NCT05203380

Neuropsychologic Assessments of Dupilumab-Treated Adolescent Participants With Moderate-to-Severe Atopic Dermatitis

Neuropsychologic Assessments of Dupilumab-Treated Adolescents With Moderate-to-Severe Atopic Dermatitis

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 45 (actual)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 12 Years – 17 Years
• Healthy volunteers: Not accepted

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).

Detailed description

Per protocol Study Stop Criteria, study has concluded with Part A. Part B was not initiated and no data were collected.

Conditions

• Moderate-to-severe Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	dupilumab	Weight based dosing for 16 weeks in accordance of United States prescribing information (USPI)

Timeline

• Start date: 2022-01-27
• Primary completion: 2023-03-10
• Completion: 2023-03-10
• First posted: 2022-01-24
• Last updated: 2023-09-08

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated drug study