Neuropsychologic Assessments of Dupilumab-Treated Adolescent Participants With Moderate-to-Severe Atopic Dermatitis
NCT05203380 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 45
Last updated 2023-09-08
Summary
Primary Objective: Part A
* To quantify deficits in cognitive functioning in adolescents with moderate-to-severe AD, using the Conners' Continuous Performance Test 3rd Edition (CPT-3) d' T-score
* To determine the entry criterion (CPT-3 d' score) for Part B
Primary Objective: Part B
* To measure changes in cognitive functioning in adolescents with moderate-to-severe AD treated with dupilumab
Secondary Objectives
* To evaluate the relationship of cognitive and sensory functioning with severity of AD in adolescent AD patients
* To evaluate the relationship between changes in AD severity and changes in cognitive and sensory functioning scores following treatment with dupilumab (Part B only).
Conditions
Interventions
- DRUG
-
Weight based dosing for 16 weeks in accordance of United States prescribing information (USPI)
Sponsors & Collaborators
- collaborator INDUSTRY
- lead INDUSTRY
Principal Investigators
-
Clinical Trial Management · Regeneron Pharmaceuticals
Eligibility
- Min Age
- 12 Years
- Max Age
- 17 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-01-27
- Primary Completion
- 2023-03-10
- Completion
- 2023-03-10
- FDA Drug
- Yes
Countries
- United States
Study Locations
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