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

Recruiting

• Conditions: Colitis, Ulcerative
• Interventions: Drug: Etrasimod

• Registration Number: NCT06294925
• Lead Sponsor: Pfizer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-28
• Study First Submitted QC: 2024-03-05
• Study First Posted: 2024-03-06
• Study Start: 2024-05-08
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-17
• Last Update Posted: 2025-06-22
• Primary Completion: 2027-04-01
• Study Completion: 2027-05-13

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 360

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:
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  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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients receiving etrasimod for ulcerative colitis	Etrasimod	-

Primary Outcome Measures

Name	Time	Method
Proportion of patients with symptomatic remission	Week 52	Symptomatic remission was defined as stool frequency sub score (SFS)= 0 (or = 1 with a ≥ 1-point decrease from baseline) and rectal bleeding sub score (RBS) =0.. Stool frequency score and rectal bleeding score are components of the Patient-Reported Outcome-2 score derived based on components of Mayo score (PRO2): instrument designed to measure disease activity of ulcerative colitis. Total score range: stool frequency 0 to 3 and rectal bleeding 0 to 3; higher score=more severe disease.

Secondary Outcome Measures

Name	Time	Method
Proportion of patients with clinical response	Week 12	Clinical response was defined as decrease of at least 20% in Patient-Reported Outcome-2 score derived based on components of Mayo score (PRO2) from baseline or achievement of symptomatic remission.
Proportion of patients with clinical response.	Week 52	Clinical response was defined as decrease of at least 20% in Patient-Reported Outcome-2 score derived based on components of Mayo score (PRO2) from baseline or achievement of symptomatic remission.
Proportion of corticosteroid-free patients with symptomatic remission	Week 52	Symptomatic remission was defined as stool frequency sub score (SFS)= 0 (or = 1 with a ≥ 1-point decrease from baseline) and rectal bleeding sub score (RBS) =0.. Stool frequency score and rectal bleeding score are components of the Patient-Reported Outcome-2 score derived based on components of Mayo score (PRO2): instrument designed to measure disease activity of ulcerative colitis. Total score range: stool frequency 0 to 3 and rectal bleeding 0 to 3; higher score=more severe disease. Patients have to be corticosteroid-free for at least 12 weeks prior to the visit.

Trial Locations

Locations (31)

Vancouver Coastal Health; 🇨🇦 Vancouver, British Columbia, Canada

Providence Health Care (PHC); 🇨🇦 Vancouver, British Columbia, Canada

MVZ Gastroenterologie Aachen; 🇩🇪 Aachen, Germany

Tunbridge Wells Hospital; 🇬🇧 Kent, United Kingdom

Kings College Hospital; 🇬🇧 London, United Kingdom

Southampton University Hospitals NHS Trust; 🇬🇧 Southampton, United Kingdom

Gastroenterologie OpernstraBe; 🇩🇪 Kassel, Hessen, Germany

Praxis Heil und Müller; 🇩🇪 Andernach, Germany

MVZ für Gastroenterologie am Bayerischen Platz; 🇩🇪 Berlin, Germany

MVZ Dachau; 🇩🇪 Dachau, Germany

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