Not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.
PSC Trial Watch
UCRecruiting

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

Observational · No treatment assigned · 28 sites · Pfizer

Official record & contacts on ClinicalTrials.gov ↗

In plain English

What this trial is testing

Condition(s) listed: Colitis, Ulcerative. This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.

Who can join

Some of the main requirements, copied from the record:

There are also 11 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.

What's involved

Main thing being measured

In the researchers’ words

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.

This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.

Questions to ask your doctor and the trial team

Official details

StatusRecruiting
PhaseObservational
Study typeObservational
ConditionsColitis, Ulcerative
Lead sponsorPfizer
Enrollment300 (estimated)
Start date2024-09-17
Primary completion (est.)2027-10-01
First posted2024-05-03
Last updated2026-07-09
Official titleA Multi-Center, Prospective, Non-Interventional Study of Real-World Effectiveness of Etrasimod in Patients With Ulcerative Colitis (ENDEAVOUR-UC)
ClinicalTrials.gov IDNCT06398626

Interventions

Full eligibility criteria (from the record)
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

Locations (28)

Show all 28 sites
SiteCityCountrySite status
Reddy GI AssociatesMesa, ArizonaUnited StatesRecruiting
Scripps Clinic Torrey PinesLa Jolla, CaliforniaUnited StatesRecruiting
United Medical DoctorsLos Alamitos, CaliforniaUnited StatesRecruiting
United Medical DoctorsLos Alamitos, CaliforniaUnited StatesNot yet recruiting
Rocky Mountain GastroenterologyLittleton, ColoradoUnited StatesRecruiting
Digestive and Liver Center of Florida KissimmeeKissimmee, FloridaUnited StatesRecruiting
Gastro FloridaLutz, FloridaUnited StatesTerminated
Orlando Health/Digestive Health InstituteOrlando, FloridaUnited StatesNot yet recruiting
Feinberg School of Medicine Northwestern UniversityChicago, IllinoisUnited StatesRecruiting
Rush University Medical CenterChicago, IllinoisUnited StatesRecruiting
Suburban Gastroenterology LtdNaperville, IllinoisUnited StatesRecruiting
MGG Group Co., Inc., Chevy Chase Clinical ResearchChevy Chase, MarylandUnited StatesRecruiting
Woodholme Gastroenterology Associates PAGlen Burnie, MarylandUnited StatesRecruiting
Virtua HealthMarlton, New JerseyUnited StatesRecruiting
NYU Langone HealthNew York, New YorkUnited StatesRecruiting
Lenox Hill Hospital, Northwell HealthNew York, New YorkUnited StatesRecruiting
University of North Carolina at Chapel Hill, Division of Gastroenterology and HepatologyChapel Hill, North CarolinaUnited StatesRecruiting
OnSite Clinical Solutions, LLCCharlotte, North CarolinaUnited StatesRecruiting
University of Cincinnati College of MedicineCincinnati, OhioUnited StatesRecruiting
Gastro Intestinal Research Institute of Northern Ohio, LLCWestlake, OhioUnited StatesRecruiting
Medical University of South Carolina (MUSC)Charleston, South CarolinaUnited StatesRecruiting
Houston Endoscopy & Research CenterHouston, TexasUnited StatesRecruiting
BI Research CenterHouston, TexasUnited StatesRecruiting
Brooke Army Medical centerSan Antonio, TexasUnited StatesRecruiting
Brooke Army Medical centerSan Antonio, TexasUnited StatesNot yet recruiting
GI Alliance ResearchSouthlake, TexasUnited StatesRecruiting
Washington GastroenterologyTacoma, WashingtonUnited StatesRecruiting
WVU Medicine J.W Ruby Memorial HospitalMorgantown, West VirginiaUnited StatesRecruiting

For contacts at each site, use the official record.

Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.