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NCT05042258 · ClinicalTrials.gov registry record · Phase 4
Using Dupilumab to Improve Circadian Function, Sleep and Pruritus in Children With Moderate/Severe Atopic Dermatitis
A Phase 4 study of Atopic Dermatitis and Sleep Disturbance, sponsored by Northwestern University.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT05042258: Recruiting Phase 4 study of Atopic Dermatitis and Sleep Disturbance, sponsored by Northwestern University.
NCT05042258 is a Phase 4 study of Atopic Dermatitis and Sleep Disturbance that is actively recruiting participants, run by Northwestern University. The registered enrollment target is 40 participants, below the 609-participant average among 150 other Atopic Dermatitis trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05042258, a Phase 4 study of Atopic Dermatitis and Sleep Disturbance, is actively recruiting participants, sponsored by Northwestern University.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study Summary
Single center, prospective, Open label study of sleep, pruritus and circadian function pre/post 12-weeks of dupilumab treatment in children 6-17 years old
Primary Outcome
Improvement from baseline in PROMIS Parent-Proxy sleep disturbance score (short format 8-item) after 12 weeks post dupilumab initiation. The minimum value is "Never" and the maximum value is "Always". Higher scores mean worse outcomes.
Conditions Studied
Interventions
- DRUG Dupilumab
Study Locations (1)
Illinois
- Lurie Children's Hospital/Northwestern University - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2024-08-12 |
| Est. Completion | 2025-12 |
| Phase | Phase 4 |
What NCT05042258 shows while recruiting
NCT05042258 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 609-participant average among 150 other Atopic Dermatitis trials with a reported enrollment target (93% lower).
The record links to 2 conditions, with Atopic Dermatitis appearing as the primary indexed condition, and to 1 intervention - of which Dupilumab is the first listed.
NCT05042258 reports a single indexed study location in Illinois.
Frequently Asked Questions
What is clinical trial NCT05042258 about?
NCT05042258 is a clinical study titled "Using Dupilumab to Improve Circadian Function, Sleep and Pruritus in Children With Moderate/Severe Atopic Dermatitis". Single center, prospective, Open label study of sleep, pruritus and circadian function pre/post 12-weeks of dupilumab treatment in children 6-17 years old
What is the current status of trial NCT05042258?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 40 participants. The study started on 2024-08-12. Estimated completion is 2025-12.
What conditions does trial NCT05042258 study?
This clinical trial studies the following conditions: Atopic Dermatitis, Sleep Disturbance.
What interventions are being tested in trial NCT05042258?
The interventions under investigation include: Dupilumab (DRUG).
Who is sponsoring clinical trial NCT05042258?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05042258 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Atopic Dermatitis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05042258's enrollment target sits among peer trials
40 114th of 150 higher than 36 of 150 other Atopic Dermatitis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Atopic Dermatitis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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