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

Pfizer

Status: Enrolling

Conditions: Colitis, Ulcerative

Treatments: Drug: Etrasimod

Study type: Observational

Funder types: Industry

Identifiers

NCT06398626

C5041047

ENDEAVOUR-UC (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

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 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

Trial design

300 participants in 1 patient group

Adult patients with ulcerative colitis taking etrasimod

Treatment:

Drug: Etrasimod