Fact CheckerSign in

NCT06398626Recruiting

An Observational Study of Etrasimod in Adult Patients With Moderate to Severe Ulcerative Colitis

A Multi-Center, Prospective, Non-Interventional Study of Real-World Effectiveness of Etrasimod in Patients With Ulcerative Colitis (ENDEAVOUR-UC)

Source: ClinicalTrials.gov · Last updated 26 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
300 (estimated)
First submitted
30 Apr 2024
Start date
17 Sept 2024
Primary completion date
1 Oct 2027
Lead sponsor
Pfizer
NCT number
NCT06398626

What you commit to

  • Study type: Observational
  • Planned participants: 300
  • From 17 Sept 2024 to the primary completion date, 1 Oct 2027
  • 26 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Severe extensive colitis evidenced by:
    • 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
    • Current evidence of acute severe UC, fulminant colitis, or toxic megacolon
  • Patients with a stoma or planned UC surgical intervention requiring hospitalization
  • Prior/Concomitant Therapy:
    • Any previous exposure to etrasimod, including participation in the etrasimod clinical program
    • Any co-medication with one of the following conventional therapies: methotrexate or a thiopurine (azathioprine, mercaptopurine, or tioguanine)
    • 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

Other illness

  • The presence of clinical findings suggestive of Crohn's disease

Other

  • 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
  • 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

Who the study is looking for

  • Age ≥ 18 years and \< 65 years at baseline
  • Patients with confirmed diagnosis of UC who are prescribed etrasimod for moderately to severely active UC
  • 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

Age in the registry: 18 years to 64 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (26)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of North Carolina at Chapel Hill, Division of Gastroenterology and Hepatology
Coordinator of this site? Confirm its status
Chapel HillUnited StatesRecruiting
Medical University of South Carolina (MUSC)
Coordinator of this site? Confirm its status
CharlestonUnited StatesRecruiting
Onsite Clinical Solutions, LLC
Coordinator of this site? Confirm its status
CharlotteUnited StatesRecruiting
MGG Group Co., Inc., Chevy Chase Clinical Research
Coordinator of this site? Confirm its status
Chevy ChaseUnited StatesRecruiting
Feinberg School of Medicine Northwestern University
Coordinator of this site? Confirm its status
ChicagoUnited StatesRecruiting
Rush University Medical Center
Coordinator of this site? Confirm its status
ChicagoUnited StatesRecruiting
University of Cincinnati College of Medicine
Coordinator of this site? Confirm its status
CincinnatiUnited StatesRecruiting
Woodholme Gastroenterology Associates PA
Coordinator of this site? Confirm its status
Glen BurnieUnited StatesRecruiting
BI Research Center
Coordinator of this site? Confirm its status
HoustonUnited StatesRecruiting
Houston Endoscopy & Research Center
Coordinator of this site? Confirm its status
HoustonUnited StatesRecruiting
Digestive and Liver Center of Florida Kissimmee
Coordinator of this site? Confirm its status
KissimmeeUnited StatesRecruiting
Scripps Clinic Torrey Pines
Coordinator of this site? Confirm its status
La JollaUnited StatesRecruiting
Rocky Mountain Gastroenterology
Coordinator of this site? Confirm its status
LittletonUnited StatesRecruiting
United Medical Doctors
Coordinator of this site? Confirm its status
Los AlamitosUnited StatesNot yet recruiting
Gastro Florida
Coordinator of this site? Confirm its status
LutzUnited StatesTerminated
Virtua Health
Coordinator of this site? Confirm its status
MarltonUnited StatesRecruiting
Reddy GI Associates
Coordinator of this site? Confirm its status
MesaUnited StatesRecruiting
WVU Medicine J.W Ruby Memorial Hospital
Coordinator of this site? Confirm its status
MorgantownUnited StatesRecruiting
Suburban Gastroenterology Ltd
Coordinator of this site? Confirm its status
NapervilleUnited StatesRecruiting
NYU Langone Health
Coordinator of this site? Confirm its status
New YorkUnited StatesRecruiting
Lenox Hill Hospital | Northwell Health
Coordinator of this site? Confirm its status
New YorkUnited StatesRecruiting
Orlando Health Digestive Health Institute
Coordinator of this site? Confirm its status
OrlandoUnited StatesNot yet recruiting
Brooke Army Medical Center
Coordinator of this site? Confirm its status
San AntonioUnited StatesRecruiting
GI Alliance Research
Coordinator of this site? Confirm its status
SouthlakeUnited StatesRecruiting
Washington Gastroenterology
Coordinator of this site? Confirm its status
TacomaUnited StatesRecruiting
Gastro Intestinal Research Institute of Northern Ohio, LLC
Coordinator of this site? Confirm its status
WestlakeUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.