Observing the effects of etrasimod in adults 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)

This study is testing how well etrasimod works for adults with moderate to severe ulcerative colitis by tracking their symptoms over a year while they use the medication as part of their regular treatment.

Quick facts

• Study type: Observational
• Enrollment: 300 (estimated)
• Ages: 18 Years to 64 Years
• Sex: All
• Sponsor: Pfizer (industry)
• Drugs / interventions: filgotinib, tofacitinib, upadacitinib, methotrexate
• Locations: 22 sites (Mesa, Arizona and 21 other locations)
• Trial ID: NCT06398626 on ClinicalTrials.gov

What this trial studies

This observational study aims to evaluate the effects of etrasimod in adult patients diagnosed with moderate to severe ulcerative colitis. Participants will receive etrasimod as part of their standard care, and their disease activity will be monitored through health questionnaires completed via mobile devices at various timepoints. The study will last for 52 weeks, followed by a 28-day safety follow-up period, allowing researchers to analyze the impact of etrasimod on patients' symptoms compared to their condition before treatment. Inclusion in the study requires that etrasimod is deemed the best treatment option by the physician and that patients have not previously received this medication.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 65 with a confirmed diagnosis of moderate to severe ulcerative colitis who are being prescribed etrasimod.

Not a fit: Patients with Crohn's disease, severe extensive colitis, or those who have previously taken etrasimod will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the effectiveness of etrasimod for managing ulcerative colitis symptoms in adults.

How similar studies have performed: While this approach is observational, similar studies evaluating treatments for ulcerative colitis have shown promising results, indicating potential for success.

Eligibility criteria

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

Where this trial is running

Mesa, Arizona and 21 other locations

• Reddy GI Associates — Mesa, Arizona, United States (RECRUITING)
• Scripps Clinic Torrey Pines — La Jolla, California, United States (RECRUITING)
• United Medical Doctors — Los Alamitos, California, United States (NOT_YET_RECRUITING)
• Rocky Mountain Gastroenterology — Littleton, Colorado, United States (RECRUITING)
• Gastro Florida — Lutz, Florida, United States (TERMINATED)
• Orlando Health/Digestive Health Institute — Orlando, Florida, United States (NOT_YET_RECRUITING)
• Rush University Medical Center — Chicago, Illinois, United States (RECRUITING)
• MGG Group Co., Inc., Chevy Chase Clinical Research — Chevy Chase, Maryland, United States (RECRUITING)
• Woodholme Gastroenterology Associates PA — Glen Burnie, Maryland, United States (RECRUITING)
• NYU Langone Health — New York, New York, United States (RECRUITING)
• Lenox Hill Hospital, Northwell Health — New York, New York, United States (RECRUITING)
• University of North Carolina at Chapel Hill, Division of Gastroenterology and Hepatology — Chapel Hill, North Carolina, United States (RECRUITING)
• OnSite Clinical Solutions, LLC — Charlotte, North Carolina, United States (RECRUITING)
• University of Cincinnati College of Medicine — Cincinnati, Ohio, United States (RECRUITING)
• Gastro Intestinal Research Institute of Northern Ohio, LLC — Westlake, Ohio, United States (RECRUITING)
• Medical University of South Carolina (MUSC) — Charleston, South Carolina, United States (RECRUITING)
• Houston Endoscopy & Research Center — Houston, Texas, United States (RECRUITING)
• BI Research Center — Houston, Texas, United States (RECRUITING)
• Brooke Army Medical center — San Antonio, Texas, United States (NOT_YET_RECRUITING)
• GI Alliance Research — Southlake, Texas, United States (RECRUITING)
• Washington Gastroenterology — Tacoma, Washington, United States (RECRUITING)
• WVU Medicine J.W Ruby Memorial Hospital — Morgantown, West Virginia, United States (RECRUITING)

Study contacts

• Study coordinator: Pfizer CT.gov Call Center

Conditions: Colitis, Ulcerative