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NCT06294925: EFFECT-UC

A Study to Learn About the Effectiveness of Etrasimod in People With Ulcerative Colitis

Recruiting now Last updated 30 March 2026
What this trial tests

trial testing Etrasimod in Colitis, Ulcerative in 360 participants. Currently enrolling.

Timeline
8 May 2024
Primary endpoint
30 June 2026
30 June 2026

Quick facts

Lead sponsorPfizer
StatusRecruiting now
Study typeOBSERVATIONAL
Enrollment360
Start date8 May 2024
Primary completion30 June 2026
Estimated completion30 June 2026
Sites34 locations across Germany, United Kingdom, Canada

Drugs / interventions tested

Conditions studied

Sponsor

Pfizer — full company profile →

Who can join

Adults 18 to 64, any sex, with Colitis, Ulcerative. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this real world non-interventional study is to learn about the effects of etrasimod as treatment for 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 choice according to the treating physician. Additionally, patients have to be between 18 and 65 years of age and should not have taken etrasimod in the past. All patients will be prescribed etrasimod according to standard of care. Assessments will be conducted according to standard of care with the exception of health questionnaires which will be completed by the patients online on their own device. The study duration is 52 weeks with 28 days of safety follow-up. Patients will visit their treating physician as they would if they were not enrolled in the study. During the study duration, patients will be asked to complete health questionnaires on a regular basis either on their mobile phone, tablet or computer. The effects of etrasimod will be analyzed for each patient comparing to their disease activity prior to the start of etrasimod.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Targeting the Sphingosine-1-Phosphate Pathway: New Opportunities in Inflammatory Bowel Disease Management.
    Kitsou K, Kokkotis G, Rivera-Nieves J, Bamias G. · · 2024 · cited 22× · PMID 39322927 · DOI 10.1007/s40265-024-02094-5
  2. The Current Sphingosine 1 Phosphate Receptor Modulators in the Management of Ulcerative Colitis.
    Choon XY, Yeo JH, White C, Sharma E, et al · · 2025 · cited 3× · PMID 40429469 · DOI 10.3390/jcm14103475
  3. Effectiveness of etrasimod on disease activity and patient-reported outcomes in ulcerative colitis-EFFECT-UC: a non-interventional, multinational, prospective cohort study protocol.
    Moran GW, Radford SJ, Walsh A, Battat R, et al · · 2025 · PMID 41448713 · DOI 10.1136/bmjopen-2025-106141

Verify or expand the search:

Other trials of Etrasimod

Trials testing the same drug.

Other recruiting trials for Colitis, Ulcerative

Currently open trials in the same condition.

Other Pfizer trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06294925.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing