Actively Recruiting
An Observational Study of Etrasimod in Adult Patients With Moderate to Severe Ulcerative Colitis
Led by Pfizer · Updated on 2026-04-28
300
Participants Needed
22
Research Sites
198 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this observational study is to learn about the effects of etrasimod as a treatment for adult patients with moderate to severe ulcerative colitis. Patients will be treated according to standard of care and will only be included in the study if etrasimod is the best treatment of choice according to the physician and they have not previously taken etrasimod. All patients will be prescribed etrasimod according to standard of care. Tests and doctor visits will be conducted according to standard of care with the exception of health questionnaires about ulcerative colitis symptoms. These questionnaires will be completed by patients at various timepoints during the study using their mobile phone, tablet, or computer. The study is 52 weeks with 28 days of safety follow up. The effects of etrasimod will be analyzed for each patient comparing their disease activity prior to the start of etrasimod.
CONDITIONS
Official Title
An Observational Study of Etrasimod in Adult Patients With Moderate to Severe Ulcerative Colitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older and younger than 65 years at baseline
- Confirmed diagnosis of ulcerative colitis with moderate to severe activity
- Signed informed consent indicating understanding of the study
You will not qualify if you...
- Signs suggesting Crohn's disease
- Severe extensive colitis with likely need for hospitalization or surgery within 12 weeks
- Current acute severe ulcerative colitis, fulminant colitis, or toxic megacolon
- Presence of a stoma or planned ulcerative colitis surgery requiring hospitalization
- Prior use of etrasimod or participation in etrasimod clinical trials
- Use of methotrexate, thiopurines, biologics, JAK inhibitors (filgotinib, tofacitinib, upadacitinib), or other S1P receptor modulators
- Unwillingness or inability to use the web-based tool for symptom questionnaires on a personal device
- Investigator site staff, Pfizer employees involved in the study, their supervised staff, or family members
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 22 locations
1
Reddy GI Associates
Mesa, Arizona, United States, 85206
Actively Recruiting
2
Scripps Clinic Torrey Pines
La Jolla, California, United States, 92037
Actively Recruiting
3
United Medical Doctors
Los Alamitos, California, United States, 90720
Not Yet Recruiting
4
Rocky Mountain Gastroenterology
Littleton, Colorado, United States, 80120
Actively Recruiting
5
Gastro Florida
Lutz, Florida, United States, 33558
Terminated
6
Orlando Health/Digestive Health Institute
Orlando, Florida, United States, 32806
Not Yet Recruiting
7
Rush University Medical Center
Chicago, Illinois, United States, 60612
Actively Recruiting
8
MGG Group Co., Inc., Chevy Chase Clinical Research
Chevy Chase, Maryland, United States, 20815
Actively Recruiting
9
Woodholme Gastroenterology Associates PA
Glen Burnie, Maryland, United States, 21061
Actively Recruiting
10
NYU Langone Health
New York, New York, United States, 10016
Actively Recruiting
11
Lenox Hill Hospital, Northwell Health
New York, New York, United States, 10075
Actively Recruiting
12
University of North Carolina at Chapel Hill, Division of Gastroenterology and Hepatology
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
13
OnSite Clinical Solutions, LLC
Charlotte, North Carolina, United States, 28211
Actively Recruiting
14
University of Cincinnati College of Medicine
Cincinnati, Ohio, United States, 45267
Actively Recruiting
15
Gastro Intestinal Research Institute of Northern Ohio, LLC
Westlake, Ohio, United States, 44145
Actively Recruiting
16
Medical University of South Carolina (MUSC)
Charleston, South Carolina, United States, 29425
Actively Recruiting
17
Houston Endoscopy & Research Center
Houston, Texas, United States, 77079
Actively Recruiting
18
BI Research Center
Houston, Texas, United States, 77084
Actively Recruiting
19
Brooke Army Medical center
San Antonio, Texas, United States, 78234
Not Yet Recruiting
20
GI Alliance Research
Southlake, Texas, United States, 76092
Actively Recruiting
21
Washington Gastroenterology
Tacoma, Washington, United States, 98405
Actively Recruiting
22
WVU Medicine J.W Ruby Memorial Hospital
Morgantown, West Virginia, United States, 26505
Actively Recruiting
Research Team
P
Pfizer CT.gov Call Center
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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