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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
Moderately active UC defined as a modified Mayo score of 4 to 6 and an endoscopic score ≥ 2 and rectal bleeding score ≥ 1
Be older than 18 years old
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...
My ulcerative colitis is moderately active, with noticeable symptoms and inflammation.

GLADIATOR UC Trial Timeline

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
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

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

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
4,582 Previous Clinical Trials
14,634,563 Total Patients Enrolled
32 Trials studying Ulcerative Colitis
425,800 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
~6 spots leftby Jul 2024
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