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

NCT ID: NCT05203380

Last Updated: 2023-09-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 45 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-01-27
• Study Completion Date: 2023-03-10

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Part A

Assessed in a single visit and no study-related treatment will be given.

No interventions assigned to this group

Part B

Patients in Part A may also enroll in Part B provided they meet the eligibility criteria.

dupilumab

Intervention Type: DRUG

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

Interventions

dupilumab

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

Intervention Type: DRUG

Other Intervention Names

DUPIXENT®

Eligibility Criteria

Inclusion Criteria

1. Adolescent (12 - 17 years of age) Part A: at time of visit Part B: at time of screening visit

2. Diagnosis of atopic dermatitis (AD) according to American Academy of Dermatology consensus criteria; chronic AD Part A: first diagnosed at least 1 year prior to visit Part B: first diagnosed at least 1 year prior to the screening visit

3. EASI score ≥ 12 Part A: at time of visit Part B: at screening and baseline visits

4. IGA score ≥ 3 Part A: at time of visit Part B: at time of screening and baseline visits

5. Peak Pruritus NRS score ≥ 4 Part A: at time of visit Part B: at time of screening and baseline visits as defined in the protocol

6. The CPT-3 d' score for entry into Part B will be determined based on the distribution of the CPT-3 d' score from Part A

7. BSA of AD involvement ≥ 10% Part A: at time visit Part B: at screening and baseline visits

8. Part B Only: Documented recent history (within 6 months of the screening visit) of inadequate response (in the opinion of the investigator) to topical AD medication(s) or for whom topical AD medications are medically inadvisable as defined in the protocol

9. Part B Only: Patient's stable use of a prescription topical medication regimen for AD lesions for at least 2 weeks prior to baseline as defined in the protocol

Exclusion Criteria

1. Prior use of dupilumab Part A: within 6 months of visit Part B: within 6 months of screening

2. Skin diseases that could confound AD assessment as defined in the protocol

3. Treatment with methylphenidate, dexmethylphenidate, serdexmethylphenidate, amphetamine, dextroamphetamine, lisdexamfetamine, guanfacine, atomoxetine, clonidine, or viloxazine within 8 weeks or within 5 half-lives, whichever is longer, at visit

4. History of clinician-diagnosed attention-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, epilepsy, major depressive disorder, mania or bipolar disorder, or any Diagnostic and Statistical Manual-V (DSM-V) psychotic disorder, such as schizophrenia

5. Evidence of substance abuse, including alcohol and nicotine, in the past 2 years

6. Systemic antihistamine or nicotine use Part A: within the week prior to the visit Part B: during the week prior to screening

7. Part B Only: Active helminthic infections; suspected or high risk of helminthic infection, unless clinical and (if necessary) laboratory assessments have ruled out active infection before baseline

8. Part B Only: At baseline, presence of any conditions listed as criteria for study drug discontinuation

9. Part B Only: Treatment with high potency or super-potent TCS within 14 days prior to baseline

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: collaborator

Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trial Management

Role: STUDY_DIRECTOR

Regeneron Pharmaceuticals

Locations

Clinical Research Center of Alabama, LLC

Birmingham, Alabama, United States

Arizona Allergy & Immunology Research

Gilbert, Arizona, United States

Pediatric Skin Research, LLC

Coral Gables, Florida, United States

Skin Research of South Florida, LLC

Miami, Florida, United States

Skin Care Physicians of Georgia

Macon, Georgia, United States

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, United States

DermAssociates, LLC

Rockville, Maryland, United States

National Allergy and Asthma Research, LLC

North Charleston, South Carolina, United States

Texas Dermatology and Laser Specialists

San Antonio, Texas, United States

Virginia Clinical Research, Inc.

Norfolk, Virginia, United States

Countries

United States

References

Paller AS, Gonzalez ME, Barnum S, Jaeger J, Shao L, Ozturk ZE, Korotzer A. Attentiveness and mental health in adolescents with moderate-to-severe atopic dermatitis without ADHD. Arch Dermatol Res. 2024 Jul 30;316(8):497. doi: 10.1007/s00403-024-03210-x.

Reference Type: DERIVED

PMID: 39080094 (View on PubMed)

Other Identifiers

R668-AD-2024

Identifier Type: -

Identifier Source: org_study_id