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Clinical Trials in the USA / NCT06398626
Recruiting Observational

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

NCT06398626 · tracked via the Priya Life Science USA tracker
Sponsor
Pfizer
Phase
Observational
Started
2024-09-17
Last updated
2026-07-09

Condition(s) studied

Colitis, Ulcerative

Investigational drug(s) / intervention(s)

Etrasimod

Etrasimod: As provided in real world practice

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

Sex
ALL
Min age
18 Years
Max age
64 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (28)

FacilityCityRegionStatus
Reddy GI Associates Mesa Arizona Recruiting
Scripps Clinic Torrey Pines La Jolla California Recruiting
United Medical Doctors Los Alamitos California Recruiting
United Medical Doctors Los Alamitos California Not Yet Recruiting
Rocky Mountain Gastroenterology Littleton Colorado Recruiting
Digestive and Liver Center of Florida Kissimmee Kissimmee Florida Recruiting
Gastro Florida Lutz Florida Terminated
Orlando Health/Digestive Health Institute Orlando Florida Not Yet Recruiting
Feinberg School of Medicine Northwestern University Chicago Illinois Recruiting
Rush University Medical Center Chicago Illinois Recruiting
Suburban Gastroenterology Ltd Naperville Illinois Recruiting
MGG Group Co., Inc., Chevy Chase Clinical Research Chevy Chase Maryland Recruiting
Woodholme Gastroenterology Associates PA Glen Burnie Maryland Recruiting
Virtua Health Marlton New Jersey Recruiting
NYU Langone Health New York New York Recruiting
Lenox Hill Hospital, Northwell Health New York New York Recruiting
University of North Carolina at Chapel Hill, Division of Gastroenterology and Hepatology Chapel Hill North Carolina Recruiting
OnSite Clinical Solutions, LLC Charlotte North Carolina Recruiting
University of Cincinnati College of Medicine Cincinnati Ohio Recruiting
Gastro Intestinal Research Institute of Northern Ohio, LLC Westlake Ohio Recruiting
Medical University of South Carolina (MUSC) Charleston South Carolina Recruiting
Houston Endoscopy & Research Center Houston Texas Recruiting
BI Research Center Houston Texas Recruiting
Brooke Army Medical center San Antonio Texas Recruiting
Brooke Army Medical center San Antonio Texas Not Yet Recruiting
GI Alliance Research Southlake Texas Recruiting
Washington Gastroenterology Tacoma Washington Recruiting
WVU Medicine J.W Ruby Memorial Hospital Morgantown West Virginia Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06398626 on ClinicalTrials.gov ↗ ← All trials in the USA