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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

ELEVATE UC OLE 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.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.

ELEVATE UC OLE Trial 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

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 more
Other 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 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%
COVID-19
4%
Contusion
4%
Back pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo Comparator: Placebo
Experimental: Etrasimod 2 mg

ELEVATE UC OLE 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
4,567 Previous Clinical Trials
10,907,166 Total Patients Enrolled
32 Trials studying Ulcerative Colitis
425,107 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

Media Library

Etrasimod (Sphingosine-1-Phosphate Receptor Modulator) Clinical Trial Eligibility Overview. Trial Name: NCT03950232 — Phase 3
Ulcerative Colitis Research Study Groups: Etrasimod 2 mg
Ulcerative 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this study only for patients who are 35 years or older?

"Patients that meet the requirements for this study must be between 16 and 80 years old. There are 72 clinical trials for people under 18 and 369 for patients over 65."

Answered by AI

What makes this research project unique compared to others?

"There are currently 7 active clinical trials for Etrasimod in 368 cities and 50 countries. The first trial was conducted in 2019 by Arena Pharmaceuticals. 912 participants were involved and the study completed its Phase 3 drug approval stage. Since then, 6 more trials have been carried out."

Answered by AI

When will Etrasimod be cleared for public use by the FDA?

"Etrasimod has been rated a 3 for safety by our team at Power. This is because there is some data supporting efficacy and multiple rounds of data supporting safety, as this is a Phase 3 trial."

Answered by AI

In how many different places is this trial being conducted?

"Right now, there are 44 different enrolling sites for this study. While some locations are in Ogden, Orange and La Jolla, other enrolment centres are more widespread to allow closer proximity for potential participants. If you do decide to take part in this research project, try to choose the location that is closest to reduce travel burden."

Answered by AI

Who would be an eligible candidate for this research?

"Eligible patients for this study must have a diagnosis of colitis, be between 16-80 years old, and meet one the following criteria: -Have completed the Week 12 visit in Study APD334-301 (NCT03945188) or APD334-210 (NCT04607837), with an assessment of active UC that has not improved or has worsened from baseline. -OR have completed the Week 52 visit in APD334-302 (NCT03996369)."

Answered by AI

How many individuals are taking part in this research project?

"912 patients that pass the screening process are necessary to run this study smoothly. Arena Pharmaceuticals, the trial's sponsor, will be managing different research sites; two examples include Care Access Research LLC in Ogden, Utah and University of California, Irvine in Orange, California."

Answered by AI

Are there precedents for this Etrasimod clinical trial?

"Etrasimod was first studied in 2019 at Fakultni nemocnice u svate Anny v Brne. There have been 6 completed trials since then, with 7 more active clinical trials as of now. Many of these are based in Ogden, Utah."

Answered by AI

Are patients being actively sought for this experiment?

"That is correct, the online information portal clinicaltrials.gov has this trial listed as currently seeking participants. The 912 patients will be drawn from 44 different hospitals, clinics, and medical research institutions."

Answered by AI

Who else is applying?

What state do they live in?
Texas
How old are they?
18 - 65
What site did they apply to?
Texas Digestive Disease Consultants - San Marcos
What portion of applicants met pre-screening criteria?
Did not meet criteria
~300 spots leftby Jul 2026