  • Dupixent®

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Demographic characteristics of participants who receive dupilumab for AD
Time Frame: At baseline
Including age, gender, educational level, socio-professional category
At baseline
Weight characteristics of participants who receive dupilumab for AD
Time Frame: At baseline
At baseline
Height characteristics of participants who receive dupilumab for AD
Time Frame: At baseline
At baseline
Medical history characteristics of participants who receive dupilumab for AD
Time Frame: At baseline
including previous treatments for AD, relevant medical history, family history of atopy
At baseline
Comorbidities and treatments change from baseline
Time Frame: At baseline, month 3, month 6, month 12, month 18, month 24, month 30, month 36
At baseline, month 3, month 6, month 12, month 18, month 24, month 30, month 36
Atopic comorbidities and treatments change from baseline
Time Frame: At baseline, month 3, month 6, month 12, month 18, month 24, month 30, month 36
At baseline, month 3, month 6, month 12, month 18, month 24, month 30, month 36
Change from baseline in lifestyle habits of participants who receive dupilumab for AD
Time Frame: At baseline, month 3, month 6, month 12, month 18, month 24, month 30, month 36 if applicable
Including alcohol, tobacco, CBD and cannabis consumption
At baseline, month 3, month 6, month 12, month 18, month 24, month 30, month 36 if applicable
Change from baseline in dupilumab dose
Time Frame: At baseline, month 3, month 6, month 12, month 18, month 24, month 30, month 36
At baseline, month 3, month 6, month 12, month 18, month 24, month 30, month 36
Change from baseline in dupilumab administration
Time Frame: At baseline, month 3, month 6, month 12, month 18, month 24, month 30, month 36
At baseline, month 3, month 6, month 12, month 18, month 24, month 30, month 36
Change from baseline in dupilumab compliance with treatment
Time Frame: At baseline, month 3, month 6, month 12, month 18, month 24, month 30, month 36
At baseline, month 3, month 6, month 12, month 18, month 24, month 30, month 36
Change from baseline in dupilumab temporary or permanent discontinuation
Time Frame: At baseline, month 3, month 6, month 12, month 18, month 24, month 30, month 36
At baseline, month 3, month 6, month 12, month 18, month 24, month 30, month 36
Change from baseline in dupilumab treatment switch to another therapy
Time Frame: At baseline, month 3, month 6, month 12, month 18, month 24, month 30, month 36
At baseline, month 3, month 6, month 12, month 18, month 24, month 30, month 36
Change from baseline in dupilumab treatment for concomitant AD treatments
Time Frame: At baseline, month 3, month 6, month 12, month 18, month 24, month 30, month 36
At baseline, month 3, month 6, month 12, month 18, month 24, month 30, month 36
Change in patient's treatment satisfaction score using the Patient Global Assessment of Treatment Effect (PGATE)
Time Frame: At month 6, month 12, month 18, month 24, month 30, month 36
PGATE for patients ≥ 12 years of age: an internally developed and validated instrument allowing patients to rate their opinion and perceived treatment effect. Ratings are on a 5-point Likert scale from 1 being "Poor" and 5 being "Excellent".
At month 6, month 12, month 18, month 24, month 30, month 36
Change in eczema severity using the Eczema Area and Severity Index (EASI)
Time Frame: At baseline, month 6, month 12, month 18, month 24, month 30, month 36
EASI is a validated measure used to assess severity and extent of AD at each body region by multiplying the lesions characteristics score x the body area score x multiplier. Four AD disease characteristics -erythema, thickness (induration, population, and oedema), scratching (excoriation), and lichenification - will each be assessed for severity by the observing physician, as follows: 0 = none, absent; 1=mild (just perceptible); 2=Moderate (obvious); 3=Severe. The area score ranges from 0 to 6 is determined as follows: 0= 0% (no active eczema in region); 1= 1-9%; 2= 10-29%; 3= 30-49%; 4= 50-69%; 5= 70-89%; 6= 90-100% (entire region affected by eczema). The multiplier is determined according to the region affected and the age of the patient: 0.1 or 0.2 for patients < 8 years old (head/neck), 0.2 (upper limbs), 0.3 (trunk), 0.4 or 0.3 for patients < 8 years old (lower limbs). A higher score means higher AD severity. Scores range from 0 (no disease) to 72 (maximal disease severity).
At baseline, month 6, month 12, month 18, month 24, month 30, month 36
Change in AD disease control using the Atopic Dermatitis Control Tool (ADCT)
Time Frame: At baseline, month 6, month 12, month 18, month 24, month 30, month 36
ADCT for patients aged ≥ 12 years of age: a validated, brief and easily scored tool consisting of six concise questions allowing to rate the different dimensions of patient-perceived AD control, to foster communication between patients and their physicians and help appropriate decision-making. The instrument includes 6 items, with a 7-day recall period: overall severity of symptoms, frequency of intense episodes of itching, severity of bother, frequency of sleep impact, severity of daily activities impact and severity of mood or emotions impact. Each item is rated on a 5-point Likert scale, ranging from 0 (none/ not at all/ no nights) to 4 (very severe/ everyday/ extremely/ every night); the total score ranges from 0 to 24, which is the summation of the responses to all the items. A total score of ≥7 points was derived as the threshold to identify patients "not in control", based on optimal sensitivity/ specificity values. The higher the score, the less AD is controlled.
At baseline, month 6, month 12, month 18, month 24, month 30, month 36
Change in sleep disturbance NRS
Time Frame: At baseline, month 6, month 12, month 18, month 24, month 30, month 36
NRS sleep disturbance will be rated from 0 to 10 on average during the past 7 days (adult, pediatric and adolescent patients), completed by the observing physician after questioning of patient; 0 = "sleep not disturbed at all" (best possible sleep) and 10 = "sleep extremely disturbed (worst possible sleep)".
At baseline, month 6, month 12, month 18, month 24, month 30, month 36
Change in global patient's disease evaluation using the Patient Global Assessment of Disease Severity (PGADS)
Time Frame: At baseline, month 6, month 12, month 18, month 24, month 30, month 36
