A Study to Assess the Safety and Efficacy of Etrasimod in Subjects With Moderate-to-Severe Atopic Dermatitis
NCT ID: NCT04162769
Last Updated: 2022-11-04
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
140 participants
INTERVENTIONAL
2019-10-04
2021-10-11
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study to Learn About the Study Medicine Etrasimod in Adults With Moderate to Severe Atopic Dermatitis (AD) Who Have Already Tried Treatments Taken by Mouth or by Injection
NCT05732454
A Study to Evaluate the Effectiveness and Safety of Treatments, Either Alone or in Combination, for the Treatment of Moderate to Severe Atopic Dermatitis
NCT06718101
Tralokinumab Monotherapy for Moderate to Severe Atopic Dermatitis - ECZTRA 1 (ECZema TRAlokinumab Trial no. 1)
NCT03131648
Phase 2b Study to Evaluate the Efficacy and Safety of ISB 830 in Adults With Moderate to Severe Atopic Dermatitis
NCT03568162
Study of TER-101 Topical Ointment in Subjects With Atopic Dermatitis
NCT04753034
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
12-Week Double-Blind Treatment Period: Etrasimod 1 milligrams (mg)
Etrasimod 1 mg
Etrasimod 1 mg tablet taken by mouth, once daily
12-Week Double-Blind Treatment Period: Etrasimod 2 mg
Etrasimod 2 mg
Etrasimod 2 mg tablet taken by mouth, once daily.
12-Week Double-Blind Treatment Period: Placebo
Etrasimod matching placebo
Etrasimod matching placebo tablet by mouth, once daily.
52-Week Open-Label Extension Period: Etrasimod 2 mg
Etrasimod 2 mg
Etrasimod 2 mg tablet taken by mouth, once daily.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Etrasimod 1 mg
Etrasimod 1 mg tablet taken by mouth, once daily
Etrasimod 2 mg
Etrasimod 2 mg tablet taken by mouth, once daily.
Etrasimod matching placebo
Etrasimod matching placebo tablet by mouth, once daily.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
18 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Arena Pharmaceuticals
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Arena CT.gov Administrator
Role: STUDY_DIRECTOR
Arena Pharmaceuticals
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Noble Clinical Research
Tucson, Arizona, United States
Hope Clinical Research
Canoga Park, California, United States
First OC Dermatology
Fountain Valley, California, United States
Marvel Research LLC
Huntington Beach, California, United States
ADVA Clinical Research, Inc
Inglewood, California, United States
Providence Clinical Research
North Hollywood, California, United States
TCR Medical Corporation
San Diego, California, United States
Clinical Research of West Florida
Clearwater, Florida, United States
Prohealth Research Center
Doral, Florida, United States
Aby's New Generation Research, Inc.
Hialeah, Florida, United States
Skin Care Research, LLC
Hollywood, Florida, United States
Advanced Research Institute of Miami LLC
Homestead, Florida, United States
Amber Pediatrics Research, LLC
Homestead, Florida, United States
South Miami Medical & Research Group. Inc
Miami, Florida, United States
Amber Pediatrics Research, LLC
Miami, Florida, United States
Skin Research of South Florida
Miami, Florida, United States
Amber Clinical Research, LLC
Miami Shores, Florida, United States
IMA Clinical Research, LLC
St. Petersburg, Florida, United States
Clinical Research of West Florida, Inc.
Tampa, Florida, United States
Rophe Adult and Pediatric Medicine/SKYCRNG
Union City, Georgia, United States
Skin Sciences PLLC
Louisville, Kentucky, United States
Quinn Healthcare/SKYCRNG
Ridgeland, Mississippi, United States
Quality Clinical Research Inc
Omaha, Nebraska, United States
Excel Clinical Research
Las Vegas, Nevada, United States
Greenwich Village Dermatology
New York, New York, United States
ODRC Enterprises, LLC dba Oregon Dermatology and Research Center
Portland, Oregon, United States
Spartanburg Medical Research
Spartanburg, South Carolina, United States
Health Concepts
Rapid City, South Dakota, United States
Gadolin Research
Beaumont, Texas, United States
Modern Research Associates, PLLC
Dallas, Texas, United States
FMC Science
Georgetown, Texas, United States
FMC Science
Lampasas, Texas, United States
Alliance for Multispecialty Research
Norfolk, Virginia, United States
Clinical Research Partners, LLC
Richmond, Virginia, United States
Premier Clinical Research
Spokane, Washington, United States
Premier Specialists PTY LTD
Kogarah, New South Wales, Australia
Sinclair Dermatology
East Melbourne, Victoria, Australia
Diex Recherche Sherbrooke Inc.
Sherbrooke, Quebec, Canada
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
APD334-201
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.