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

NCT06169527 | Active Not Recruiting FDA Drug

• 2 other identifiers: OBS17668U1111-1279-3469
• Study Type: observational
• Target: 303
• Locations: 1 country
• Sites: 42

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

Outcome Measures

Primary Outcomes (26)

• Demographic characteristics of participants who receive dupilumab for AD

  Including age, gender, educational level, socio-professional category

  At baseline

• Weight characteristics of participants who receive dupilumab for AD

  At baseline

• Height characteristics of participants who receive dupilumab for AD

  At baseline

• Medical history characteristics of participants who receive dupilumab for AD

  including previous treatments for AD, relevant medical history, family history of atopy

  At baseline

• Comorbidities and treatments change from baseline

  At baseline, month 3, month 6, month 12, month 18, month 24, month 30, month 36

• Atopic comorbidities and treatments change from baseline

  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

  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

  At baseline, month 3, month 6, month 12, month 18, month 24, month 30, month 36

• Change from baseline in dupilumab administration

  At baseline, month 3, month 6, month 12, month 18, month 24, month 30, month 36

• Change from baseline in dupilumab compliance with treatment

  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

  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

  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

  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)

  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)

  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)

  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 itch assessment

  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 sleep disturbance NRS

  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)

  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)

  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)

  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 Dermatitis Family Impact Questionnaire (DFI)

  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)

  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

• Change in Work Productivity and Activity Impairment Questionnaire, Atopic Dermatitis (WPAI-AD)

  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)

  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

  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

Study Arms (1)

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

Interventions

Dupilumab DRUG

Dupilumab cohort

Also known as: SAR231893, Dupixent®

Participants with AD treated with dupilumab

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead
• Regeneron Pharmaceuticals: collaborator

Study Sites (42)

Investigational Site Number: 2500041

Amiens, 80054, France

Location

Investigational Site Number: 2500037

Angers, 49000, France

Location

Investigational Site Number: 2500021

Argenteuil, 95107, France

Location

Investigational Site Number: 2500044

Armentières, 59280, France

Location

Investigational Site Number: 2500018

Arras, 62000, France

Location

Investigational Site Number: 2500011

Ars-Laquenexy, 57530, France

Location

Investigational Site Number: 2500023

Avignon, 84000, France

Location

Investigational Site Number: 2500001

Besançon, 25000, France

Location

Investigational Site Number: 2500003

Bron, 69500, France

Location

Investigational Site Number: 2500043

Caen, 14033, France

Location

Investigational Site Number: 2500050

Chambéry, 73000, France

Location

Investigational Site Number: 2500006

Clermont-Ferrand, 63113, France

Location

Investigational Site Number: 2500005

Dijon, 21231, France

Location

Investigational Site Number: 2500004

Epagny Metz Tessy, 74370, France

Location

Investigational Site Number: 2500039

Fort-de-France, 97261, France

Location

Investigational Site Number: 2500045

La Tronche, 38700, France

Location

Investigational Site Number: 2500019

Le Havre, 76083, France

Location

Investigational Site Number: 2500040

Le Mans, 72037, France

Location

Investigational Site Number: 2500038

Les Sables-d'Olonne, 85100, France

Location

Investigational Site Number: 2500048

Levallois-Perret, 92300, France

Location

Investigational Site Number: 2500032

Lille, 59037, France

Location

Investigational Site Number: 2500002

Limoges, 87000, France

Location

Investigational Site Number: 2500036

Lorient, 56100, France

Location

Investigational Site Number: 2500029

Marseille, 13008, France

Location

Investigational Site Number: 2500028

Montpellier, 34090, France

Location

Investigational Site Number: 2500024

Nantes, 44093, France

Location

Investigational Site Number: 2500025

Nice, 06000, France

Location

Investigational Site Number: 2500020

Nice, 6300, France

Location

Investigational Site Number: 2500016

Pau, 64000, France

Location

Investigational Site Number: 2500009

Périgueux, 24019, France

Location

Investigational Site Number: 2500042

Poitiers, 86000, France

Location

Investigational Site Number: 2500022

Pontoise, 95300, France

Location

Investigational Site Number: 2500014

Romans-sur-Isère, 26102, France

Location

Investigational Site Number: 2500008

Rouen, 76031, France

Location

Investigational Site Number: 2500015

Saint-Germain-en-Laye, 78100, France

Location

Investigational Site Number: 2500027

Saint-Mandé, 94163, France

Location

Investigational Site Number: 2500026

Saint-Nazaire, 44606, France

Location

Investigational Site Number: 2500035

Saint-Pierre, 97410, France

Location

Investigational Site Number: 2500013

Saint-Pierre, 97448, France

Location

Investigational Site Number: 2500012

Toulouse, 31059, France

Location

Investigational Site Number: 2500010

Valence, 26000, France

Location

Investigational Site Number: 2500031

Vandœuvre-lès-Nancy, 54500, France

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

dupilumab

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2023
• First Posted: December 13, 2023
• Study Start: November 28, 2023
• Primary Completion (Estimated): May 10, 2028
• Study Completion (Estimated): May 10, 2028
• Last Updated: July 14, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share

Locations

FR (42)