What side effects are associated with this type of intervention?

Common treatments for Ulcerative Colitis include 5-aminosalicylates (5-ASA), glucocorticoids, immunomodulators, and selective S1P receptor modulators like Etrasimod. 5-ASA agents can cause nausea, headache, fever, rash, pancreatitis, and pneumonitis. Glucocorticoids are associated with long-term side effects such as adrenal suppression, osteoporosis, and increased infection risk. Immunomodulators like azathioprine can lead to lymphopenia, progressive anemia, and liver enzyme elevation. Selective S1P receptor modulators may cause bradycardia, liver enzyme elevation, and increased risk of infections.

What prior FDA approvals exist?

The FDA has approved several treatments for Ulcerative Colitis, including biologics and small molecules. Notably, Ozanimod, another Selective Sphingosine 1-Phosphate (S1P) Receptor Modulator, has been approved for the treatment of moderately to severely active Ulcerative Colitis. Other approved treatments include anti-TNF agents like Infliximab and Adalimumab, integrin receptor antagonists like Vedolizumab, and Janus kinase inhibitors like Tofacitinib. These treatments aim to reduce inflammation and maintain remission in patients with Ulcerative Colitis.

What other types of research exist?

Promising novel alternatives to Etrasimod for Ulcerative Colitis patients include: 1) Ustekinumab, a monoclonal antibody targeting interleukin-12 and interleukin-23, which has shown efficacy in various immune-mediated disorders. 2) Vedolizumab, an antibody to the alpha4beta7 integrin, effective as induction and maintenance therapy for UC. 3) Risankizumab, targeting interleukin-23, which has demonstrated positive results in phase 3 trials for Crohn's disease and may be applicable to UC. These alternatives offer different mechanisms of action and have shown promising results in clinical studies.

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Sphingosine 1-phosphate receptor modulator

Etrasimod for Ulcerative Colitis

Phase 2

Recruiting

Research Sponsored by Arena Pharmaceuticals

Eligibility Criteria Checklist

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

Must have

Have a diagnosis of ulcerative colitis (UC) that is moderately to severely active

Be younger than 18 years old

Must not have

Diagnosis of microscopic colitis, ischemic colitis, or infectious colitis

Severe extensive colitis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to week 52

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing etrasimod, a medication aimed at treating severe ulcerative colitis in adolescents aged 12 to 17. The drug works by calming the immune system to reduce inflammation in the colon. Participants will be treated for up to a year, with an option to continue for several more years. Etrasimod is an oral medication designed to help with inflammatory conditions.

Who is the study for?

This trial is for adolescents aged 12 to under 18 with moderately to severely active ulcerative colitis. They can still join if they're on certain other UC treatments, but not if they have Crohn's disease, different types of colitis, or a history of severe extensive colitis.

What is being tested?

The study tests Etrasimod's safety and effectiveness in treating ulcerative colitis over a period of one year, with an option to continue up to five years depending on the drug's approval status in the participant’s country.

What are the potential side effects?

While specific side effects are not listed here, participants will be monitored for any adverse reactions due to Etrasimod throughout the study and long-term extension phase.

Eligibility Criteria

Inclusion Criteria

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

Select...

My ulcerative colitis is moderate to severe.

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.

Select...

I have severe widespread inflammation in my colon.

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to week 52

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to week 52

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 52 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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: EtrasimodExperimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Etrasimod

2020

Completed Phase 3

~1580

0 / 4Eligibility 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

Selective Sphingosine 1-Phosphate (S1P) Receptor Modulators, such as Etrasimod, work by modulating the S1P receptor, which plays a crucial role in lymphocyte trafficking. By preventing lymphocytes from exiting lymph nodes, these drugs reduce the number of inflammatory cells reaching the gut, thereby decreasing inflammation. This mechanism is particularly important for UC patients as it directly targets the immune response that drives the disease. Other common treatments include anti-TNF agents, which block tumor necrosis factor, a key inflammatory cytokine; corticosteroids, which broadly suppress inflammation; and thiopurines, which inhibit DNA synthesis in immune cells, reducing their proliferation. Each of these treatments aims to control the excessive immune response characteristic of UC, thereby reducing symptoms and promoting remission.