Recruiting

Etrasimod

Sponsor:

Pfizer

Code:

NCT06398626

Conditions

Colitis, Ulcerative

Eligibility Criteria

Sex: All

Age: 18 - 64

Healthy Volunteers: Not accepted

Interventions

Etrasimod

Study Details

Brief summary:

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

Colitis, Ulcerative

Study ID

NCT06398626

Start date

Sep 17, 2024

Status verified date

Jul, 2026

Completion date

Jul 7, 2028

Anticipated

Primary completion date

Oct 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 64

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Age ≥ 18 years and < 65 years at baseline
2. Patients with confirmed diagnosis of UC who are prescribed etrasimod for moderately to severely active UC
3. Evidence of a personally signed and dated ICD indicating that the patient (or a legally acceptable representative)has been informed of all pertinent aspects of the study

Exclusion Criteria:

1. The presence of clinical findings suggestive of Crohn's disease
2. Severe extensive colitis evidenced by:

1. Physician judgement that the patient is likely to require hospitalization for medical or surgical intervention of any kind for UC (e.g., colectomy) within 12 weeks
2. Current evidence of acute severe UC, fulminant colitis, or toxic megacolon
3. Patients with a stoma or planned UC surgical intervention requiring hospitalization
4. Prior/Concomitant Therapy:

1. Any previous exposure to etrasimod, including participation in the etrasimod clinical program
2. Any co-medication with one of the following conventional therapies: methotrexate or a thiopurine (azathioprine, mercaptopurine, or tioguanine)
3. Any co-medication with one of the following advanced therapies for UC: biologics (a TNF, integrin or cytokine antagonist; JAKi \[filgotinib, tofacitinib, or upadacitinib\]) or with any other S1P receptor modulator
5. Unwillingness or inability to download the web-based tool to complete ePROs on a personal device or not capable of using the web-based tool
6. Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family

Study Design

Enrollment

300 participants

Anticipated

Interventions and Outcome Measures

Arms

Adult patients with ulcerative colitis taking etrasimod

Interventions

Etrasimod

As provided in real world practice

Primary outcome measure

  • Proportion of patients with symptomatic remission [ Time Frame: Week 12 ]

Central Contacts and Locations

Central contacts

Locations

Reddy GI Associates

Recruiting

Mesa, Arizona, United States, 85206

Scripps Clinic Torrey Pines

Recruiting

La Jolla, California, United States, 92037

United Medical Doctors

Recruiting

Los Alamitos, California, United States, 90720

Rocky Mountain Gastroenterology

Recruiting

Littleton, Colorado, United States, 80120

Digestive and Liver Center of Florida Kissimmee

Recruiting

Kissimmee, Florida, United States, 34741

Feinberg School of Medicine Northwestern University

Recruiting

Chicago, Illinois, United States, 60611

Rush University Medical Center

Recruiting

Chicago, Illinois, United States, 60612

Suburban Gastroenterology Ltd

Recruiting

Naperville, Illinois, United States, 60540

MGG Group Co., Inc., Chevy Chase Clinical Research

Recruiting

Chevy Chase, Maryland, United States, 20815

Woodholme Gastroenterology Associates PA

Recruiting

Glen Burnie, Maryland, United States, 21061

Virtua Health

Recruiting

Marlton, New Jersey, United States, 08053

NYU Langone Health

Recruiting

New York, New York, United States, 10016

Lenox Hill Hospital, Northwell Health

Recruiting

New York, New York, United States, 10075

University of North Carolina at Chapel Hill, Division of Gastroenterology and Hepatology

Recruiting

Chapel Hill, North Carolina, United States, 27599

OnSite Clinical Solutions, LLC

Recruiting

Charlotte, North Carolina, United States, 28211

University of Cincinnati College of Medicine

Recruiting

Cincinnati, Ohio, United States, 45267

Gastro Intestinal Research Institute of Northern Ohio, LLC

Recruiting

Westlake, Ohio, United States, 44145

Medical University of South Carolina (MUSC)

Recruiting

Charleston, South Carolina, United States, 29425

Houston Endoscopy & Research Center

Recruiting

Houston, Texas, United States, 77079

BI Research Center

Recruiting

Houston, Texas, United States, 77084

Brooke Army Medical center

Recruiting

San Antonio, Texas, United States, 78234

GI Alliance Research

Recruiting

Southlake, Texas, United States, 76092

Washington Gastroenterology

Recruiting

Tacoma, Washington, United States, 98405

WVU Medicine J.W Ruby Memorial Hospital

Recruiting

Morgantown, West Virginia, United States, 26505

More Information

Sponsor

Pfizer

Last update posted

Jul 9, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Pfizer on 2026-07-09.