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Adult patients with ulcerative colitis taking etrasimod for Ulcerative Colitis (ENDEAVOUR-UC Trial)

N/A
Recruiting
Research Sponsored by Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 12, 24, 36, 52
Awards & highlights
No Placebo-Only Group

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.

Eligible Conditions
  • Ulcerative Colitis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 12, 24, 36, 52
This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 12, 24, 36, 52 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Change from baseline in abdominal pain
Change from baseline in fatigue
Change from baseline of bowel urgency
+9 more

Side effects data

From 2022 Phase 3 trial • 42 Patients • NCT04706793
14%
Headache
11%
Malaise
11%
Pyrexia
7%
Colitis ulcerative
7%
Vaccination site pain
4%
Back pain
4%
COVID-19
4%
Contusion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo Comparator: Placebo
Experimental: Etrasimod 2 mg

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Adult patients with ulcerative colitis taking etrasimodExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Etrasimod
2020
Completed Phase 3
~1580

Find a Location

Who is running the clinical trial?

PfizerLead Sponsor
4,647 Previous Clinical Trials
17,743,355 Total Patients Enrolled
33 Trials studying Ulcerative Colitis
425,934 Patients Enrolled for Ulcerative Colitis
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,534 Previous Clinical Trials
14,914,651 Total Patients Enrolled
26 Trials studying Ulcerative Colitis
11,751 Patients Enrolled for Ulcerative Colitis
~200 spots leftby May 2027