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Sphingosine-1-Phosphate Receptor Modulator
Etrasimod for Ulcerative Colitis (ELEVATE UC OLE Trial)
Phase 3
Recruiting
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
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.Check my eligibility
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.See study design
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 8 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 8 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number and Severity of Safety Measures
Secondary outcome measures
Change From Baseline in Partial Mayo Score
Change From Baseline in the Total Mayo Score
Proportion of Participants Achieving Clinical Remission Assessed by Mayo Component Sub-scores
+3 moreOther outcome measures
Percentage of Participants With Histologic Improvement Assessed by the Geboes, Robarts, and Nancy Histopathology Scores
Percentage of Participants With Histologic Remission Assessed by the Geboes, Robarts, and Nancy Histopathology Scores
Proportion of Participants Achieving Improvement in Extraintestinal Manifestations (EIMs) in Participants With EIMs at Baseline
+1 moreSide effects data
From 2022 Phase 3 trial • 42 Patients • NCT0470679314%
Headache
11%
Malaise
11%
Pyrexia
7%
Colitis ulcerative
7%
Vaccination site pain
4%
COVID-19
4%
Contusion
4%
Back pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo Comparator: Placebo
Experimental: Etrasimod 2 mg
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
~1350
Find a Location
Who is running the clinical trial?
Arena is a wholly owned subsidiary of PfizerIndustry Sponsor
10 Previous Clinical Trials
1,733 Total Patients Enrolled
4 Trials studying Ulcerative Colitis
366 Patients Enrolled for Ulcerative Colitis
PfizerLead Sponsor
4,595 Previous Clinical Trials
12,867,858 Total Patients Enrolled
33 Trials studying Ulcerative Colitis
425,226 Patients Enrolled for Ulcerative Colitis
Arena PharmaceuticalsLead Sponsor
28 Previous Clinical Trials
4,964 Total Patients Enrolled
8 Trials studying Ulcerative Colitis
1,427 Patients Enrolled for Ulcerative Colitis
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Eligibility Criteria:
This trial includes the following eligibility criteria:- People who were previously enrolled in the study called APD334-302 must have finished their visit at Week 12.I was in a previous study and either my UC didn't improve by Week 12 or I completed Week 52.
Research Study Groups:
This trial has the following groups:- Group 1: Etrasimod 2 mg
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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