What side effects are associated with this type of intervention?

Common treatments for Ulcerative Colitis include 5-aminosalicylates (e.g., mesalamine), glucocorticoids (e.g., prednisone), immunomodulators (e.g., azathioprine), and biologic therapies (e.g., infliximab). Side effects of 5-aminosalicylates can include nausea, headache, and rash. Glucocorticoids are associated with weight gain, hypertension, and increased risk of infections. Immunomodulators may cause bone marrow suppression, liver toxicity, and increased risk of infections. Biologic therapies can lead to infusion reactions, infections, and potential development of antibodies against the medication. Etrasimod, as an S1P receptor modulator, may have side effects such as bradycardia, liver enzyme elevations, and infections.

What prior FDA approvals exist?

The FDA has approved several treatments for Ulcerative Colitis, including 5-aminosalicylic acid (5-ASA) agents like mesalamine and sulfasalazine, which are commonly used for mild to moderate cases. For more severe cases, biologics such as anti-TNF agents (e.g., infliximab, adalimumab) and integrin receptor antagonists (e.g., vedolizumab) have been approved. Recently, the FDA has also approved other S1P receptor modulators like ozanimod for the treatment of Ulcerative Colitis, which is similar to the investigational drug Etrasimod being studied for its safety and efficacy in treating moderately active Ulcerative Colitis.

What other types of research exist?

Promising novel alternatives to Etrasimod for Ulcerative Colitis patients include Ustekinumab, a monoclonal antibody targeting interleukin-12 and interleukin-23, and Vedolizumab, an integrin receptor antagonist. Both have shown efficacy in treating UC and are considered effective options for patients seeking new treatments.

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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

Must not have

Diagnosis of microscopic colitis, ischemic colitis, or infectious colitis

Diagnosis of Crohn's disease or indeterminate colitis or the presence or history of a fistula consistent with Crohn's disease

Timeline

Screening 3 weeks

Treatment Varies

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

Summary

This trial is testing whether a medication called etrasimod, taken by mouth, is safe and effective for adults with moderately active ulcerative colitis. Ulcerative colitis is a condition where the colon becomes inflamed. Etrasimod works by helping to reduce this inflammation through its effects on the immune system.

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

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

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have been diagnosed with a specific type of colitis.

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I have been diagnosed with Crohn's disease or have a history of fistulas related to it.

Select...

I was hospitalized for a severe UC flare-up and received IV steroids within the last 12 weeks.

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I have severe widespread inflammation in my colon.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Number and Severity of Adverse Events

Side effects data

From 2022 Phase 3 trial • 42 Patients • NCT04706793

14%

Headache

11%

Malaise

11%

Pyrexia

Colitis ulcerative

Vaccination site pain

Back pain

COVID-19

Contusion

100%

80%

60%

40%

20%

Study treatment Arm

Placebo Comparator: Placebo

Experimental: Etrasimod 2 mg

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

~1580

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Ulcerative Colitis (UC) include 5-aminosalicylates (5-ASA), glucocorticoids, immunomodulators, and biologics. 5-ASA agents, such as mesalamine, work by reducing inflammation directly in the colon. Glucocorticoids, like prednisone, suppress the overall immune response to decrease inflammation but are not suitable for long-term use due to side effects. Immunomodulators, such as azathioprine, alter the immune system to prevent ongoing inflammation. Biologics, including anti-TNF agents like infliximab, target specific components of the immune system to reduce inflammation. Etrasimod, an S1P receptor modulator, works by preventing lymphocytes from exiting lymph nodes, thereby reducing their presence in the colon and decreasing inflammation. Understanding these mechanisms helps UC patients and their doctors choose the most effective treatment tailored to their specific condition and response to therapy.