An observational study in Dermatitis Atopic, sponsored by Sanofi. Active, not recruiting at 105 sites in 22 countries. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2026-08-06.
Sponsored by Sanofi · Observational
Primary Objective:
To characterize the patients who receive Dupixent® (dupilumab) for AD in a real-world setting, with respect to their medical history, socio-demographic and disease characteristics, and prior and concomitant treatments of AD
Secondary Objectives:
Participants enrolled in the study will be followed for 5 years.
1,591 studies on the registry are indexed under Dermatitis, Atopic; 286 are open to participants now.
This study's enrollment of 955 is above the median of 150 across 282 observational studies indexed under Dermatitis, Atopic.
Browse Dermatitis, Atopic studies →Sanofi is the lead sponsor of 1,557 studies on the registry; 91 are open to participants now.
Of its 205 completed or terminated interventional studies of FDA-regulated products, 123 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
The target population is adult and adolescent patients (male or female, ≥12 years old), who are initiating treatment with Dupixent® for AD according to the country-specific prescribing information.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adult and adolescent participants with AD initiating treatment with Dupixent® for AD according to the country-specific prescribing information, as part of their usual care as determined by their physician
Drug: Dupilumab SAR231893 (REGN668)
Pharmaceutical form: solution for injection Route of administration: subcutaneous injection
Also known as: Dupixent®
Baseline Characteristics: Medical history
Time frame: Baseline to Month 60
Baseline Characteristics: Socio-demographics
Time frame: Baseline to Month 60
Baseline Characteristics: Disease characteristics
Time frame: Baseline to Month 60
Physician Assessment: Body Surface Area Affected (BSA) by Atopic Dermatitis
Percentage of BSA affected by AD assessed for each major section of the body
Time frame: Baseline to Month 60
Physician Assessment: Eczema Area and Severity Index (EASI)
Measure used in clinical practice and clinical trials to assess the severity and extent of AD
Time frame: Baseline to Month 60
Physician Assessment: Scoring of Atopic Dermatitis (SCORAD)
Measure used in clinical practice and clinical trials to standardize the evaluation of the severity and extent of AD
Time frame: Baseline to Month 60
Participant Assessment: Patient Oriented Eczema Measure (POEM)
Questionnaire used in clinical practice and clinical trials to assess disease symptoms in children and adults
Time frame: Baseline to Month 60
Participant Assessment: Pruritus Numerical Rating Scale (NRS)
Individual NRS used to rate the intensity of pruritus using a 0 to 10 numeric rating scale
Time frame: Baseline to Month 60
Participant Assessment: Skin Pain or Soreness NRS
Individual NRS used to rate skin pain and soreness using a 0 to 10 NRS
Time frame: Baseline to Month 60
Participant Assessment: Skin Feeling Hot NRS
Individual NRS used to rate the sensation of skin feeling hot (burning sensation) using a 0 to 10 NRS
Time frame: Baseline to Month 60
Participant Assessment: Skin Sensitivity NRS
Individual NRS used to rate skin sensitivity using a 0 to 10 NRS
Time frame: Baseline to Month 60
Participant Assessment: Sleep Disturbance NRS
Individual NRS used to report the severity of their sleep disturbance using a 0 to 10 NRS
Time frame: Baseline to Month 60
Participant Assessment: Dermatology Life Quality Index (DLQI) for adults and Children Dermatology Life Quality Index (CDLQI) for adolescents
Questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on quality of life (QOL)
Time frame: Baseline to Month 60
Participant Assessment: Juniper Asthma Control Questionnaire (ACQ-5)
Questionnaire to evaluate asthma control in participants with comorbid asthma
Time frame: Baseline to Month 60
Participant Assessment: Allergic Rhinitis-Visual Analog Scale (AR-VAS)
Instrument for the documentation of symptoms and therapy monitoring in allergic rhinitis
Time frame: Baseline to Month 60
Participant Assessment: Work Productivity and Activity Impairment Questionnaire for AD (WPAI-AD) for adults and Work Productivity and Activity Impairment Questionnaire+Classroom Impairment Questions for AD (WPAI-CIQ-AD) for adolescents
Questionnaire to assess the impact of AD on productivity
Time frame: Baseline to Month 60
Participant Assessment: Health Care Resource Utilization Questionnaire
Questionnaire regarding hospitalization, or emergency room/urgent care center visits due to AD
Time frame: Baseline to Month 60
Participant Assessment: 9-Item Treatment Satisfaction Questionnaire for Medication (TSQM-9)
Instrument to measure treatment satisfaction
Time frame: Baseline to Month 60
Adverse events (AEs)
Number of participants with at least 1 AE
Time frame: Baseline to Month 60
Participant Assessment: Atopic Dermatitis Control Tool (ADCT) to be collected optionally
Questionnaire related with Atopic dermatitis control
Time frame: Baseline to Month 60
Showing the first 100 of 105 sites across 22 countries. Choose a country and city above to see the rest.
Plan to share: 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
This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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