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

Last updated: December 4, 2025
Sponsor: Pfizer
Overall Status: Active - Recruiting

Phase

N/A

Condition

Inflammatory Bowel Disease

Crohn's Disease

Treatment

Etrasimod

Clinical Study ID

NCT06398626
C5041047
ENDEAVOUR-UC
  • Ages 18-64
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age ≥ 18 years and < 65 years at baseline

  2. Patients with confirmed diagnosis of UC who are prescribed etrasimod for moderatelyto severely active UC

  3. Evidence of a personally signed and dated ICD indicating that the patient (or alegally acceptable representative)has been informed of all pertinent aspects of thestudy

Exclusion

Exclusion Criteria:

  1. The presence of clinical findings suggestive of Crohn's disease

  2. Severe extensive colitis evidenced by:

  3. Physician judgement that the patient is likely to require hospitalization formedical or surgical intervention of any kind for UC (e.g., colectomy) within 12weeks

  4. Current evidence of acute severe UC, fulminant colitis, or toxic megacolon

  5. Patients with a stoma or planned UC surgical intervention requiring hospitalization

  6. Prior/Concomitant Therapy:

  7. Any previous exposure to etrasimod, including participation in the etrasimodclinical program

  8. Any co-medication with one of the following conventional therapies:methotrexate or a thiopurine (azathioprine, mercaptopurine, or tioguanine)

  9. 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

  10. Unwillingness or inability to download the web-based tool to complete ePROs on apersonal device or not capable of using the web-based tool

  11. Investigator site staff or Pfizer employees directly involved in the conduct of thestudy, site staff otherwise supervised by the investigator, and their respectivefamily

Study Design

Total Participants: 300
Treatment Group(s): 1
Primary Treatment: Etrasimod
Phase:
Study Start date:
September 17, 2024
Estimated Completion Date:
July 07, 2028

Connect with a study center

  • Reddy GI Associates

    Mesa, Arizona 85206
    United States

    Site Not Available

  • Reddy GI Associates

    Mesa 5304391, Arizona 5551752 85206
    United States

    Active - Recruiting

  • Amicis Research Center

    Valencia, California 91355
    United States

    Site Not Available

  • Scripps Clinic Torrey Pines

    La Jolla 5363943, California 5332921 92037
    United States

    Site Not Available

  • United Medical Doctors

    Los Alamitos 5368304, California 5332921 90720
    United States

    Site Not Available

  • Amicis Research Center

    Valencia 5405288, California 5332921 91355
    United States

    Active - Recruiting

  • Rocky Mountain Gastroenterology

    Littleton, Colorado 80120
    United States

    Site Not Available

  • Rocky Mountain Gastroenterology

    Littleton 5429032, Colorado 5417618 80120
    United States

    Active - Recruiting

  • Gastro Florida

    Clearwater, Florida 33756
    United States

    Site Not Available

  • Gastro Florida

    Lutz, Florida 33558
    United States

    Site Not Available

  • Best Choice Medical Research Service

    Pembroke Pines, Florida 33024
    United States

    Site Not Available

  • Gastro Florida

    Lutz 4163033, Florida 4155751 33558
    United States

    Terminated

  • Orlando Health/Digestive Health Institute

    Orlando 4167147, Florida 4155751 32806
    United States

    Site Not Available

  • Best Choice Medical Research Service

    Pembroke Pines 4168139, Florida 4155751 33024
    United States

    Active - Recruiting

  • University of South Florida

    Tampa 4174757, Florida 4155751 33612
    United States

    Site Not Available

  • EBGS Clinical Research Center

    Snellville, Georgia 30078
    United States

    Site Not Available

  • MGG Group Co., Inc., Chevy Chase Clinical Research

    Chevy Chase, Maryland 20815
    United States

    Site Not Available

  • Woodholme Gastroenterology Associates PA

    Glen Burnie, Maryland 21061
    United States

    Site Not Available

  • MGG Group Co., Inc., Chevy Chase Clinical Research

    Chevy Chase 4351335, Maryland 4361885 20815
    United States

    Active - Recruiting

  • Woodholme Gastroenterology Associates PA

    Glen Burnie 4356188, Maryland 4361885 21061
    United States

    Active - Recruiting

  • NYU Langone Health

    New York, New York 10016
    United States

    Site Not Available

  • Lenox Hill Hospital, Northwell Health

    New York 5128581, New York 5128638 10075
    United States

    Active - Recruiting

  • NYU Langone Health

    New York 5128581, New York 5128638 10016
    United States

    Active - Recruiting

  • University of North Carolina at Chapel Hill, Division of Gastroenterology and Hepatology

    Chapel Hill, North Carolina 27599
    United States

    Site Not Available

  • University of North Carolina at Chapel Hill, Division of Gastroenterology and Hepatology

    Chapel Hill 4460162, North Carolina 4482348 27599
    United States

    Active - Recruiting

  • University of Cincinnati College of Medicine

    Cincinnati 4508722, Ohio 5165418 45267
    United States

    Active - Recruiting

  • Gastro Intestinal Research Institute of Northern Ohio, LLC

    Westlake 5176517, Ohio 5165418 44145
    United States

    Site Not Available

  • Hightower Clinical Trial Services

    Oklahoma City, Oklahoma 73102
    United States

    Site Not Available

  • BI Research Center

    Houston, Texas 77084
    United States

    Site Not Available

  • BI Research Center

    Houston 4699066, Texas 4736286 77084
    United States

    Active - Recruiting

  • Houston Endoscopy & Research Center

    Houston 4699066, Texas 4736286 77079
    United States

    Active - Recruiting

  • Brooke Army Medical center

    San Antonio 4726206, Texas 4736286 78234
    United States

    Site Not Available

  • GI Alliance Research

    Southlake 4733313, Texas 4736286 76092
    United States

    Active - Recruiting

  • Washington Gastroenterology

    Tacoma, Washington 98405
    United States

    Site Not Available

  • Washington Gastroenterology

    Tacoma 5812944, Washington 5815135 98405
    United States

    Active - Recruiting

  • WVU Medicine J.W Ruby Memorial Hospital

    Morgantown 4815352, West Virginia 4826850 26505
    United States

    Site Not Available

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