Neuropsychologic Assessments of Dupilumab-Treated Adolescent Participants With Moderate-to-Severe Atopic Dermatitis
NCT05203380, Completed, Regeneron Pharmaceuticals
Trial 9
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Neuropsychologic Assessments of Dupilumab-Treated Adolescent Participants With Moderate-to-Severe Atopic Dermatitis | ClinicalTrials.gov |
| NCT number | NCT05203380 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Enrollment | 45 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Regeneron Pharmaceuticals | ClinicalTrials.gov |
| Conditions | Moderate-to-severe Atopic Dermatitis | ClinicalTrials.gov |
| Interventions | dupilumab | ClinicalTrials.gov |
| First posted | 2022-01-24 | ClinicalTrials.gov |
| Last updated | 2023-09-08 | ClinicalTrials.gov |
Registered outcomes 43
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Proportion of AD patients with a Conner's CPT-3 d' T-score ≥ 60 | 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. | ClinicalTrials.gov |
| Primary | Mean change from baseline in Conner's CPT-3 d' T-score | At week 16 | Part B Conner's CPT-3 d' T-scoring as stated above. | ClinicalTrials.gov |
| Secondary | 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 | Part A Conner's CPT-3 d' T-scoring as stated above. EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. Four AD disease characteristics (erythema, thickness \[induration, apulation, edema\], scratching \[excoriation\], and lichenification) will each be assessed for severity by the investigator or designee on a scale of 0" (absent) through "3" (severe). In addition, the area of AD involvement will be assessed as a percentage by body area of head, trunk, upper limbs, and lower limbs, and converted to a score of 0 to 6. | ClinicalTrials.gov |
| Secondary | Correlation of values for Conners' CPT-3 scores with AD disease severity based on Body Surface Area (BSA) | Day 1 | Part A Conner's CPT-3 d' T-scoring as stated above. BSA affected by AD is assessed for each section of the body using the rule of nines (the possible highest score for each region is: head and neck \[9%\], anterior trunk \[18%\], back \[18%\], upper limbs \[18%\], lower limbs \[36%\], and genitals \[1%\]) and will be reported as a percentage of all major body sections combined. | ClinicalTrials.gov |
| Secondary | Correlation of values for Conners' CPT-3 scores with AD disease severity based on Peak Pruritus Numeric Rating Scale (NRS) | Day 1 | Part A Conner's CPT-3 d' T-scoring as stated above. Peak Pruritus NRS is a simple assessment tool that patients will use to report the average intensity of their pruritus (itch), both maximum and average intensity, during a 24-hour recall period; maximum itch intensity on a scale of 0 - 10 (0 = no itch; 10 = worst itch imaginable). | ClinicalTrials.gov |
| Secondary | Correlation of values for Conners' CPT-3 scores with AD disease severity based on Skin Pain Numeric Rating Scale (SP-NRS) | Day 1 | Part A Conner's CPT-3 d' T-scoring as stated above. SP-NRS is a validated, self-administered PRO measuring the skin pain severity at its worst with a recall period of 24 hours pain severity in adults and adolescents. This single-item questionnaire uses an 11-point scale, which ranges from "0-No pain" to "10-Worst pain possible." Skin pain severity based on SP-NRS can be categorized as: clear (0), mild (1-3), moderate (5-6), severe (7-9), and very severe (10). | ClinicalTrials.gov |
| Secondary | 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 | Part A Conner's CPT-3 d' T-scoring as stated above. PROMIS sleep disturbance questionnaire is used to measure self-reported perceptions of sleep quality, sleep depth, and restoration. This includes perceived difficulties getting to sleep and staying asleep, as well as sleep satisfaction. Parent-reported sleep. | ClinicalTrials.gov |
| Secondary | Correlation of values for Conners' CPT-3 scores with AD disease severity based on Children's Dermatology Life Quality Index (CDLQI) | Day 1 | Part A Conner's CPT-3 d' T-scoring as stated above. CDLQI is a validated questionnaire designed to measure the impact of skin disease on the quality of life (QoL) in children over a recall period of the past week. 9 of the 10 questions are scored by (0) Not answered/not at all, (1) only a little, (2) quite a lot to (3) very much. Question 7 has a possible response of (3) prevented school. The sum of the score of each question has a maximum of 30 and a minimum of 0. The higher the score the greater the impact on QoL. CDLQI can be a percentage of the maximum possible score of 30. | ClinicalTrials.gov |
