NCT05203380已完成不适用
Neuropsychologic Assessments of Dupilumab-Treated Adolescents With Moderate-to-Severe Atopic Dermatitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 10
- 主要终点
- Proportion of AD patients with a Conner's CPT-3 d' T-score ≥ 60
研究概览
简要总结
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).
详细描述
Per protocol Study Stop Criteria, study has concluded with Part A. Part B was not initiated and no data were collected.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Part B
Patients in Part A may also enroll in Part B provided they meet the eligibility criteria.
干预措施: dupilumab (Drug)
结局指标
主要结局
Proportion of AD patients with a Conner's CPT-3 d' T-score ≥ 60
时间窗: Day 1
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.
Mean change from baseline in Conner's CPT-3 d' T-score
时间窗: At week 16
Part B Conner's CPT-3 d' T-scoring as stated above.
次要结局
- 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)
- Correlation of values for SCWT Interference Score with AD disease severity based on BSA(Day 1)
- Correlation of values for Stroop Interference Score with AD disease severity based on Peak Pruritus NRS(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 Children's Dermatology Life Quality Index (CDLQI)(Day 1)
- Correlation of values for Conners' CPT-3 scores with AD disease severity based on Hospital Anxiety and Depression Scale (HADS)(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 AASP Sensory Sensitivity Score with AD disease severity based on PROMIS Pediatric Sleep Disturbance Questionnaire(Day 1)
- Correlation of values for Stroop Interference Score with AD disease severity based on EASI(Day 1)
- Correlation of values for Stroop Interference Score with AD disease severity based on CDLQI(Day 1)
- Correlation of change in AD disease severity based on BSA with change in Conners' CPT-3 score(Up to Week 16)
- Correlation of change in AD disease severity based on SP-NRS with change in Conners' CPT-3 score(Up to Week 16)
- 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 AASP Sensory Sensitivity Score with AD disease severity based on SP-NRS(Day 1)
- Correlation of values for AASP Sensory Sensitivity Score with AD disease severity based on CDLQI(Day 1)
- Correlation of values for Stroop Interference Score with AD disease severity based on SP-NRS(Day 1)
- Correlation of change in AD disease severity based on CDLQI with change in Conners' CPT-3 score(Up to Week 16)
- Correlation of values for AASP Sensory Sensitivity Score with AD disease severity based on IGA(Day 1)
- Correlation of change in AD disease severity based on CDLQI with AASP Sensory Sensitivity Summary Score(Up to Week 16)
- 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 Investigator's Global Assessment (IGA)(Day 1)
- Correlation of values for AASP Sensory Sensitivity Score with AD disease severity based on HADS(Day 1)
- Correlation of values for Stroop Interference Score with AD disease severity based on PROMIS Pediatric Sleep Disturbance Questionnaire(Day 1)
- Determine the appropriate minimal Conners' CPT-3 d-prime T score(Day 1)
- Correlation of change in AD disease severity based on HADS with change in Conners' CPT-3 score(Up to Week 16)
- Correlation of change in AD disease severity based on IGA with change in Conners' CPT-3 score(Up to Week 16)
- Correlation of change in AD disease severity based on BSA with AASP Sensory Sensitivity Summary Score(Up to Week 16)
- Correlation of change in AD disease severity based on HADS with AASP Sensory Sensitivity Summary Score(Up to Week 16)
- Correlation of change in AD disease severity based on IGA with AASP Sensory Sensitivity Summary Score(Up to Week 16)
- Correlation of values for Adult/Adolescent Sensory Profile (AASP) Sensory Sensitivity Score with AD disease severity based on EASI(Day 1)
- Correlation of values for AASP Sensory Sensitivity Score with AD disease severity based on BSA(Day 1)
- Correlation of values for AASP Sensory Sensitivity Score with AD disease severity based on Peak Pruritus NRS(Day 1)
- Correlation of change in AD disease severity based on EASI with change in Conners' CPT-3 score(Up to Week 16)
- Correlation of change in AD disease severity based on Peak Pruritus NRS with change in Conners' CPT-3 score(Up to Week 16)
- Correlation of change in AD disease severity based on PROMIS Pediatric Sleep Disturbance with AASP Sensory Sensitivity Summary Score(Up to Week 16)
- Correlation of values for Stroop Interference Score with AD disease severity based on HADS(Day 1)
- Correlation of values for Stroop Interference Score with AD disease severity based on IGA(Day 1)
- Correlation of change in AD disease severity based on PROMIS Pediatric Sleep Disturbance with change in Conners' CPT-3 score(Up to Week 16)
- Correlation of change in AD disease severity based on EASI with AASP Sensory Sensitivity Summary Score(Up to Week 16)
- Correlation of change in AD disease severity based on Peak Pruritus NRS with AASP Sensory Sensitivity Summary Score(Up to Week 16)
- Correlation of change in AD disease severity based on SP-NRS with AASP Sensory Sensitivity Summary Score(Up to Week 16)
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