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Observational Study of Patients Receiving Dupixent® for Atopic Dermatitis (AD) | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITING

Observational Study of Patients Receiving Dupixent® for Atopic Dermatitis (AD)

A Prospective Observational Study of Patients Receiving Dupixent® for Atopic Dermatitis

NCT03992417•Sanofi

Summary

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: * To characterize real-world use patterns of Dupixent® for AD (eg, used regimens, reason for initiation of new treatments, concomitant therapies, treatment durations and reasons for discontinuation and/or switching) * To assess the long-term effectiveness of Dupixent® in AD patients in a real-world setting * To assess comorbid atopic conditions and effects of treatment in comorbid atopic conditions in patients who receive Dupixent® for AD * To collect safety data on study participants

Detailed Description

Participants enrolled in the study will be followed for 5 years.

Eligibility

Age

12 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male or female, 12 years or older at the baseline visit. Note: Adolescent participants (at least 12 years old, but less than 18 years) are eligible only after Dupixent® receives the respective country's regulatory approval for use in this age group;
•Able to understand and complete study-related questionnaires
•Provide signed informed consent or parental/legally acceptable representative consent and/or patient assent where applicable

Exclusion Criteria

•Participants 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 participant patient from adequately completing the schedule of visits and assessments
•Patients currently participating in any interventional clinical trial which modifies patient care
•Prior use of Dupixent® within 6 months of the screening visit, or within 6 months of the baseline visit if screening and baseline occur on the same day
•The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Locations (114)

Investigational Site Number : 0320013

Pilar, Buenos Aires, Argentina

Investigational Site Number : 0320012

Rosario, Santa Fe Province, Argentina

Investigational Site Number : 0320011

Ciudad Autonoma Bs As, Argentina

Investigational Site Number : 0360002

Kogarah, New South Wales, Australia

Investigational Site Number : 0360005

Kogarah, New South Wales, Australia

Investigational Site Number : 0360003

Woolloongabba, Queensland, Australia

Investigational Site Number : 0360004

Bedford Park, South Australia, Australia

Investigational Site Number : 0360001

Carlton, Victoria, Australia

Investigational Site Number : 0400005

Graz, Austria

Investigational Site Number : 0400004

Linz, Austria

Key Dates

Start Date

June 11, 2019

Primary Completion Date

March 31, 2027

Completion Date

March 31, 2027

Last Updated

July 11, 2025

Enrollment

955

ACTUAL participants

Conditions

Dermatitis Atopic

Interventions

Dupilumab SAR231893 (REGN668)

DRUG

Open Label, Long-term Study Evaluating Safety and Efficacy of Subcutaneous Amlitelimab in Participants Aged 12 Years and Older With Moderate to Severe Atopic Dermatitis

NCT05769777

Dermatitis Atopic

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ACTIVE_NOT_RECRUITING

Observational Evaluation of Atopic Dermatitis in Pediatric Patients

NCT03687359

Dermatitis Atopic

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ACTIVE_NOT_RECRUITINGPHASE4

A Study of Long-term Effect of Dupilumab on Skin Barrier Function in Pediatric Participants With Atopic Dermatitis

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 11, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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