An Observational Study of Etrasimod in Adult Patients With Moderate to Severe Ulcerative Colitis

Recruiting

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

• Registration Number: NCT06398626
• Lead Sponsor: Pfizer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-04-30
• Study First Submitted QC: 2024-04-30
• Study First Posted: 2024-05-03
• Study Start: 2024-09-17
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-18
• Last Update Posted: 2024-11-20
• Primary Completion: 2027-05-04
• Study Completion: 2027-09-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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 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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Adult patients with ulcerative colitis taking etrasimod	Etrasimod	-

Primary Outcome Measures

Name	Time	Method
Proportion of patients with symptomatic remission	Week 12	Symptomatic remission is defined as partial Modified Mayo Score (pMMS) stool frequency subscore (SFS) = 0 (or = 1 with a ≥ 1-point decrease from baseline) and (RBS) rectal bleeding subscore = 0

Secondary Outcome Measures

Name	Time	Method
Proportion of patients with symptomatic remission	Weeks 24, 36, 52	Symptomatic remission is defined as partial Modified Mayo Score (pMMS) stool frequency subscore (SFS) = 0 (or = 1 with a ≥ 1-point decrease from baseline) and (RBS) rectal bleeding subscore = 0
Proportion of patients with symptomatic response	Weeks 12, 24, 36, 52	Symptomatic response defined as a decrease from baseline ≥ 20% in pMMS composite RBS and SFS
Proportion of patients with clinical remission	Weeks 12, 24, 36, 52	Clinical remission is defined as a pMMS ≤ 2 points, with no individual subscores \> 1 point.
Proportion of patients with steroid-free symptomatic remission	Weeks 24, 36, 52	Steroid-free symptomatic remission is defined as patients in symptomatic remission who did not take any corticosteroid treatment for 8 weeks prior to the visit/timepoint
Proportion of patients with steroid-free clinical remission	Weeks 24, 36, 52	Steroid-free clinical remission is defined as patients in clinical remission (using a pMMS) who did not take any corticosteroid treatment for 8 weeks prior to the visit/timepoint
Change from baseline in fatigue	Weeks 12, 24, 36, 52	Change from baseline in the Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue score; Normalization of fatigue is defined as a FACIT Fatigue score ≥ 40.1
Change from baseline of bowel urgency	Weeks 12, 24, 36, 52	Change from baseline in bowel urgency on a 0 (no urgency) - 10 (worst possible urgency) numeric rating scale
Proportion of patients with a clinically meaningful improvement in bowel urgency	Weeks 12, 24, 36, 52	Clinically meaningful improvement in bowel urgency is defined as ≥ 3-point decrease from baseline among patients with baseline bowel urgency score ≥ 3
Proportion of patients in bowel urgency remission	Weeks 12, 24, 36, 52	Bowel urgency remission is defined as a bowel urgency score ≤ 1 among patients with a baseline bowel urgency score ≥ 3 and the overall population
Proportion of patients with complete bowel urgency remission	Weeks 12, 24, 36, 52	Complete bowel urgency remission is defined as a bowel urgency Numeric Rating Scale score = 0
Change from baseline in abdominal pain	Weeks 12, 24, 36, 52	Change from baseline in abdominal pain on a 0 (no pain) - 10 (pain as bad as can imagine) numeric rating scale
Proportion of patients with abdominal pain remission	Weeks 12, 24, 36, 52	Abdominal pain remission is defined as an abdominal pain Numeric Rating Scale score = 0

Trial Locations

Locations (13)

BI Research Center; 🇺🇸 Houston, Texas, United States

Reddy GI Associates; 🇺🇸 Mesa, Arizona, United States

Amicis Research Center; 🇺🇸 Valencia, California, United States

Rocky Mountain Gastroenterology; 🇺🇸 Littleton, Colorado, United States

Gastro Florida; 🇺🇸 Lutz, Florida, United States

Best Choice Medical Research Service; 🇺🇸 Pembroke Pines, Florida, United States

EBGS Clinical Research Center; 🇺🇸 Snellville, Georgia, United States

MGG Group Co., Inc., Chevy Chase Clinical Research; 🇺🇸 Chevy Chase, Maryland, United States

Woodholme Gastroenterology Associates PA; 🇺🇸 Glen Burnie, Maryland, United States

NYU Langone Health; 🇺🇸 New York, New York, United States

University of North Carolina at Chapel Hill, Division of Gastroenterology and Hepatology; 🇺🇸 Chapel Hill, North Carolina, United States

Hightower Clinical Trial Services; 🇺🇸 Oklahoma City, Oklahoma, United States

Washington Gastroenterology; 🇺🇸 Tacoma, Washington, United States