PGADS for patients ≥ 12 years of age: an internally developed and validated instrument allowing to the patients to rate their AD-related overall well-being. Patients will be asked: "Considering all the ways in which your eczema affects you, how well are you doing?" Response choices will be from 1 being "Poor" to 5 being "Excellent".
At baseline, month 6, month 12, month 18, month 24, month 30, month 36
Change in global patient's disease evaluation using the Caregiver Global Assessment of Disease (CGAD)
Time Frame: At baseline, month 6, month 12, month 18, month 24, month 30, month 36
CGAD for patients 6 to 11 years of age: an internally developed and validated instrument allowing to the caregivers to rate their child's AD-related overall well-being. Caregivers will be asked: "Considering all the way in which the eczema affects your child, how well is your child doing?". Response choices will be 1 being "Poor" to 5 being "Excellent".
At baseline, month 6, month 12, month 18, month 24, month 30, month 36
Change in Dermatology Life Quality Index (DLQI)
Time Frame: At baseline, month 6, month 12, month 18, month 24, month 30, month 36
DLQI for patients ≥ 16 years (or cDLQI for patients < 16 at baseline) are 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on quality of life in adults and pediatrics, respectively. The format is a simple response (0 to 3 where 0 is "not at all" and 3 is "very much") to 10 items, which assess quality of life over the past week, with an overall scoring system of 0 to 30; a high score is indicative of a poor quality of life. Patients 6-11 years old will be assisted for questionnaire completion. A cDLQI's cartoon version could be also used for patients from 6 to 11 years old. If a patient turns 16 years old during the study, they will switch to DLQI.
At baseline, month 6, month 12, month 18, month 24, month 30, month 36
Change in Work Productivity and Activity Impairment Questionnaire, Atopic Dermatitis (WPAI-AD)
Time Frame: At month 6, month 12, month 18, month 24, month 30, month 36
WPAI-AD for adults and WPAI-CIQ-AD for adolescents is a questionnaire designed to assess the impact of AD on the patient's productivity. The WPAI-AD is the version of the original generic WPAI that is specific to AD. It is a 6-item, validated questionnaire to measure impairments in work and activities over a 7-day recall period. The WPAI-AD outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity. If a patient turns 18 years old during the study, this one will switch to WPAI-AD.
At month 6, month 12, month 18, month 24, month 30, month 36
Number of Adverse Events (AE)
Time Frame: At baseline, month 3, month 6, month 12, month 18, month 24, month 30, month 36
AEs for dupilumab and/or concomitant treatments will be collected throughout the study.
At baseline, month 3, month 6, month 12, month 18, month 24, month 30, month 36
Change from baseline in Drug Survival
Time Frame: At baseline, month 3, month 6, month 12, month 18, month 24, month 30, month 36
Drug survival is defined as the time from the start of treatment to the end or discontinuation of treatment with no changes. If a patient has multiple drug survival events for the same treatment, the longest drug survival will be used in the data summarization. The drug survival will be illustrated using a Kaplan-Meier plot.
At baseline, month 3, month 6, month 12, month 18, month 24, month 30, month 36
Change in itch assessment
Time Frame: At baseline, month 6, month 12, month 18, month 24, month 30, month 36
Itch assessment (Worst-Itch Numeric Rating Scale, WI-NRS) will be rated from 0 to 10 on average during the past 7 days (adult, pediatric and adolescent patients), completed by the observing physician after questioning of patient; 0 = no itch and 10 = the worst imaginable itch.
At baseline, month 6, month 12, month 18, month 24, month 30, month 36
Change in Dermatitis Family Impact Questionnaire (DFI)
Time Frame: At baseline, month 6, month 12, month 18, month 24, month 30, month 36
DFI is a 10-item, validated questionnaire assessing the impact of AD on the QoL of the parents/legal representatives and family members of affected children. The format is a simple response (0 to 3 where 0 is "not at all" and 3 is "very much") to 10 items, which assess Quality of Life (QoL) over the past week, with an overall scoring system of 0 to 30; a high score is indicative of a poor QoL. It is designed to be completed by adults (aged 16 years or over) who have a child (up to and including the age of 15 years 11 months) in the family with atopic dermatitis.
At baseline, month 6, month 12, month 18, month 24, month 30, month 36
Change in European Quality of Life-5 Dimensions-3 level score (EQ-5D-3L)
Time Frame: At baseline, month 6, month 12, month 18, month 24, month 30, month 36

The EQ-5D-3L is completed by patients≥18 years old and by parent/legal representative of patients<18 years old. It consists of 2 parts:

  • The EQ-5D descriptive system has five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each has 3 levels: no problems, some problems, and extreme problems. The patient selects the most appropriate statement in each of the five dimensions, resulting in a 1-digit number for each dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
  • The EQ VAS records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'Best imaginable health state' and 'Worst imaginable health state'. The VAS can be used as a quantitative measure of health outcome that reflects the patient's own judgement. The scale is numbered 0 to 100. A higher value represents better health and a lower value represents worse health.
At baseline, month 6, month 12, month 18, month 24, month 30, month 36

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sanofi

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Regeneron Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 28, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 10, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 10, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 5, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 5, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 13, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 14, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 11, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • OBS17668 (Sanofi Identifier)
  • U1111-1279-3469 (Registry Identifier: ICTRP)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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