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NCT06294925: EFFECT-UC
A Study to Learn About the Effectiveness of Etrasimod in People With Ulcerative Colitis
trial testing Etrasimod in Colitis, Ulcerative in 360 participants. Currently enrolling.
30 June 2026
Quick facts
| Lead sponsor | Pfizer |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 360 |
| Start date | 8 May 2024 |
| Primary completion | 30 June 2026 |
| Estimated completion | 30 June 2026 |
| Sites | 34 locations across Germany, United Kingdom, Canada |
Drugs / interventions tested
- Etrasimod (ETRASIMOD) — full drug profile →
Conditions studied
- Colitis, Ulcerative — all drugs for Colitis, Ulcerative →
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):
-
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 -
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 -
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:
- PubMed search for NCT06294925
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Etrasimod
Trials testing the same drug.
- NCT07470879 — A Study of How the Medicine Called "Etrasimod" Works in Children With the Gut Disease Called Ulcerative Colitis · Phase 2 · not yet recruiting
- NCT07153159 — A Study to Learn How the Study Medicine Called Etrasimod is Taken up Into Blood and Breastmilk of Healthy Breastfeeding · Phase 1 · recruiting
- NCT06398626 — An Observational Study of Etrasimod in Adult Patients With Moderate to Severe Ulcerative Colitis · recruiting
- NCT05287126 — A Study to Evaluate Etrasimod Treatment in Adolescents With Ulcerative Colitis · Phase 2 · recruiting
- NCT05061446 — Etrasimod Dose-Ranging Versus Placebo as Induction Therapy Study in Adult Japanese Subjects With Moderately to Severely · Phase 2 · completed
Other recruiting trials for Colitis, Ulcerative
Currently open trials in the same condition.
- NCT07302360 — A Real-World Study of Guselkumab in Chinese Participants With Ulcerative Colitis · recruiting
- NCT07242248 — A Study to Observe Real-world Evidence of Guselkumab Treatment in Participants With Ulcerative Colitis and Crohn's Disea · recruiting
- NCT07196748 — A Protocol of Icotrokinra Therapy in Adult and Adolescent Participants With Moderately to Severely Active Ulcerative Col · Phase 3 · recruiting
- NCT07102368 — A Study to Generate Real-world Evidence of Guselkumab Effectiveness in Inflammatory Bowel Disease in Germany · recruiting
- NCT06651281 — Extension Study of Long-term Safety and Efficacy of Tulisokibart in Participants With Crohn's Disease or Ulcerative Coli · Phase 3 · recruiting
Other Pfizer trials
Trials by the same sponsor.
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- NCT06864585 — A Study to Learn About the Study Medicine - Zavicefta in Patients With Sepsis or Loss of Kidney Function in Japan · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06294925 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Pfizer
- Last refreshed: 30 March 2026
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