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

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NCT06169527 · readout in 629 d

Sponsored by Sanofi (industry) · SNY — their whole pipeline →. With Regeneron Pharmaceuticals.

Phase

—

Status

Active, not recruiting

Study type

Observational

Enrollment

303actual

Sites

Country

France

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Dates

each axis at the precision it was filed, with the registry's own basis

Date

Filed

Basis

What it is

Start

2023-11-28

actual

When the study began enrolling

Primary completion

2028-05-10

estimated

The date the last participant is measured for the primary outcome — the readout window

Study completion

2028-05-10

estimated

The whole study's end, after follow-up

First posted

2023-12-13

actual

When this record first appeared on the registry

Results posted

—

When the sponsor posted results to the registry

Record updated

2025-07-14

actual

The sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Condition

Atopic Dermatitis

Intervention

Drug: Dupilumab — also filed as SAR231893, Dupixent®

Primary outcomes

what the primary-completion date above is the date OF

Demographic characteristics of participants who receive dupilumab for AD

measured At baseline

Weight characteristics of participants who receive dupilumab for AD

measured At baseline

Height characteristics of participants who receive dupilumab for AD

measured At baseline

Medical history characteristics of participants who receive dupilumab for AD

measured At baseline

Comorbidities and treatments change from baseline

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

Atopic comorbidities and treatments change from baseline

measured 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

measured At baseline, month 3, month 6, month 12, month 18, month 24, month 30, month 36 if applicable

Change from baseline in dupilumab dose

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

Change from baseline in dupilumab administration

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

Change from baseline in dupilumab compliance with treatment

measured 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

measured 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

measured 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

measured 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)

measured 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)

measured 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)

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

Change in itch assessment

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

Change in sleep disturbance NRS

measured 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)

measured 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)

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

Change in Dermatology Life Quality Index (DLQI)

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

Change in Dermatitis Family Impact Questionnaire (DFI)

measured 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)

measured 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)

measured At month 6, month 12, month 18, month 24, month 30, month 36

Number of Adverse Events (AE)

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

Change from baseline in Drug Survival

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

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