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

NCT05203380 | Completed FDA Drug

• 1 other identifier: R668-AD-2024
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 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).

Conditions

Moderate-to-severe Atopic Dermatitis

Outcome Measures

Primary Outcomes (2)

• Proportion of AD patients with a Conner's CPT-3 d' T-score ≥ 60

  Part A Conners' Continuous Performance Test-3 (CPT-3): an objective test of attention and impulsivity that has been validated in individuals aged 8 years and older. The primary efficacy outcome measure (d' T-score) is a measure of "signal detectability" with respect to inattentiveness, that is, the respondent's ability to differentiate non-targets (ie, the letter X) from targets (ie, all other letters), and is calculated as: d' = z-score ("False Alarm") - z-score ("Hit"). "T scores" refer to a distribution of the d' statistic such that the mean is 50 and the standard deviation (SD) is 10. Lower d' T-score values indicate worse performance.

  Day 1

• Mean change from baseline in Conner's CPT-3 d' T-score

  Part B Conner's CPT-3 d' T-scoring as stated above.

  At week 16

Secondary Outcomes (41)

• Correlation of values for Conners' Continuous Performance Test 3rd Edition (CPT-3) scores (d' T-score, Commission Errors, Omission Errors, and Reaction Time) with AD disease severity based on Eczema Area and Severity Index (EASI)

  Day 1

• Correlation of values for Conners' CPT-3 scores with AD disease severity based on Body Surface Area (BSA)

  Day 1

• Correlation of values for Conners' CPT-3 scores with AD disease severity based on Peak Pruritus Numeric Rating Scale (NRS)

  Day 1

• Correlation of values for Conners' CPT-3 scores with AD disease severity based on Skin Pain Numeric Rating Scale (SP-NRS)

  Day 1

• Correlation of values for Conners' CPT-3 scores with AD disease severity based on Patient-Reported Outcomes Measurement Information System Pediatric Sleep Disturbance Questionnaire (PROMIS Pediatric Sleep Disturbance)

  Day 1

Study Arms (2)

Part A

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

Part B

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

Drug: dupilumab

Interventions

dupilumab DRUG

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

Also known as: DUPIXENT®

Part B

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Adolescents with moderate-to-severe atopic dermatitis (AD) will be assessed for quantifying deficits in cognitive functioning at a single visit only and no study-related treatment will be offered.

You may qualify if:

• Adolescent (12 - 17 years of age) Part A: at time of visit Part B: at time of screening visit
• 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
• EASI score ≥ 12 Part A: at time of visit Part B: at screening and baseline visits
• IGA score ≥ 3 Part A: at time of visit Part B: at time of screening and baseline visits
• 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
• 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
• BSA of AD involvement ≥ 10% Part A: at time visit Part B: at screening and baseline visits
• 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
• 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

You may not qualify if:

• Prior use of dupilumab Part A: within 6 months of visit Part B: within 6 months of screening
• Skin diseases that could confound AD assessment as defined in the protocol
• 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
• 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
• Evidence of substance abuse, including alcohol and nicotine, in the past 2 years
• Systemic antihistamine or nicotine use Part A: within the week prior to the visit Part B: during the week prior to screening
• 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
• Part B Only: At baseline, presence of any conditions listed as criteria for study drug discontinuation
• Part B Only: Treatment with high potency or super-potent TCS within 14 days prior to baseline

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead
• Sanofi: collaborator

Study Sites (10)

Clinical Research Center of Alabama, LLC

Birmingham, Alabama, 35209, United States

Location

Arizona Allergy & Immunology Research

Gilbert, Arizona, 85234, United States

Location

Pediatric Skin Research, LLC

Coral Gables, Florida, 33146, United States

Location

Skin Research of South Florida, LLC

Miami, Florida, 33173, United States

Location

Skin Care Physicians of Georgia

Macon, Georgia, 31217, United States

Location

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

Chicago, Illinois, 60611, United States

Location

DermAssociates, LLC

Rockville, Maryland, 20850, United States

Location

National Allergy and Asthma Research, LLC

North Charleston, South Carolina, 29420, United States

Location

Texas Dermatology and Laser Specialists

San Antonio, Texas, 78218, United States

Location

Virginia Clinical Research, Inc.

Norfolk, Virginia, 23502, United States

Location

Related Publications (1)

• 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.

  PMID: 39080094 DERIVED

MeSH Terms

Interventions

dupilumab

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2022
• First Posted: January 24, 2022
• Study Start: January 27, 2022
• Primary Completion: March 10, 2023
• Study Completion: March 10, 2023
• Last Updated: September 8, 2023

Record last verified: 2023-08

Locations

US (10)