An observational study in Dermatitis, Atopic, sponsored by Regeneron Pharmaceuticals. Active, not recruiting at 99 sites in 2 countries. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2025-12-29.
Sponsored by Regeneron Pharmaceuticals · Observational
A long-term observational registry in patients with atopic dermatitis (AD) initiating treatment with DUPIXENT® (dupilumab)
This is a prospective observational study conducted to (1) characterize the patients who receive DUPIXENT® 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; (2) characterize real world use patterns of DUPIXENT® for AD (eg, most commonly used regimens by line of therapy, reason for initiation of new treatments, concomitant therapies, treatment durations and reasons for discontinuation and/or switching); (3) assess the long-term effectiveness of DUPIXENT® in AD patients in a real world setting; (4) assess comorbid atopic conditions, patterns of use and effects of treatment in comorbid atopic conditions in patients who receive DUPIXENT® for AD; and (5) collect safety data on study participants
The target population comprises 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.
Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria apply.
Dupixent 1 dose at Baseline required for eligibility; otherwise, no therapeutic intervention required during the course of the study. In addition to (or substituting for) DUPIXENT®, participants may receive marketed drugs as deemed necessary by their physicians for the treatment of AD or comorbid conditions.
Also known as: DUPIXENT®, REGN668
Registry Assessment: Baseline Characteristics
Medical history
Time frame: At baseline (day when DUPIXENT treatment is initiated)
Registry Assessment: Baseline Characteristic
Socio-demographics
Time frame: At baseline (day when DUPIXENT treatment is initiated)
Registry (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
Registry (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
Registry (Physician) Assessment: Overall Disease Severity scale
Questionnaire used to characterizing the severity of AD on a 4-point scale (0=No disease, 1=Minimal disease, 2=Mild disease, 3=Moderate disease, 4=Severe disease)
Time frame: Baseline to month 60
Registry (Participant) Assessment: Patient Oriented Eczema Measure
Questionnaire used in clinical practice and clinical trials to assess disease symptoms in children and adults
Time frame: Baseline to month 60
Registry (Participant) Assessment: Pruritus Numerical Rating Scales (NRS)
Individual NRS used to rate the intensity of pruritus using a 0 to 10 numeric rating scale.
Time frame: Baseline to month 60
Registry (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
Registry (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
Registry (Participant) Assessment: Skin Sensitivity NRS
Individual NRS used to rate skin sensitivity using a 0 to 10 NRS
Time frame: Baseline to month 60
Registry (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
Registry (Participant) Assessment: Global Assessment of Atopic Dermatitis scale
Rate of overall well-being on a 5-point scale.
Time frame: Baseline to month 60
Registry (Participant) Assessment: Dermatology Life Quality Index (DLQI)
Questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on quality of life (QOL) in adults
Time frame: Baseline to month 60
Registry (Participant) Assessment: Children's Dermatology Life Quality Index (CDLQI)
Questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on QOL in pediatrics.
Time frame: Baseline to month 60
Registry (Participant) Assessment: Work Productivity and Activity Impairment Questionnaire for AD (WPAI-AD)
Questionnaire to assess the impact of AD on productivity.
Time frame: Baseline to month 60
Registry (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
Registry (Participant) Assessment: Dermatitis Family Impact Questionnaire
Questionnaire to assess the impact of atopic eczema on the QOL of the parents and family members of affected children.
Time frame: Baseline to month 60
Registry (Participant) Assessment: Missed School Days
Questionnaire to assess the number of missed school days since the last study assessment of adolescent patients (aged ≥ 12 to \< 18 years) who are enrolled in school.
Time frame: Baseline to month 60
Registry (Participant) Assessment: Juniper Asthma Control Questionnaire (ACQ-5)
5-question version of questionnaire to evaluate asthma control in registry patients with comorbid asthma.
Time frame: Baseline to month 60
Registry (Participant) Assessment: Allergic Rhinitis Visual Analog Scale (AR-VAS)
Questionnaire used as a validated measuring instrument for the documentation of symptoms and therapy monitoring in AR.
Time frame: Baseline to month 60
Registry (Participant) Assessment: Changes in Concurrent Conditions
Rate of change in any other condition(s) (other than eczema, asthma, and allergic symptoms) on a 2-point scale (Better or Worse).
Time frame: Baseline to month 60
Registry (Participant) Assessment: Overall Health State
Rate of overall state of health on a 5-point scale (Poor, Fair, Good, Very Good or Excellent).
Time frame: Baseline to month 60
This study is active, not recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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Regeneron Pharmaceuticals