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NCT04033367 · ClinicalTrials.gov registry record · Phase 4
SAR231893-LPS15497- "Dupilumab Effect on Sleep in AD Patients"
A Phase 4 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 4
- Development phase
- 188
- Enrollment target
NCT04033367: Completed Phase 4 study, sponsored by Sanofi.
NCT04033367 is a Phase 4 study that has completed, run by Sanofi. The registered enrollment target is 188 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (64% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04033367, a Phase 4 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 188 participants
- Enrollment target
Study Summary
Primary Objective: To evaluate the effect of dupilumab on sleep quality in adult participants with moderate to severe atopic dermatitis (AD). Secondary Objectives: To evaluate the effect of dupilumab on objective and subjective quantitative sleep parameters, AD related outcomes, and daytime consequences of sleep deprivation. To continue to assess the safety and tolerability throughout the study.
Primary Outcome
Sleep quality NRS was used to assess the quality of the participant's previous night's sleep. It was collected on a 11-point scale ranged from 0 (worst possible sleep) to 10 (best possible sleep), where higher score indicated better outcome. Percent change from Baseline in sleep quality NRS at Week 12 was reported in this outcome measure.
Interventions
- DRUG Placebo
- DRUG Dupilumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 188 participants |
| Start Date | 2019-08-22 |
| Est. Completion | 2021-10-06 |
| Phase | Phase 4 |
What the finished NCT04033367 record still lists
NCT04033367 is an interventional study that assigns participants to a tested intervention. The registered 188 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (64% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04033367 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04033367 about?
NCT04033367 is a clinical study titled "SAR231893-LPS15497- "Dupilumab Effect on Sleep in AD Patients"". Primary Objective: To evaluate the effect of dupilumab on sleep quality in adult participants with moderate to severe atopic dermatitis (AD). Secondary Objectives: To evaluate the effect of dupilumab on objective and subjective quantitative sleep parameters, AD related outcomes, and daytime conse...
What is the current status of trial NCT04033367?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 188 participants. The study started on 2019-08-22. Estimated completion is 2021-10-06.
What interventions are being tested in trial NCT04033367?
The interventions under investigation include: Placebo (DRUG), Dupilumab (DRUG).
Who is sponsoring clinical trial NCT04033367?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04033367's enrollment target sits among peer trials
188 456th of 2000 higher than 1,542 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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