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Sphingosine 1-phosphate receptor modulator

Etrasimod for Ulcerative Colitis (GLADIATOR UC Trial)

Phase 2

Waitlist Available

Research Sponsored by Arena Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosed with Ulcerative Colitis (UC) ≥ 3 months prior to screening

Moderately active UC defined as a modified Mayo score of 4 to 6 and an endoscopic score ≥ 2 and rectal bleeding score ≥ 1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 56 weeks (52-week treatment period and 4-week follow-up period)

Awards & highlights

GLADIATOR UC Trial Summary

This trial will test whether the drug etrasimod is safe and effective for treating ulcerative colitis.

Who is the study for?

Adults with moderately active ulcerative colitis, confirmed by recent endoscopy, can join this trial. They should have a history of UC for at least 3 months and not be hospitalized for severe UC recently. People with other types of colitis or Crohn's disease cannot participate.Check my eligibility

What is being tested?

The study is testing if etrasimod, taken orally, helps adults with moderate ulcerative colitis compared to a placebo (a pill without the drug). Participants won't know which one they're getting as it's chosen randomly.See study design

What are the potential side effects?

Etrasimod may cause side effects like headaches, nausea, respiratory infections and high blood pressure. Since it affects the immune system, there might also be an increased risk of infections.

GLADIATOR UC Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I was diagnosed with Ulcerative Colitis more than 3 months ago.

Select...

My ulcerative colitis is moderately active, with noticeable symptoms and inflammation.

GLADIATOR UC Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 56 weeks (52-week treatment period and 4-week follow-up period)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 56 weeks (52-week treatment period and 4-week follow-up period)

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 56 weeks (52-week treatment period and 4-week follow-up period) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Secondary outcome measures

Number and Severity of Adverse Events

Proportion of Participants Achieving Clinical Remission

Proportion of Participants Achieving Endoscopic Improvement

+4 more

Side effects data

From 2022 Phase 3 trial • 42 Patients • NCT04706793

14%

Headache

11%

Malaise

11%

Pyrexia

Colitis ulcerative

Vaccination site pain

COVID-19

Contusion

Back pain

100%

80%

60%

40%

20%

Study treatment Arm

Placebo Comparator: Placebo

Experimental: Etrasimod 2 mg

GLADIATOR UC Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Etrasimod 2 mgExperimental Treatment1 Intervention

Group II: PlaceboPlacebo Group1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Etrasimod

2020

Completed Phase 3

~1350

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Arena is a wholly owned subsidiary of PfizerIndustry Sponsor

10 Previous Clinical Trials

2,411 Total Patients Enrolled

4 Trials studying Ulcerative Colitis

1,044 Patients Enrolled for Ulcerative Colitis

Arena PharmaceuticalsLead Sponsor

28 Previous Clinical Trials

5,642 Total Patients Enrolled

8 Trials studying Ulcerative Colitis

2,105 Patients Enrolled for Ulcerative Colitis

PfizerLead Sponsor

4,567 Previous Clinical Trials

10,911,639 Total Patients Enrolled

32 Trials studying Ulcerative Colitis

425,785 Patients Enrolled for Ulcerative Colitis

Media Library

Etrasimod (Sphingosine 1-phosphate receptor modulator) Clinical Trial Eligibility Overview. Trial Name: NCT04607837 — Phase 2

Ulcerative Colitis Research Study Groups: Placebo, Etrasimod 2 mg

Ulcerative Colitis Clinical Trial 2023: Etrasimod Highlights & Side Effects. Trial Name: NCT04607837 — Phase 2

Etrasimod (Sphingosine 1-phosphate receptor modulator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04607837 — Phase 2

Frequently Asked Questions

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

How many people can join this trial at most?

"To carry out this clinical trial, 225 patients that meet the necessary inclusion criteria are required. The sponsor, Arena Pharmaceuticals, will be managing the study from multiple locations including West Central Gastroenterology d/b/a Gastro Florida in Clearwater, Florida and University of California, Irvine in Orange, California."

Answered by AI

Might I be eligible to enroll in this research?

"Up to 225 patients with colitis will be enrolled in this trial, so long as they are between 18-80 years old. Most importantly, potential candidates must have had a colonoscopy confirming their UC diagnosis within the last year and a moderate level of activity, as defined by the Mayo score."

Answered by AI

Does this research study have an age limit?

"This clinical trial is for people aged 18-80. If you are outside of this age range, there may be other trials more suitable for you; 72 trials focus on those under 18 while 370 study adults over 65 years old."

Answered by AI

Are there any other published papers on Etrasimod's effectiveness?

"Etrasimod is being trialled in 7 studies, 3 of which are Phase 3. The majority of Etrasimod's clinical trials are located in Región, Gyeonggi-do, but there are 1,129 total research sites."

Answered by AI

At how many total sites is this clinical trial being carried out?

"This clinical trial is currently active at 48 different sites. The locations are spread out across Clearwater, Orange, Calgary and 48 other cities. If you are considering participating in the trial, it might be helpful to choose a location that is nearest to you in order to minimize travel demands."

Answered by AI

Are people with the relevant medical conditions currently being accepted into this research program?

"The clinicaltrials.gov website indicates that this research is currently looking for participants. This study was originally posted on April 19th, 2021 and has been edited as recently as October 13th, 2022."

Answered by AI

Is this medical study novel in any way?

"Etrasimod has undergone clinical trials since 2019. Arena Pharmaceuticals sponsored the first study which concluded that year and featured 912 participants. Etrasimod received Phase 3 approval after this initial trial. As of now, there are 7 active etrasimod trials taking place in 368 cities and 50 countries worldwide."

Answered by AI

Could you please explain the risks associated with Etrasimod?

"While Phase 2 trials offer some data to support a medication's safety, there is no evidence of efficacy. Therefore, our team at Power has rated Etrasimod as a 2 on our safety scale."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Etrasimod Versus Placebo for the Treatment of Moderately Active Ulcerative Colitis

2021. "Etrasimod Versus Placebo for the Treatment of Moderately Active Ulcerative Colitis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04607837.

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