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Sphingosine-1-Phosphate Receptor Modulator

Etrasimod for Ulcerative Colitis (ELEVATE UC OLE Trial)

Phase 3
Waitlist Available
Research Sponsored by Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 8 years
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial will assess the safety and efficacy of etrasimod in people with moderate-to-severe UC who have previously received treatment in a double-blind study.

Who is the study for?
This trial is for people with moderate to severe ulcerative colitis who were in previous phase 2 or 3 trials of etrasimod. They must have finished at least 12 weeks of the prior study and still have active symptoms, or their condition must not have improved or worsened.
What is being tested?
The trial tests the long-term safety and effectiveness of etrasimod, a medication for ulcerative colitis. Participants will receive etrasimod openly, meaning they'll know they're getting the actual drug, not a placebo.
What are the potential side effects?
Etrasimod may cause side effects such as headaches, nausea, respiratory infections, high blood pressure, and potential liver issues. The exact side effects can vary from person to person.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 8 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 8 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number and Severity of Safety Measures
Secondary study objectives
Change From Baseline in Partial Mayo Score
Change From Baseline in the Total Mayo Score

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.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Etrasimod 2 mgExperimental 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?

Arena is a wholly owned subsidiary of PfizerIndustry Sponsor
10 Previous Clinical Trials
1,793 Total Patients Enrolled
4 Trials studying Colitis
366 Patients Enrolled for Colitis
PfizerLead Sponsor
4,675 Previous Clinical Trials
28,716,403 Total Patients Enrolled
40 Trials studying Colitis
9,653 Patients Enrolled for Colitis
Arena PharmaceuticalsLead Sponsor
28 Previous Clinical Trials
5,024 Total Patients Enrolled
8 Trials studying Colitis
1,427 Patients Enrolled for Colitis
Arena CT.gov AdministratorStudy DirectorArena Pharmaceuticals
21 Previous Clinical Trials
4,030 Total Patients Enrolled
8 Trials studying Colitis
1,427 Patients Enrolled for Colitis
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,556 Previous Clinical Trials
25,757,259 Total Patients Enrolled
32 Trials studying Colitis
9,104 Patients Enrolled for Colitis

Media Library

Etrasimod (Sphingosine-1-Phosphate Receptor Modulator) Clinical Trial Eligibility Overview. Trial Name: NCT03950232 — Phase 3
Colitis Research Study Groups: Etrasimod 2 mg
Colitis Clinical Trial 2023: Etrasimod Highlights & Side Effects. Trial Name: NCT03950232 — Phase 3
Etrasimod (Sphingosine-1-Phosphate Receptor Modulator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03950232 — Phase 3
~352 spots leftby Jun 2029
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