Study of Patients Receiving DUPIXENT for Atopic Dermatitis (AD)

  • STATUS
    Recruiting
  • End date
    Dec 31, 2025
  • participants needed
    1000
  • sponsor
    Regeneron Pharmaceuticals
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Updated on 29 July 2020
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Investigator
Clinical Trials Administrator
Primary Contact
Regeneron Investigational Site (9.3 mi away) Contact
+91 other location
atopy
dupilumab

Summary

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

Description

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

Details
Treatment Dupilumab
Clinical Study IdentifierNCT03428646
SponsorRegeneron Pharmaceuticals
Last Modified on29 July 2020

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Eligibility

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Inclusion Criteria

Is your age greater than or equal to 12 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)?
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

Exclusion Criteria

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
NOTE: Other protocol defined Inclusion/Exclusion criteria apply
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Step 3 Enroll in the clinical study

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Step 4 Get your study results

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