A Study to Assess the Safety and Efficacy of Etrasimod in Subjects With Moderate-to-Severe Atopic Dermatitis
ADVISE
A Multicenter, Randomized, Double-Blinded, Placebo-Controlled 16-Week Study (With a 52-Week Open-Label Extension) to Assess the Safety and Efficacy of Etrasimod in Subjects With Moderate-to-Severe Atopic Dermatitis
1 other identifier
interventional
140
3 countries
38
Brief Summary
The purpose of this study is to determine whether etrasimod is a safe and effective treatment for moderate-to-severe atopic dermatitis (AD).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2019
38 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 4, 2019
CompletedFirst Submitted
Initial submission to the registry
November 12, 2019
CompletedFirst Posted
Study publicly available on registry
November 14, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 9, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 11, 2021
CompletedResults Posted
Study results publicly available
November 4, 2022
CompletedNovember 4, 2022
October 1, 2022
11 months
November 12, 2019
August 24, 2022
October 10, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Double-blind Treatment Period: Percent Change in Eczema Area and Severity Index (EASI) Score
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; Region 2: trunk (including genital area); Region 3: upper limbs; and Region 4: lower limbs (including buttocks), with the area of AD involvement assessed as a percentage by body area and converted to a score of 0 to 6. Total EASI score ranged from 0 to 72; higher score indicated greater severity of AD. Baseline is defined as Day 1 pre-randomization assessments.
Baseline (Day 1) and Week 12
Secondary Outcomes (16)
Double-blind Treatment Period: Percentage of Participants Achieving EASI-75
Baseline (Day 1) and Week 12
Double-blind Treatment Period: Percentage of Participants Achieving a Validated Investigator Global Assessment (vIGA) 0 or 1 Score and a Reduction From Baseline of >= 2 Points
Baseline (Day 1) and Week 12
Double-blind Treatment Period: Percent Change in Weekly Peak Pruritus Numerical Rating Scale (NRS) From an Itch Daily Diary
Baseline (Day 1) and Week 12
Double-blind Treatment Period: Percentage of Participants With Improvement (Reduction) in Peak Pruritus NRS Greater Than or Equal to (>=)3 From an Itch Daily Diary
Baseline (Day 1) and Week 12
Double-blind Treatment Period: Percentage of Participants Achieving EASI-50
Baseline (Day 1) and Week 12
- +11 more secondary outcomes
Study Arms (4)
12-Week Double-Blind Treatment Period: Etrasimod 1 milligrams (mg)
EXPERIMENTAL12-Week Double-Blind Treatment Period: Etrasimod 2 mg
EXPERIMENTAL12-Week Double-Blind Treatment Period: Placebo
PLACEBO COMPARATOR52-Week Open-Label Extension Period: Etrasimod 2 mg
EXPERIMENTALInterventions
Etrasimod 1 mg tablet taken by mouth, once daily
Etrasimod 2 mg tablet taken by mouth, once daily.
Etrasimod matching placebo tablet by mouth, once daily.
Eligibility Criteria
You may qualify if:
- Participants with chronic atopic dermatitis, defined by Hanifin and Rajka criteria, that has been present for at least 1 year prior to the Screening Visit
- Participants with Eczema Area and Severity Index (EASI) ≥ 12 at the Screening Visit and ≥ 16 at the Baseline Visit
- Participants with validated Investigator's Global Assessment (vIGA) score ≥ 3 (on the 0 to 4 vIGA scale, in which 3 = moderate and 4 = severe) involvement at the Screening and Baseline visits
You may not qualify if:
- Presence of skin comorbidities that would interfere with study assessments of the underlying disease.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (38)
Noble Clinical Research
Tucson, Arizona, 85704, United States
Hope Clinical Research
Canoga Park, California, 91303, United States
First OC Dermatology
Fountain Valley, California, 92708, United States
Marvel Research LLC
Huntington Beach, California, 92647, United States
ADVA Clinical Research, Inc
Inglewood, California, 90301, United States
Providence Clinical Research
North Hollywood, California, 91606, United States
TCR Medical Corporation
San Diego, California, 92123, United States
Clinical Research of West Florida
Clearwater, Florida, 33765, United States
Prohealth Research Center
Doral, Florida, 33166, United States
Aby's New Generation Research, Inc.
Hialeah, Florida, 33016, United States
Skin Care Research, LLC
Hollywood, Florida, 33021, United States
Advanced Research Institute of Miami LLC
Homestead, Florida, 33030, United States
Amber Pediatrics Research, LLC
Homestead, Florida, 33030, United States
South Miami Medical & Research Group. Inc
Miami, Florida, 33155, United States
Amber Pediatrics Research, LLC
Miami, Florida, 33169, United States
Skin Research of South Florida
Miami, Florida, 33173, United States
Amber Clinical Research, LLC
Miami Shores, Florida, 33138, United States
IMA Clinical Research, LLC
St. Petersburg, Florida, 33709, United States
Clinical Research of West Florida, Inc.
Tampa, Florida, 33603, United States
Rophe Adult and Pediatric Medicine/SKYCRNG
Union City, Georgia, 30291, United States
Skin Sciences PLLC
Louisville, Kentucky, 40217, United States
Quinn Healthcare/SKYCRNG
Ridgeland, Mississippi, 39157, United States
Quality Clinical Research Inc
Omaha, Nebraska, 68114, United States
Excel Clinical Research
Las Vegas, Nevada, 89109, United States
Greenwich Village Dermatology
New York, New York, 10012, United States
ODRC Enterprises, LLC dba Oregon Dermatology and Research Center
Portland, Oregon, 97210, United States
Spartanburg Medical Research
Spartanburg, South Carolina, 29369, United States
Health Concepts
Rapid City, South Dakota, 57702, United States
Gadolin Research
Beaumont, Texas, 77702, United States
Modern Research Associates, PLLC
Dallas, Texas, 75231, United States
FMC Science
Georgetown, Texas, 78626, United States
FMC Science
Lampasas, Texas, 76550, United States
Alliance for Multispecialty Research
Norfolk, Virginia, 23507, United States
Clinical Research Partners, LLC
Richmond, Virginia, 23220, United States
Premier Clinical Research
Spokane, Washington, 99202, United States
Premier Specialists PTY LTD
Kogarah, New South Wales, 2217, Australia
Sinclair Dermatology
East Melbourne, Victoria, 3002, Australia
Diex Recherche Sherbrooke Inc.
Sherbrooke, Quebec, J1L 0H8, Canada
Related Publications (1)
Dubinsky MC, Wu J, McDonnell A, Lazin K, Goetsch M, Branquinho D, Modesto I, Armuzzi A. Low Incidence of Macular Edema and Other Ocular Events in the Etrasimod Development Program. J Crohns Colitis. 2025 May 8;19(5):jjae173. doi: 10.1093/ecco-jcc/jjae173.
PMID: 39575597DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Arena CT.gov Administrator
- Organization
- Arena Pharmaceuticals, Inc.
Study Officials
- STUDY DIRECTOR
Arena CT.gov Administrator
Arena Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 12, 2019
First Posted
November 14, 2019
Study Start
October 4, 2019
Primary Completion
September 9, 2020
Study Completion
October 11, 2021
Last Updated
November 4, 2022
Results First Posted
November 4, 2022
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will not share