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Active Not Recruiting
NCT03428646
Study of Patients Receiving DUPIXENT® for Atopic Dermatitis (AD)
Conditions: Dermatitis, Atopic
Sex: All
Ages: 12 Years – N/A
Healthy volunteers: No
Enrollment: 858
Sponsor: Regeneron Pharmaceuticals
Location: Regeneron Investigational Site Birmingham Alabama
Summary
A long-term observational registry in patients with atopic dermatitis (AD) initiating treatment with DUPIXENT® (dupilumab)
Eligibility Criteria
Key Inclusion Criteria:
* 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 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.
Source: ClinicalTrials.gov (NCT03428646). StuddyBuddy aggregates publicly available trial information.