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NCT04823130 · ClinicalTrials.gov registry record · Phase 4
Dupilumab Effect on Pruritus Neuro-mechanisms in Patients With Atopic Dermatitis
A Phase 4 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 4
- Development phase
- 54
- Enrollment target
NCT04823130: Completed Phase 4 study, sponsored by Sanofi.
NCT04823130 is a Phase 4 study that has completed, run by Sanofi. The registered enrollment target is 54 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04823130, a Phase 4 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 54 participants
- Enrollment target
Study Summary
Primary Objective: \- Assess change in neuronal architecture following long term treatment with dupilumab in skin biopsies from atopic dermatitis (AD) participants with chronic pruritus. Secondary Objectives: * Assess change in neuronal architecture following short term treatment with dupilumab and during follow-up in skin biopsies from AD participants with chronic pruritus. * To evaluate the efficacy of dupilumab in AD participants with chronic pruritus. * To evaluate the safety of dupilumab in adult participants with moderate-to-severe AD.
Primary Outcome
Skin biopsies were used to analyze the epidermal nerve fiber density. Nerve fibers were visualized by staining consecutive sections for the pan-axonal marker protein gene product 9.5 (PGP9.5); and the basement membrane was visualized by staining for collagen type 4. Quantification of intraepidermal nerve fiber density was calculated by assessing nerve fibers crossing the basement membrane per square millimeter (F/mm\^2). Data for this outcome measure was not planned to be collected and analyzed
Interventions
- DRUG Dupilumab (SAR231893)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2021-04-22 |
| Est. Completion | 2022-08-30 |
| Phase | Phase 4 |
What the finished NCT04823130 record still lists
NCT04823130 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 54 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 1 intervention - of which Dupilumab (SAR231893) is the first listed.
NCT04823130 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04823130 about?
NCT04823130 is a clinical study titled "Dupilumab Effect on Pruritus Neuro-mechanisms in Patients With Atopic Dermatitis". Primary Objective: \- Assess change in neuronal architecture following long term treatment with dupilumab in skin biopsies from atopic dermatitis (AD) participants with chronic pruritus. Secondary Objectives: * Assess change in neuronal architecture following short term treatment with dupilumab a...
What is the current status of trial NCT04823130?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 54 participants. The study started on 2021-04-22. Estimated completion is 2022-08-30.
What interventions are being tested in trial NCT04823130?
The interventions under investigation include: Dupilumab (SAR231893) (DRUG).
Who is sponsoring clinical trial NCT04823130?
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 NCT04823130's enrollment target sits among peer trials
54 1223rd of 2000 higher than 772 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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