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

  • STATUS
    Recruiting
  • End date
    Aug 12, 2024
  • participants needed
    82
  • sponsor
    Regeneron Pharmaceuticals
Updated on 20 October 2022

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).

Details
Condition Moderate-to-severe Atopic Dermatitis
Treatment Dupilumab
Clinical Study IdentifierNCT05203380
SponsorRegeneron Pharmaceuticals
Last Modified on20 October 2022

Eligibility

Yes No Not Sure

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

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
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
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