An Observational Study of Etrasimod in Adult Patients With Moderate to Severe Ulcerative Colitis (ENDEAVOUR-UC)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Colitis, Ulcerative
• Intervention / Treatment: Drug: Etrasimod

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Pfizer CT.gov Call Center; Phone Number: 1-800-718-1021; Email: ClinicalTrials.gov_Inquiries@pfizer.com

Study Locations

• United States
  • Arizona
    • Mesa, Arizona, United States, 85206
      • Recruiting
      • Reddy GI Associates
  • California
    • La Jolla, California, United States, 92037
      • Recruiting
      • Scripps Clinic Torrey Pines
    • Los Alamitos, California, United States, 90720
      • Not yet recruiting
      • United Medical Doctors
  • Colorado
    • Littleton, Colorado, United States, 80120
      • Recruiting
      • Rocky Mountain Gastroenterology
  • Florida
    • Lutz, Florida, United States, 33558
      • Terminated
      • Gastro Florida
    • Orlando, Florida, United States, 32806
      • Not yet recruiting
      • Orlando Health/Digestive Health Institute
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Recruiting
      • Rush University Medical Center
  • Maryland
    • Chevy Chase, Maryland, United States, 20815
      • Recruiting
      • MGG Group Co., Inc., Chevy Chase Clinical Research
    • Glen Burnie, Maryland, United States, 21061
      • Recruiting
      • Woodholme Gastroenterology Associates PA
  • New York
    • New York, New York, United States, 10016
      • Recruiting
      • NYU Langone Health
    • New York, New York, United States, 10075
      • Recruiting
      • Lenox Hill Hospital, Northwell Health
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • Recruiting
      • University of North Carolina at Chapel Hill, Division of Gastroenterology and Hepatology
    • Charlotte, North Carolina, United States, 28211
      • Recruiting
      • Onsite Clinical Solutions, LLC
  • Ohio
    • Cincinnati, Ohio, United States, 45267
      • Recruiting
      • University of Cincinnati College of Medicine
    • Westlake, Ohio, United States, 44145
      • Recruiting
      • Gastro Intestinal Research Institute of Northern Ohio, LLC
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Recruiting
      • Medical University of South Carolina (MUSC)
  • Texas
    • Houston, Texas, United States, 77084
      • Recruiting
      • BI Research Center
    • Houston, Texas, United States, 77079
      • Recruiting
      • Houston Endoscopy & Research Center
    • San Antonio, Texas, United States, 78234
      • Not yet recruiting
      • Brooke Army Medical Center
    • Southlake, Texas, United States, 76092
      • Recruiting
      • GI Alliance Research
  • Washington
    • Tacoma, Washington, United States, 98405
      • Recruiting
      • Washington Gastroenterology
  • West Virginia
    • Morgantown, West Virginia, United States, 26505
      • Recruiting
      • WVU Medicine J.W Ruby Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Eligible patients can be included in this study if their physician makes a clinical decision to treat them with etrasimod, as defined by the United States etrasimod prescribing information and independent from the decision to enroll the patient in this study.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Adult patients with ulcerative colitis taking etrasimod	Drug: Etrasimod; As provided in real world practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients with symptomatic remission	Symptomatic remission is defined as partial Modified Mayo Score (pMMS) stool frequency subscore (SFS) = 0 (or = 1 with a ≥ 1-point decrease from baseline) and (RBS) rectal bleeding subscore = 0	Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients with symptomatic remission	Symptomatic remission is defined as partial Modified Mayo Score (pMMS) stool frequency subscore (SFS) = 0 (or = 1 with a ≥ 1-point decrease from baseline) and (RBS) rectal bleeding subscore = 0	Weeks 24, 36, 52
Proportion of patients with symptomatic response	Symptomatic response defined as a decrease from baseline ≥ 30% in pMMS composite RBS and SFS	Weeks 12, 24, 36, 52
Proportion of patients with symptomatic response	Symptomatic response defined as a decrease from baseline ≥ 20% in pMMS composite RBS and SFS	Weeks 12, 24, 36, 52
Proportion of patients with clinical remission	Clinical remission is defined as a pMMS ≤ 2 points, with no individual subscores > 1 point.	Weeks 12, 24, 36, 52
Change from baseline in fatigue	Change from baseline in the Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue score Normalization of fatigue is defined as a FACIT Fatigue score ≥ 40.1	Weeks 12, 24, 36, 52
Change from baseline of bowel urgency	Change from baseline in bowel urgency on a 0 (no urgency) - 10 (worst possible urgency) numeric rating scale	Weeks 12, 24, 36, 52
Proportion of patients with a clinically meaningful improvement in bowel urgency	Clinically meaningful improvement in bowel urgency is defined as ≥ 3-point decrease from baseline among patients with baseline bowel urgency score ≥ 3	Weeks 12, 24, 36, 52
Proportion of patients in bowel urgency remission	Bowel urgency remission is defined as a bowel urgency score ≤ 1 among patients with a baseline bowel urgency score ≥ 3 and the overall population	Weeks 12, 24, 36, 52
Proportion of patients with complete bowel urgency remission	Complete bowel urgency remission is defined as a bowel urgency Numeric Rating Scale score = 0	Weeks 12, 24, 36, 52
Change from baseline in abdominal pain	Change from baseline in abdominal pain on a 0 (no pain) - 10 (pain as bad as can imagine) numeric rating scale	Weeks 12, 24, 36, 52
Proportion of patients with abdominal pain remission	Abdominal pain remission is defined as an abdominal pain Numeric Rating Scale score = 0	Weeks 12, 24, 36, 52
Proportion of patients with steroid-free symptomatic remission (among all patients and among patients in symptomatic remission)	Steroid-free symptomatic remission is defined as patients in symptomatic remission who did not take any corticosteroid treatment for 8 weeks prior to the visit/timepoint	Weeks 24, 36, 52
Proportion of patients with steroid-free clinical remission (among all patients and among patients in clinical remission)	Steroid-free clinical remission is defined as patients in clinical remission (using a pMMS) who did not take any corticosteroid treatment for 8 weeks prior to the visit/timepoint	Weeks 24, 36, 52

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): September 17, 2024
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): July 7, 2028

Study Registration Dates

• First Submitted: April 30, 2024
• First Submitted That Met QC Criteria: April 30, 2024
• First Posted (Actual): May 3, 2024

Study Record Updates

• Last Update Posted (Actual): April 28, 2026
• Last Update Submitted That Met QC Criteria: April 23, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Colitis; Colitis, Ulcerative; etrasimod
• Other Study ID Numbers: C5041047; ENDEAVOUR-UC (Other Identifier: Alias Study Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.