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

  • STATUS
    Recruiting
  • End date
    Apr 5, 2026
  • participants needed
    1000
  • sponsor
    Sanofi
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Updated on 5 October 2020
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Investigator
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Primary Contact
Investigational site number 2500001 (1.1 mi away) Contact
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atopy
eczema
dupilumab

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 adult AD patients in a real-world setting
  • To assess comorbid atopic conditions and effects of treatment in comorbid atopic conditions in adult patients who receive Dupixent for AD
  • To collect safety data on study participants

Description

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

Details
Treatment Dupilumab SAR231893 (REGN668)
Clinical Study IdentifierNCT03992417
SponsorSanofi
Last Modified on5 October 2020

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Eligibility

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Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: ATOPIC DERMATITIS or Eczema (Atopic Dermatitis) or Dermatitis, Atopic or Dermatite Atopique or Eczéma (Dermatite Atopique)?
Initiating treatment with Dupixent for AD according to the country-specific prescribing information. Note: Participants may be eligible if they have already initiated treatment with Dupixent for AD within 6 months before their enrollment in the registry, provided that all core baseline data required (Eczema Area and Severity Index [EASI], Scoring of Atopic Dermatitis [SCORAD], body surface area [of AD involvement] [BSA], Patient-Oriented Eczema Measure [POEM], and Dermatology Life Quality Index [DLQI]) by the registry protocol were captured at the time of initiating Dupixent treatment and are available for entry in the registry database
Able to understand and complete study-related questionnaires
Provide signed informed consent

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
The above information is not intended to contain all considerations relevant
to a patient's potential participation in a clinical trial
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Step 2 Get screened

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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Step 3 Enroll in the clinical study

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Step 4 Get your study results

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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