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

Study at a glance

From the registry record, last updated by the sponsor on 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

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

ClinicalTrials.gov ID

NCT06169527

Acronym / sponsor ID

DUPILAB / OBS17668

Conditions

Atopic Dermatitis

Study type

Observational

Recruitment status

Active, not recruiting

Enrolment

303 participants (actual)

Lead sponsor

SanofiIndustry (pharma, biotech, devices)

Collaborators

Regeneron Pharmaceuticals

Study start

28 Nov 2023 (actual)

Primary completion

10 May 2028 (estimated)

Study completion

10 May 2028 (estimated)

First posted

13 Dec 2023 (actual)

Results

Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model

Cohort

Time perspective

Prospective

Number of arms

1

Who may qualify

Ages

6 years and older

Sex

All

Healthy volunteers

Not accepted

Age groups

Child, Adult, Older adult

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

1. Demographic characteristics of participants who receive dupilumab for AD

   Time frame: At baseline

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

2. Weight characteristics of participants who receive dupilumab for AD

   Time frame: At baseline

3. Height characteristics of participants who receive dupilumab for AD

   Time frame: At baseline

4. 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

5. Comorbidities and treatments change from baseline

   Time frame: At baseline, month 3, month 6, month 12, month 18, month 24, month 30, month 36

6. 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

7. 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

8. Change from baseline in dupilumab dose

   Time frame: At baseline, month 3, month 6, month 12, month 18, month 24, month 30, month 36

9. Change from baseline in dupilumab administration

   Time frame: At baseline, month 3, month 6, month 12, month 18, month 24, month 30, month 36

10. 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

11. 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

12. 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

13. 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

14. 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".

15. 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).

16. 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.

17. 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.

18. 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)".

19. 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".

20. 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".

21. 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.

22. 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.

23. 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.

24. 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.

25. 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.

26. 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.

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2025.
• Individual participant dataSharing planned: Yes. 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

Related trials for Atopic Dermatitis

• Not yet recruitingPhase 1

  A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants

  Atopic Dermatitis

• RecruitingObservational study

  Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research

  Cutaneous T-cell Lymphoma, Sezary Syndrome

• RecruitingPhase 1

  First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis

  Healthy Volunteer, Atopic Dermatitis

• Not yet recruitingPhase 1

  A Study of HSK60002 Tablets in Participants With Moderate-to-Severe Atopic Dermatitis

  Dermatitis Atopic

• RecruitingPhase 3

  A Study to Learn About the Study Medicine Called Tilrekimig in People With Moderate-to Severe Eczema

  Atopic Dermatitis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

42 sites in 1 country: see every site and its status.