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

Regeneron Pharmaceuticals

Status and phase

Completed

Phase 4

Conditions

Moderate-to-severe Atopic Dermatitis

Treatments

Drug: dupilumab

Study type

Observational

Funder types

Industry

Identifiers

R668-AD-2024

Details and patient eligibility

About

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).

Full description

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

Enrollment

45 patients

Sex

All

Ages

12 to 17 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

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

Key Exclusion Criteria:

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

NOTE: Other protocol defined inclusion/exclusion criteria apply