| Secondary | Correlation of values for Conners' CPT-3 scores with AD disease severity based on Hospital Anxiety and Depression Scale (HADS) | Day 1 | Part A Conner's CPT-3 d' T-scoring as stated above. HADS is an instrument for screening anxiety and depression in non-psychiatric populations; repeated administration also provides information about changes in a patient's emotional state. HADS consists of 14 items, 7 each for anxiety and depression symptoms; possible scores range from 0 to 21 for each subscale. The following cut-off scores are recommended for both subscales: 7 to 8 for possible presence, 10 to 11 for probable presence, and 14 to 15 for severe anxiety or depression. | ClinicalTrials.gov |
| Secondary | Correlation of values for Conners' CPT-3 scores with AD disease severity based on Investigator's Global Assessment (IGA) | Day 1 | Part A Conner's CPT-3 d' T-scoring as stated above. IGA is an instrument used for rapid and easy assessment of atopic dermatitis disease lesional severity globally based on a 5-point scale with range from 0-4, (0 = Clear, 1 = Almost clear, 2 = Mild disease, 3 = Moderate disease and 4 = Severe disease). | ClinicalTrials.gov |
| Secondary | Correlation of values for Adult/Adolescent Sensory Profile (AASP) Sensory Sensitivity Score with AD disease severity based on EASI | Day 1 | Part A AASP is a 60-item self-report questionnaire measuring sensory responsiveness patterns in six different sensory modalities, including taste/smell, movement, visual, touch, activity and auditory processing. Patients complete the AASP by responding to each item with a five-point Likert scale (1 = almost never, 2 = seldom, 3 =occasionally, 4 = frequently, or 5 = always). Higher scores in each quadrant represented stronger preference to adopt certain types of sensory responsiveness patterns. The quadrant score can be categorized into one of the 5 categories, indicating how a particular patient's score compares to people in the same age group (adolescents of age 11-17 years) without disabilities: much less than most people, less than most people, similar to most people, more than most people, much more than most people. EASI measuring as stated above. | ClinicalTrials.gov |
| Secondary | Correlation of values for AASP Sensory Sensitivity Score with AD disease severity based on BSA | Day 1 | Part A AASP scoring as stated above. BSA scoring as stated above. | ClinicalTrials.gov |
| Secondary | Correlation of values for AASP Sensory Sensitivity Score with AD disease severity based on Peak Pruritus NRS | Day 1 | Part A AASP scoring as stated above. Peak Pruritus NRS scaling as stated above. | ClinicalTrials.gov |
| Secondary | Correlation of values for AASP Sensory Sensitivity Score with AD disease severity based on SP-NRS | Day 1 | Part A AASP scoring as stated above. SP-NRS scaling as stated above. | ClinicalTrials.gov |
| Secondary | Correlation of values for AASP Sensory Sensitivity Score with AD disease severity based on PROMIS Pediatric Sleep Disturbance Questionnaire | Day 1 | Part A AASP scoring as stated above. PROMIS Pediatric sleep disturbance scaling as stated above. | ClinicalTrials.gov |
| Secondary | Correlation of values for AASP Sensory Sensitivity Score with AD disease severity based on CDLQI | Day 1 | Part A AASP scoring as stated above. CDLQI scoring as stated above. | ClinicalTrials.gov |
| Secondary | Correlation of values for AASP Sensory Sensitivity Score with AD disease severity based on HADS | Day 1 | Part A AASP scoring as stated above. HADS scoring as stated above. | ClinicalTrials.gov |
| Secondary | Correlation of values for AASP Sensory Sensitivity Score with AD disease severity based on IGA | Day 1 | Part A AASP scoring as stated above. IGA scoring as stated above. | ClinicalTrials.gov |
| Secondary | Correlation of values for Stroop Interference Score with AD disease severity based on EASI | Day 1 | Part A Stroop Color and Word Test (SCWT) is a test used to measure selective inhibition, the ability to attend to certain environmental stimuli while inhibiting other stimuli. Stroop Interference scores are calculated from the number of correctly identified items in the three trials. Higher Stroop Interference scores represent poorer performance and suggests impaired executive functioning. EASI scoring as stated above. | ClinicalTrials.gov |
| Secondary | Correlation of values for SCWT Interference Score with AD disease severity based on BSA | Day 1 | Part A SCWT scoring as stated above. BSA scoring as stated above. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|---|---|
| 39080094 | DERIVED | PubMed |
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 2
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Continuous Performance Test | Primary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)