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ACTIVE NOT RECRUITINGN/A

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

Sponsor: Pfizer

NCT ID: NCT06294925

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Health checks and monitoring — no treatment given
Type of study
Observational (no treatment given)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Etrasimod (drug)
How long the study runs
Study runs about 36 months (dates as stated)
About the drug or intervention
Etrasimod — drug: As provided in real world practice
Patient visit burden
Not specified by the sponsor
Type of study
Observing health over time
Ages
18 Years to 64 Years
Who
All
Number of participants
360
Started
2024-05-08
Last checked
2026-10

Plain English Summary

What is this study?

  • • Testing a new treatment for colitis, ulcerative
  • • Clinical study - 360 participants
  • • 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

Who can take part?

  • • Ages 18 Years to 64 Years
  • • Diagnosed with colitis, ulcerative

Where?

  • • Glasgow - NHS Greater Glasgow and Clyde
  • • Nottingham - Nottingham University Hospitals NHS Trust, Queens Medical Centre
  • • Oxford - Oxford University Hospitals NHS Foundation Trust
  • • Edinburgh - Western General Hospital
  • • +11 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

Colitis, Ulcerative

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years - 64 Years
  • Who can join: All genders

What the study is looking for

  • ✓Male and female patients ≥18 and \<65 years of age at baseline
  • ✓Evidence of a personally signed and dated agreement to take part document indicating that the patient has been informed of...

Who cannot take part

  • ✗Presence of clinical findings suggestive of Crohn's disease.
  • ✗Severe extensive colitis evidenced by:
  • ✗Physician judgement that the patient is likely to require hospitalization for medical or surgical intervention of...
  • ✗Current evidence of acute severe UC, fulminant colitis, or toxic megacolon 3. Patients with a stoma or planned UC...
  • ✗4\. Prior/Concomitant Therapy:
See the full criteria
Inclusion Criteria: * Male and female patients ≥18 and \<65 years of age at baseline * Patients with confirmed diagnosis of ulcerative colitis and who are prescribed etrasimod for moderately to severely active ulcerative colitis as per the product label independently of the decision to enroll a patient in this study. * Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study. Exclusion Criteria: * Presence of clinical findings suggestive of Crohn's disease. * 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 (eg, 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) or with any of the following advanced therapies for UC: biologics (a TNF, integrin or cytokine antagonist); JAK inhibitors (filgotinib, tofacitinib or upadacitinib) or with any other S1P receptor modulator. * Not owning a digital device with internet connection and/or not willing to complete health questionnaires on this device or not capable of using the health questionnaire collection tool. * 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.

Where Is This Study? (15 UK sites)

NHS Greater Glasgow and Clyde

Glasgow G4 0SF, United Kingdom

Hospital R&D contact (matched)

Radek Penar

radoslaw.penar@nhs.scotn/a

Nottingham University Hospitals NHS Trust, Queens Medical Centre

Nottingham NG7 2UH, United Kingdom

Hospital R&D contact (matched)

Alison Lloyd

nuhnt.researchsponsor@nhs.net0115 9249924

Oxford University Hospitals NHS Foundation Trust

Oxford OX3 9DU, United Kingdom

Hospital R&D contact (matched)

Shahista Hussain

ouhtma@ouh.nhs.uk---

Western General Hospital

Edinburgh EH4 2XU, United Kingdom

Hospital R&D contact (matched)

Dr Donna Noonan

gwh.researchmanagement@nhs.net01793 605565

Northern Care Alliance NHS Foundation Trust, Greater Manchester

Crumpsall M8 5RB, United Kingdom

Hospital R&D contact (matched)

Katie Doyle

RDResearch@nca.nhs.uk---

Tunbridge Wells Hospital

Kent TN2 4QJ, United Kingdom

Hospital R&D contact (matched)

Denise Day / Julie Knowles

mtw-tr.researchgovernance@nhs.net01622 225627

Barts Health NHS Trust, The Royal London Hospital

London E1 1BB, United Kingdom

Hospital R&D contact (matched)

Dr Mays Jawad

research.governance@qmul.ac.uk020 7882 6826

St. Mark's Hospital

London HA1 3UJ, United Kingdom

University College London Hospital

London NW1 2PG, United Kingdom

Hospital R&D contact (matched)

Rajinder Sidhu - Associate Director, Research Governance and Operations

uclh.jro-communications@nhs.net020 3447 9825

St Thomas' Hospital - Guy's & St Thomas' NHS Foundation Trust

London SE1 7EH, United Kingdom

Hospital R&D contact (matched)

Main Email: gstt.RandD@nhs.net

gstt.RandD@nhs.net---

Kings College Hospital

London SE59RS, United Kingdom

Hospital R&D contact (matched)

Jasmine Palmer

kch-tr.research@nhs.net0203 299 1980

St George's Hospital - St George's Healthcare Nhs Trust

London SW17 0QT, United Kingdom

Hospital R&D contact (matched)

Mr Subhir Bedi

researchgovernance@sgul.ac.uk020 8725 4986

Imperial College Healthcare NHS

London W2 1PG, United Kingdom

Hospital R&D contact (matched)

Donna Copeland

donna.copeland@nhs.net---

Royal Gwent Hospital

Newport NP20 2UB, United Kingdom

Southampton University Hospitals NHS Trust

Southampton SO16 6YD, United Kingdom

Hospital R&D contact (matched)

Dr Mikayala King

researchmanagement@uhs.nhs.uk023 81208215
Data sourced from ClinicalTrials.gov · Last verified: 2026-10