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NCT05983068 · ClinicalTrials.gov registry record · Phase 4
A Study of Long-term Effect of Dupilumab on Skin Barrier Function in Pediatric Participants With Atopic Dermatitis
A Phase 4 study of Dermatitis, Atopic, sponsored by Sanofi.
- Active
- Registry status
- Phase 4
- Development phase
- 48
- Enrollment target
- 4
- Study locations
NCT05983068: Active Phase 4 study of Dermatitis, Atopic, sponsored by Sanofi.
NCT05983068 is a Phase 4 study of Dermatitis, Atopic that is active but no longer recruiting, run by Sanofi. The registered enrollment target is 48 participants, below the 395-participant average among 29 other Dermatitis, Atopic trials with a reported enrollment target (88% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05983068, a Phase 4 study of Dermatitis, Atopic, is active but no longer recruiting, sponsored by Sanofi.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 4
- Development phase
- 48 participants
- Enrollment target
- 4
- Study locations
Study Summary
This is a 2-year, open-label, exploratory study with a 4-week screening period and a 104-week treatment phase designed to investigate dupilumab's long-term effect on skin barrier function as measured by transepidermal water loss (TEWL) before and after skin tape stripping (STS) in approximately 48 pediatric participants (aged ≥6 and \<15 years at study entry) with moderate-to-severe AD. All eligible participants with AD will be treated with Dupixent® for 104 weeks according to locally approved Dupixent® product label (in country/region where the study is conducted). After the 104-week treatment phase and the last assessment at the End of Treatment (EoT), participants will be followed-up for 4 weeks and an End-of-Study (EoS) visit by telephone at 4 weeks after the EoT visit will end the study for each participant. The maximum duration of the study per participant will be 112 weeks (including screening period). The study population will include approximately 48 pediatric participants with AD for long-term treatment with dupilumab: * Treatment cohort 1 - newly recruited participants with AD (aged ≥6 to \<12 years at study entry) * Treatment cohort 2 - any former PELISTAD participants (from the previous 16-week treatment study \[PELISTAD/LPS16764\] who consent to participate in this long-term study; aged ≥6 to \<15 years at entry to this study)
Primary Outcome
Percent change from baseline in TEWL after 5 STS assessed on lesional skin.
Conditions Studied
Interventions
- DRUG dupilumab
Study Locations (4)
Colorado
- National Jewish Health Medical Center- Site Number : 8400001 - Denver
Missouri
- SSM Health Saint Louis University Hospital- Site Number : 8400006 - St Louis
New York
- NYU Langone Medical Center- Site Number : 8400004 - New York
Other
- Investigational Site Number : 8260001 - Sheffield
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2024-02-22 |
| Est. Completion | 2026-08-07 |
| Phase | Phase 4 |
What the registry record for NCT05983068 still lists
NCT05983068 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 395-participant average among 29 other Dermatitis, Atopic trials with a reported enrollment target (88% lower).
The record links to 1 condition, with Dermatitis, Atopic appearing as the primary indexed condition, and to 1 intervention - of which dupilumab is the first listed.
NCT05983068 reports a single indexed study location in Colorado, Missouri, New York.
Frequently Asked Questions
What is clinical trial NCT05983068 about?
NCT05983068 is a clinical study titled "A Study of Long-term Effect of Dupilumab on Skin Barrier Function in Pediatric Participants With Atopic Dermatitis". This is a 2-year, open-label, exploratory study with a 4-week screening period and a 104-week treatment phase designed to investigate dupilumab's long-term effect on skin barrier function as measured by transepidermal water loss (TEWL) before and after skin tape stripping (STS) in approximately 48 p...
What is the current status of trial NCT05983068?
This trial is currently active not recruiting. It is a Phase 4 study. The enrollment target is 48 participants. The study started on 2024-02-22. Estimated completion is 2026-08-07.
What conditions does trial NCT05983068 study?
This clinical trial studies the following conditions: Dermatitis, Atopic.
What interventions are being tested in trial NCT05983068?
The interventions under investigation include: dupilumab (DRUG).
Who is sponsoring clinical trial NCT05983068?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05983068 being conducted?
This trial has 4 study locations across Colorado, Missouri, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Dermatitis, Atopic
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 NCT05983068's enrollment target sits among peer trials
48 26th of 29 higher than 4 of 29 other Dermatitis, Atopic trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Dermatitis, Atopic 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.
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