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NCT05203380 · ClinicalTrials.gov registry record
Neuropsychologic Assessments of Dupilumab-Treated Adolescent Participants With Moderate-to-Severe Atopic Dermatitis
A clinical trial, sponsored by Regeneron Pharmaceuticals.
- Completed
- Registry status
- 45
- Enrollment target
NCT05203380: Completed study, sponsored by Regeneron Pharmaceuticals.
NCT05203380 is a clinical trial that has completed, run by Regeneron Pharmaceuticals. The registered enrollment target is 45 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05203380 has completed, sponsored by Regeneron Pharmaceuticals.
- COMPLETED
- Registry status
- 45 participants
- Enrollment target
Study 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).
Primary Outcome
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
Interventions
- DRUG dupilumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2022-01-27 |
| Est. Completion | 2023-03-10 |
What the finished NCT05203380 record still lists
NCT05203380 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 45 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which dupilumab is the first listed.
NCT05203380 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05203380 about?
NCT05203380 is a clinical study titled "Neuropsychologic Assessments of Dupilumab-Treated Adolescent Participants With Moderate-to-Severe Atopic Dermatitis". 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 ...
What is the current status of trial NCT05203380?
This trial is currently completed. The enrollment target is 45 participants. The study started on 2022-01-27. Estimated completion is 2023-03-10.
What interventions are being tested in trial NCT05203380?
The interventions under investigation include: dupilumab (DRUG).
Who is sponsoring clinical trial NCT05203380?
This trial is sponsored by Regeneron Pharmaceuticals, which has 280 total clinical trials registered on ClinicalTrials.gov.
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