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
- Diseases
- Ulcerative colitis
- 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
Sites (26)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of North Carolina at Chapel Hill, Division of Gastroenterology and Hepatology Coordinator of this site? Confirm its status | Chapel Hill | United States | Recruiting |
| Medical University of South Carolina (MUSC) Coordinator of this site? Confirm its status | Charleston | United States | Recruiting |
| Onsite Clinical Solutions, LLC Coordinator of this site? Confirm its status | Charlotte | United States | Recruiting |
| MGG Group Co., Inc., Chevy Chase Clinical Research Coordinator of this site? Confirm its status | Chevy Chase | United States | Recruiting |
| Feinberg School of Medicine Northwestern University Coordinator of this site? Confirm its status | Chicago | United States | Recruiting |
| Rush University Medical Center Coordinator of this site? Confirm its status | Chicago | United States | Recruiting |
| University of Cincinnati College of Medicine Coordinator of this site? Confirm its status | Cincinnati | United States | Recruiting |
| Woodholme Gastroenterology Associates PA Coordinator of this site? Confirm its status | Glen Burnie | United States | Recruiting |
| BI Research Center Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| Houston Endoscopy & Research Center Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| Digestive and Liver Center of Florida Kissimmee Coordinator of this site? Confirm its status | Kissimmee | United States | Recruiting |
| Scripps Clinic Torrey Pines Coordinator of this site? Confirm its status | La Jolla | United States | Recruiting |
| Rocky Mountain Gastroenterology Coordinator of this site? Confirm its status | Littleton | United States | Recruiting |
| United Medical Doctors Coordinator of this site? Confirm its status | Los Alamitos | United States | Not yet recruiting |
| Gastro Florida Coordinator of this site? Confirm its status | Lutz | United States | Terminated |
| Virtua Health Coordinator of this site? Confirm its status | Marlton | United States | Recruiting |
| Reddy GI Associates Coordinator of this site? Confirm its status | Mesa | United States | Recruiting |
| WVU Medicine J.W Ruby Memorial Hospital Coordinator of this site? Confirm its status | Morgantown | United States | Recruiting |
| Suburban Gastroenterology Ltd Coordinator of this site? Confirm its status | Naperville | United States | Recruiting |
| NYU Langone Health Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Lenox Hill Hospital | Northwell Health Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Orlando Health Digestive Health Institute Coordinator of this site? Confirm its status | Orlando | United States | Not yet recruiting |
| Brooke Army Medical Center Coordinator of this site? Confirm its status | San Antonio | United States | Recruiting |
| GI Alliance Research Coordinator of this site? Confirm its status | Southlake | United States | Recruiting |
| Washington Gastroenterology Coordinator of this site? Confirm its status | Tacoma | United States | Recruiting |
| Gastro Intestinal Research Institute of Northern Ohio, LLC Coordinator of this site? Confirm its status | Westlake | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.