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NCT05590585 · ClinicalTrials.gov registry record · Phase 4
Dupilumab in Adolescent and Adult Skin of Color Participants: Open-label Moderate-to-severe Eczema Trial
A Phase 4 study, sponsored by Regeneron Pharmaceuticals.
- Completed
- Registry status
- Phase 4
- Development phase
- 124
- Enrollment target
NCT05590585: Completed Phase 4 study, sponsored by Regeneron Pharmaceuticals.
NCT05590585 is a Phase 4 study that has completed, run by Regeneron Pharmaceuticals. The registered enrollment target is 124 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (76% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05590585, a Phase 4 study, has completed, sponsored by Regeneron Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 124 participants
- Enrollment target
Study Summary
The study is focused on skin of color participants who have moderate-to-severe atopic dermatitis. Atopic dermatitis, also referred to as eczema, is a condition that causes the skin to become itchy, dry, and cracked. From the previous studies on the study drug, it is seen that the study drug has an acceptable safety and effectiveness in participants with atopic dermatitis. The aim of this study is to get additional information on the safety and effectiveness of the study drug, particularly the information on aspects of atopic dermatitis in skin of color participants. The study is looking at several other research questions, including: * What side effects may happen from taking the study drug * How much study drug is in your blood at different times * How much the study drug improves quality of life and mental health
Primary Outcome
The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. EASI-75 responders were the participants who achieved ≥75% overall improvement in EASI score from baseline to Week 24.
Interventions
- DRUG dupilumab
- OTHER Topical emollient (moisturizer)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 124 participants |
| Start Date | 2023-01-11 |
| Est. Completion | 2024-11-14 |
| Phase | Phase 4 |
What the finished NCT05590585 record still lists
NCT05590585 is an interventional study that assigns participants to a tested intervention. The registered 124 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 (76% lower).
The record links to 0 conditions, and to 2 interventions - of which dupilumab is the first listed.
NCT05590585 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05590585 about?
NCT05590585 is a clinical study titled "Dupilumab in Adolescent and Adult Skin of Color Participants: Open-label Moderate-to-severe Eczema Trial". The study is focused on skin of color participants who have moderate-to-severe atopic dermatitis. Atopic dermatitis, also referred to as eczema, is a condition that causes the skin to become itchy, dry, and cracked. From the previous studies on the study drug, it is seen that the study drug has an ...
What is the current status of trial NCT05590585?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 124 participants. The study started on 2023-01-11. Estimated completion is 2024-11-14.
What interventions are being tested in trial NCT05590585?
The interventions under investigation include: dupilumab (DRUG), Topical emollient (moisturizer) (OTHER).
Who is sponsoring clinical trial NCT05590585?
This trial is sponsored by Regeneron Pharmaceuticals, which has 280 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05590585's enrollment target sits among peer trials
124 656th of 2000 higher than 1,339 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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