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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Regeneron Pharmaceuticals
Study ID
NCT05203380
Status
Completed

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

First listed
Jan 24, 2022
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)

FacilityCityStateZIPSite coordinators
Clinical Research Center of Alabama, LLCBirminghamAlabama35209-
Arizona Allergy & Immunology ResearchGilbertArizona85234-
Pediatric Skin Research, LLCCoral GablesFlorida33146-
Skin Research of South Florida, LLCMiamiFlorida33173-
Skin Care Physicians of GeorgiaMaconGeorgia31217-
Ann & Robert H. Lurie Children's Hospital of ChicagoChicagoIllinois60611-
DermAssociates, LLCRockvilleMaryland20850-
National Allergy and Asthma Research, LLCNorth CharlestonSouth Carolina29420-
Texas Dermatology and Laser SpecialistsSan AntonioTexas78218-
Virginia Clinical Research, Inc.NorfolkVirginia23502-

Find similar trials in Birmingham, AL

By research site
Clinical Research Center of Alabama, LLC· Birmingham, ALArizona Allergy & Immunology Research· Gilbert, AZPediatric Skin Research, LLC· Coral Gables, FLSkin Research of South Florida, LLC· Miami, FLSkin Care Physicians of Georgia· Macon, GAAnn & Robert H. Lurie Children's Hospital of Chicago· Chicago, IL

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