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An Observational Study of Etrasimod in Adult Patients With Moderate to Severe Ulcerative Colitis
NCT06398626 · Pfizer
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
A Multi-Center, Prospective, Non-Interventional Study of Real-World Effectiveness of Etrasimod in Patients With Ulcerative Colitis (ENDEAVOUR-UC)
About this study
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 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 design
Enrollment target: 300 participants
Age groups: adult
Timeline
Starts: 2024-09-17
Estimated completion: 2028-07-07
Last updated: 2025-12-08
Interventions
Drug: Etrasimod
Primary outcomes
- • Proportion of patients with symptomatic remission (Week 12)
Sponsor
Pfizer · industry
Contacts & investigators
ContactPfizer CT.gov Call Center · contact · ClinicalTrials.gov_Inquiries@pfizer.com · 1-800-718-1021
InvestigatorPfizer CT.gov Call Center · study_director, Pfizer
All locations (22)
Reddy GI AssociatesRecruiting
Mesa, Arizona, United States
Scripps Clinic Torrey PinesNot Yet Recruiting
La Jolla, California, United States
United Medical DoctorsNot Yet Recruiting
Los Alamitos, California, United States
Amicis Research CenterRecruiting
Valencia, California, United States
Rocky Mountain GastroenterologyRecruiting
Littleton, Colorado, United States
Gastro FloridaTerminated
Lutz, Florida, United States
Orlando Health/Digestive Health InstituteNot Yet Recruiting
Orlando, Florida, United States
Best Choice Medical Research ServiceRecruiting
Pembroke Pines, Florida, United States
University of South FloridaNot Yet Recruiting
Tampa, Florida, United States
MGG Group Co., Inc., Chevy Chase Clinical ResearchRecruiting
Chevy Chase, Maryland, United States
Woodholme Gastroenterology Associates PARecruiting
Glen Burnie, Maryland, United States
NYU Langone HealthRecruiting
New York, New York, United States
Lenox Hill Hospital, Northwell HealthRecruiting
New York, New York, United States
University of North Carolina at Chapel Hill, Division of Gastroenterology and HepatologyRecruiting
Chapel Hill, North Carolina, United States
University of Cincinnati College of MedicineRecruiting
Cincinnati, Ohio, United States
Gastro Intestinal Research Institute of Northern Ohio, LLCNot Yet Recruiting
Westlake, Ohio, United States
Houston Endoscopy & Research CenterRecruiting
Houston, Texas, United States
BI Research CenterRecruiting
Houston, Texas, United States
Brooke Army Medical centerNot Yet Recruiting
San Antonio, Texas, United States
GI Alliance ResearchRecruiting
Southlake, Texas, United States
Washington GastroenterologyRecruiting
Tacoma, Washington, United States
WVU Medicine J.W Ruby Memorial HospitalNot Yet Recruiting
Morgantown, West Virginia, United States