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NCT04162769 · ClinicalTrials.gov registry record · Phase 2
A Study to Assess the Safety and Efficacy of Etrasimod in Subjects With Moderate-to-Severe Atopic Dermatitis
A Phase 2 study of Atopic Dermatitis, sponsored by Arena Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 140
- Enrollment target
- 20
- Study locations
NCT04162769: Completed Phase 2 study of Atopic Dermatitis, sponsored by Arena Pharmaceuticals.
NCT04162769 is a Phase 2 study of Atopic Dermatitis that has completed, run by Arena Pharmaceuticals. The registered enrollment target is 140 participants, below the 609-participant average among 150 other Atopic Dermatitis trials with a reported enrollment target (77% lower). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04162769, a Phase 2 study of Atopic Dermatitis, has completed, sponsored by Arena Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 140 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to determine whether etrasimod is a safe and effective treatment for moderate-to-severe atopic dermatitis (AD).
Primary Outcome
EASI evaluates severity of participant's AD based on severity of AD clinical signs and percent (%) of body surface area (BSA) affected. EASI is a composite scoring assessment of the affected area in 4 specific disease characteristics (erythema, thickness \[induration, papulation, edema\], scratching \[excoriation\], and lichenification), which was each assessed on a scale of "0" (absent) through "3" (severe). The EASI Area Score is documented for 4 regions of the body. Region 1: head and neck; R
Conditions Studied
Interventions
- DRUG Etrasimod 1 mg
- DRUG Etrasimod 2 mg
- DRUG Etrasimod matching placebo
Study Locations (20)
Florida
- Clinical Research of West Florida - Clearwater
- Prohealth Research Center - Doral
- Aby's New Generation Research, Inc. - Hialeah
- Skin Care Research, LLC - Hollywood
- Advanced Research Institute of Miami LLC - Homestead
- Amber Pediatrics Research, LLC - Homestead
- South Miami Medical & Research Group. Inc - Miami
- Amber Pediatrics Research, LLC - Miami
- Skin Research of South Florida - Miami
- Amber Clinical Research, LLC - Miami Shores
- IMA Clinical Research, LLC - St. Petersburg
- Clinical Research of West Florida, Inc. - Tampa
California
- Hope Clinical Research - Canoga Park
- First OC Dermatology - Fountain Valley
- Marvel Research LLC - Huntington Beach
- ADVA Clinical Research, Inc - Inglewood
- Providence Clinical Research - North Hollywood
- TCR Medical Corporation - San Diego
Arizona
- Noble Clinical Research - Tucson
Georgia
- Rophe Adult and Pediatric Medicine/SKYCRNG - Union City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 140 participants |
| Start Date | 2019-10-04 |
| Est. Completion | 2021-10-11 |
| Phase | Phase 2 |
What the finished NCT04162769 record still lists
NCT04162769 is an interventional study that assigns participants to a tested intervention. The registered 140 participants enrollment target is mid-sized for trials with a published cap, below the 609-participant average among 150 other Atopic Dermatitis trials with a reported enrollment target (77% lower).
The record links to 1 condition, with Atopic Dermatitis appearing as the primary indexed condition, and to 3 interventions - of which Etrasimod 1 mg is the first listed.
NCT04162769 names 20 study sites across 4 states, led by Florida, California, Arizona.
Frequently Asked Questions
What is clinical trial NCT04162769 about?
NCT04162769 is a clinical study titled "A Study to Assess the Safety and Efficacy of Etrasimod in Subjects With Moderate-to-Severe Atopic Dermatitis". The purpose of this study is to determine whether etrasimod is a safe and effective treatment for moderate-to-severe atopic dermatitis (AD).
What is the current status of trial NCT04162769?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 140 participants. The study started on 2019-10-04. Estimated completion is 2021-10-11.
What conditions does trial NCT04162769 study?
This clinical trial studies the following conditions: Atopic Dermatitis.
What interventions are being tested in trial NCT04162769?
The interventions under investigation include: Etrasimod 1 mg (DRUG), Etrasimod 2 mg (DRUG), Etrasimod matching placebo (DRUG).
Who is sponsoring clinical trial NCT04162769?
This trial is sponsored by Arena Pharmaceuticals, which has 15 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04162769 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04162769's enrollment target sits among peer trials
140 75th of 150 higher than 76 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.
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