Status:
ACTIVE_NOT_RECRUITING
Study of Patients Receiving DUPIXENT® for Atopic Dermatitis (AD)
Lead Sponsor:
Regeneron Pharmaceuticals
Collaborating Sponsors:
Sanofi
Conditions:
Dermatitis, Atopic
Eligibility:
All Genders
12+ years
Brief Summary
A long-term observational registry in patients with atopic dermatitis (AD) initiating treatment with DUPIXENT® (dupilumab)
Detailed 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 d...
Eligibility Criteria
Inclusion
- Key
- 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.
- Key
Exclusion
- 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.
Key Trial Info
Start Date :
April 6 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 30 2027
Estimated Enrollment :
858 Patients enrolled
Trial Details
Trial ID
NCT03428646
Start Date
April 6 2018
End Date
March 30 2027
Last Update
December 29 2025
Active Locations (99)
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1
Regeneron Investigational Site
Birmingham, Alabama, United States, 35205
2
Regeneron Investigational Site
Gilbert, Arizona, United States, 85234
3
Regeneron Investigational Site
Fountain Valley, California, United States, 92708
4
Regeneron Investigational Site
Laguna Hills, California, United States, 92653