Clinical trial NCT05203380: Neuropsychologic Assessments of Dupilumab-Treated Adolescent Participants With Moderate-to-Severe Atopic Dermatitis
Official title: Neuropsychologic Assessments of Dupilumab-Treated Adolescents With Moderate-to-Severe Atopic Dermatitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Moderate-to-severe Atopic Dermatitis
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Sanofi
First posted: 2022-01-24
Enrollment: 45
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: Key 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

Key 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

NOTE: Other protocol defined inclusion/exclusion criteria apply

Primary outcomes:
measure: Proportion of AD patients with a Conner's CPT-3 d' T-score ≥ 60
timeFrame: Day 1
measure: Mean change from baseline in Conner's CPT-3 d' T-score
timeFrame: At week 16
Secondary outcomes:
measure: 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)
timeFrame: Day 1
measure: Correlation of values for Conners' CPT-3 scores with AD disease severity based on Body Surface Area (BSA)
timeFrame: Day 1
measure: Correlation of values for Conners' CPT-3 scores with AD disease severity based on Peak Pruritus Numeric Rating Scale (NRS)
timeFrame: Day 1
measure: Correlation of values for Conners' CPT-3 scores with AD disease severity based on Skin Pain Numeric Rating Scale (SP-NRS)
timeFrame: Day 1
measure: 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)
timeFrame: Day 1
measure: Correlation of values for Conners' CPT-3 scores with AD disease severity based on Children's Dermatology Life Quality Index (CDLQI)
timeFrame: Day 1
measure: Correlation of values for Conners' CPT-3 scores with AD disease severity based on Hospital Anxiety and Depression Scale (HADS)
timeFrame: Day 1
measure: Correlation of values for Conners' CPT-3 scores with AD disease severity based on Investigator's Global Assessment (IGA)
timeFrame: Day 1
measure: Correlation of values for Adult/Adolescent Sensory Profile (AASP) Sensory Sensitivity Score with AD disease severity based on EASI
timeFrame: Day 1
measure: Correlation of values for AASP Sensory Sensitivity Score with AD disease severity based on BSA
timeFrame: Day 1
measure: Correlation of values for AASP Sensory Sensitivity Score with AD disease severity based on Peak Pruritus NRS
timeFrame: Day 1
measure: Correlation of values for AASP Sensory Sensitivity Score with AD disease severity based on SP-NRS
timeFrame: Day 1
measure: Correlation of values for AASP Sensory Sensitivity Score with AD disease severity based on PROMIS Pediatric Sleep Disturbance Questionnaire
timeFrame: Day 1
measure: Correlation of values for AASP Sensory Sensitivity Score with AD disease severity based on CDLQI
timeFrame: Day 1
measure: Correlation of values for AASP Sensory Sensitivity Score with AD disease severity based on HADS
timeFrame: Day 1
measure: Correlation of values for AASP Sensory Sensitivity Score with AD disease severity based on IGA
timeFrame: Day 1
measure: Correlation of values for Stroop Interference Score with AD disease severity based on EASI
timeFrame: Day 1
measure: Correlation of values for SCWT Interference Score with AD disease severity based on BSA
timeFrame: Day 1
measure: Correlation of values for Stroop Interference Score with AD disease severity based on Peak Pruritus NRS
timeFrame: Day 1
measure: Correlation of values for Stroop Interference Score with AD disease severity based on SP-NRS
timeFrame: Day 1
measure: Correlation of values for Stroop Interference Score with AD disease severity based on PROMIS Pediatric Sleep Disturbance Questionnaire
timeFrame: Day 1
measure: Correlation of values for Stroop Interference Score with AD disease severity based on CDLQI
timeFrame: Day 1
measure: Correlation of values for Stroop Interference Score with AD disease severity based on HADS
timeFrame: Day 1
measure: Correlation of values for Stroop Interference Score with AD disease severity based on IGA
timeFrame: Day 1
measure: Determine the appropriate minimal Conners' CPT-3 d-prime T score
timeFrame: Day 1
measure: Correlation of change in AD disease severity based on EASI with change in Conners' CPT-3 score
timeFrame: Up to Week 16
measure: Correlation of change in AD disease severity based on BSA with change in Conners' CPT-3 score
timeFrame: Up to Week 16
measure: Correlation of change in AD disease severity based on Peak Pruritus NRS with change in Conners' CPT-3 score
timeFrame: Up to Week 16
measure: Correlation of change in AD disease severity based on SP-NRS with change in Conners' CPT-3 score
timeFrame: Up to Week 16
measure: Correlation of change in AD disease severity based on PROMIS Pediatric Sleep Disturbance with change in Conners' CPT-3 score
timeFrame: Up to Week 16
measure: Correlation of change in AD disease severity based on CDLQI with change in Conners' CPT-3 score
timeFrame: Up to Week 16
measure: Correlation of change in AD disease severity based on HADS with change in Conners' CPT-3 score
timeFrame: Up to Week 16
measure: Correlation of change in AD disease severity based on IGA with change in Conners' CPT-3 score
timeFrame: Up to Week 16
measure: Correlation of change in AD disease severity based on EASI with AASP Sensory Sensitivity Summary Score
timeFrame: Up to Week 16
measure: Correlation of change in AD disease severity based on BSA with AASP Sensory Sensitivity Summary Score
timeFrame: Up to Week 16
measure: Correlation of change in AD disease severity based on Peak Pruritus NRS with AASP Sensory Sensitivity Summary Score
timeFrame: Up to Week 16
measure: Correlation of change in AD disease severity based on SP-NRS with AASP Sensory Sensitivity Summary Score
timeFrame: Up to Week 16
measure: Correlation of change in AD disease severity based on PROMIS Pediatric Sleep Disturbance with AASP Sensory Sensitivity Summary Score
timeFrame: Up to Week 16
measure: Correlation of change in AD disease severity based on CDLQI with AASP Sensory Sensitivity Summary Score
timeFrame: Up to Week 16
measure: Correlation of change in AD disease severity based on HADS with AASP Sensory Sensitivity Summary Score
timeFrame: Up to Week 16
measure: Correlation of change in AD disease severity based on IGA with AASP Sensory Sensitivity Summary Score
timeFrame: Up to Week 16
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Clinical Research Center of Alabama, LLC
state: Alabama
city: Gilbert
country: United States
facility: Arizona Allergy & Immunology Research
state: Arizona
city: Coral Gables
country: United States
facility: Pediatric Skin Research, LLC
state: Florida
city: Miami
country: United States
facility: Skin Research of South Florida, LLC
state: Florida
city: Macon
country: United States
facility: Skin Care Physicians of Georgia
state: Georgia
city: Chicago
country: United States
facility: Ann & Robert H. Lurie Children's Hospital of Chicago
state: Illinois
city: Rockville
country: United States
facility: DermAssociates, LLC
state: Maryland
city: North Charleston
country: United States
facility: National Allergy and Asthma Research, LLC
state: South Carolina
city: San Antonio
country: United States
facility: Texas Dermatology and Laser Specialists
state: Texas
city: Norfolk
country: United States
facility: Virginia Clinical Research, Inc.
state: Virginia
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Clinical Trial Management
role: STUDY_DIRECTOR
References: