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

Last updated: November 18, 2024
Sponsor: Pfizer
Overall Status: Active - Recruiting

Phase

N/A

Condition

Crohn's Disease

Inflammatory Bowel 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 has beeninformed of all pertinent aspects of the study

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:
September 15, 2027

Connect with a study center

  • Reddy GI Associates

    Mesa, Arizona 85206
    United States

    Active - Recruiting

  • Amicis Research Center

    Valencia, California 91355
    United States

    Active - Recruiting

  • Rocky Mountain Gastroenterology

    Littleton, Colorado 80120
    United States

    Site Not Available

  • Gastro Florida

    Clearwater, Florida 33756
    United States

    Active - Recruiting

  • Gastro Florida

    Lutz, Florida 33558
    United States

    Active - Recruiting

  • Best Choice Medical Research Service

    Pembroke Pines, Florida 33024
    United States

    Active - Recruiting

  • EBGS Clinical Research Center

    Snellville, Georgia 30078
    United States

    Active - Recruiting

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

    Chevy Chase, Maryland 20815
    United States

    Active - Recruiting

  • Woodholme Gastroenterology Associates PA

    Glen Burnie, Maryland 21061
    United States

    Active - Recruiting

  • NYU Langone Health

    New York, New York 10016
    United States

    Active - Recruiting

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

    Chapel Hill, North Carolina 27599
    United States

    Active - Recruiting

  • Hightower Clinical Trial Services

    Oklahoma City, Oklahoma 73102
    United States

    Active - Recruiting

  • BI Research Center

    Houston, Texas 77084
    United States

    Site Not Available

  • Washington Gastroenterology

    Tacoma, Washington 98405
    United States

    Active - Recruiting

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