Brief Summary

A long-term observational registry in patients with atopic dermatitis (AD) initiating treatment with DUPIXENT® (dupilumab)

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

858

participants targeted

Target at P75+ for all trials

Timeline

11mo left

Started Apr 2018

Longer than P75 for all trials

Geographic Reach

2 countries

99 active sites

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

9 years study duration

Study Progress90%

Apr 2018Mar 2027

First Submitted

Initial submission to the registry

December 13, 2017

Completed

2 months until next milestone

First Posted

Study publicly available on registry

February 9, 2018

Completed

2 months until next milestone

Study Start

First participant enrolled

April 6, 2018

Completed

9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2027

Expected

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2027

Last Updated

December 29, 2025

Status Verified

December 1, 2025

Enrollment Period

9 years

First QC Date

December 13, 2017

Last Update Submit

December 22, 2025

Conditions

Dermatitis, Atopic

Keywords

Eczema

Outcome Measures

Primary Outcomes (2)

Registry Assessment: Baseline Characteristics
Medical history
At baseline (day when DUPIXENT treatment is initiated)
Registry Assessment: Baseline Characteristic
Socio-demographics
At baseline (day when DUPIXENT treatment is initiated)

Secondary Outcomes (20)

Registry (Physician) Assessment: Body Surface Area Affected (BSA) by Atopic Dermatitis
Baseline to month 60
Registry (Physician) Assessment: Eczema Area and Severity Index (EASI)
Baseline to month 60
Registry (Physician) Assessment: Overall Disease Severity scale
Baseline to month 60
Registry (Participant) Assessment: Patient Oriented Eczema Measure
Baseline to month 60
Registry (Participant) Assessment: Pruritus Numerical Rating Scales (NRS)
Baseline to month 60
+15 more secondary outcomes

Interventions

DupilumabDRUG

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

Eligibility Criteria

Age12 Years+

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

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.

You may qualify if:

Male or female, 12 years of age or older at the baseline visit. NOTE: Adolescent patients (at least 12 years old, but less than 18 years) are eligible in the US or Canada only after DUPIXENT receives the respective country's regulatory approval for use in this age group.
Initiating treatment with DUPIXENT® as standard-of-care for AD according to the country-specific prescribing information (Note: Participants will be screened when they received their initial prescription for DUPIXENT®).
Willing and able to comply with study-related activities.
Able to understand and complete study-related questionnaires.
Provide signed informed consent or parental/legal guardian consent plus patient assent, where applicable.

You may not qualify if:

Patients who have a contraindication to the drug according to the country-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 co-morbidities that can predictably prevent the patient from adequately completing the schedule of visits and assessments.
Prior use of dupilumab within 6 months of the screening visit, or within 6 months of the baseline visit if screening and baseline occur on the same day.

Contact the study team to confirm eligibility.