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

Conditions

• Moderate-to-severe Atopic Dermatitis

Eligibility Criteria

Sex

ALL

Age

12 Years - 17 Years

Healthy Volunteers

Not accepted

Interventions

• dupilumab — DRUG
  Weight based dosing for 16 weeks in accordance of United States prescribing information (USPI)

Study Details

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).

Key Dates

Start date

Jan 27, 2022

Status verified

Aug 2023

Primary completion

Mar 10, 2023

Completion

Mar 10, 2023

Study Design

Enrollment

45 participants (actual)

Arms

• Arm: Part A
  Assessed in a single visit and no study-related treatment will be given.
• Arm: Part B
  Patients in Part A may also enroll in Part B provided they meet the eligibility criteria.

Primary Outcome Measure

Proportion of AD patients with a Conner's CPT-3 d' T-score ≥ 60 [ Time Frame: Day 1 ]

Locations (10)

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