Etrasimod for Ulcerative Colitis

Recruiting in Palo Alto (17 mi)

+62 other locations

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Arena Pharmaceuticals

Disqualifiers: Severe colitis, Crohn's, others

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial allows participants to continue taking certain ulcerative colitis medications, so you may not need to stop your current meds. However, it depends on which specific medications you are taking.

What data supports the effectiveness of the drug Etrasimod for treating ulcerative colitis?

Research shows that Etrasimod, a drug taken orally, helped more patients with moderate to severe ulcerative colitis achieve remission (a period without symptoms) compared to those who took a placebo (a pill with no active drug) over 12 and 52 weeks. It was generally well tolerated, although some patients experienced more side effects.

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Is Etrasimod safe for humans?

Etrasimod has been generally well tolerated in clinical trials for ulcerative colitis, with studies showing it was safe for up to 52 weeks, although some participants experienced more adverse events (unwanted side effects) compared to those taking a placebo (a harmless pill used for comparison).

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How is the drug etrasimod different from other treatments for ulcerative colitis?

Etrasimod is unique because it is an oral medication that selectively targets specific sphingosine 1-phosphate receptors, which helps prevent immune cells from moving into the bloodstream and causing inflammation. This mechanism offers a new approach compared to other treatments for ulcerative colitis.

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Eligibility Criteria

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.

Inclusion Criteria

My ulcerative colitis is moderate to severe.

I am currently taking medication for ulcerative colitis.

Exclusion Criteria

I have been diagnosed with a specific type of colitis.

I have severe widespread inflammation in my colon.

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

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive etrasimod for the treatment of moderately to severely active ulcerative colitis

52 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Long-Term Extension

Participants may continue treatment in a Long-Term Extension period of up to 4 years

Up to 4 years

Participant Groups

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.

Group I: Etrasimod Experimental Treatment 1 Intervention

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Boston Children's Hospital Boston, MA

University Hospitals Cleveland Medical Center Rainbow Babies & Children's Hospital Cleveland, OH

Beaumont Hospital Royal Oak, MI

DCT - Midwest GI Abilene, TX

More Trial Locations

Who Is Running the Clinical Trial?

Arena Pharmaceuticals Lead Sponsor

Pfizer Lead Sponsor

Arena is a wholly owned subsidiary of Pfizer Collaborator

Arena is a wholly owned subsidiary of Pfizer Industry Sponsor

References

1. United States pubmed.ncbi.nlm.nih.gov

In moderately to severely active UC, etrasimod increased remission at 12 and 52 wk but increased adverse events. [2023] Label="SOURCE CITATION">Sandborn WJ, Vermeire S, Peyrin-Biroulet L, et al. Etrasimod as induction and maintenance therapy for ulcerative colitis (ELEVATE): two randomised, double-blind, placebo-controlled, phase 3 studies. Lancet. 2023;401:1159-1171. 36871574.

2. England pubmed.ncbi.nlm.nih.gov

Long-term Safety and Efficacy of Etrasimod for Ulcerative Colitis: Results from the Open-label Extension of the OASIS Study. [2021] Etrasimod is an oral, selective, sphingosine 1-phosphate receptor modulator. In a phase 2, randomised, double-blind, placebo-controlled trial in adults with moderately-to-severely active ulcerative colitis [OASIS], etrasimod 2 mg provided significant benefit versus placebo and was generally well tolerated. This open-label extension [OLE] evaluated safety and efficacy of etrasimod for up to 52 weeks.

3. United States pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Etrasimod in a Phase 2 Randomized Trial of Patients With Ulcerative Colitis. [2020] Etrasimod (APD334) is an oral, selective sphingosine 1-phosphate receptor modulator in development for immune-mediated inflammatory disorders. We assessed the efficacy and safety of etrasimod in patients with moderately to severely active ulcerative colitis (UC).

4. England pubmed.ncbi.nlm.nih.gov

Etrasimod for the treatment of ulcerative colitis. [2023] Sphingosine-1-phosphate (S1P) and its receptor (S1PR) are involved in the pathogenesis of multiple immune-mediated inflammatory disorders, including inflammatory bowel disease. The use of S1PR modulators represents a new therapeutic option for ulcerative colitis patients. Etrasimod is an oral selective S1PR1, S1PR4 and S1PR5 modulator that inhibits the trafficking of lymphocytes from the lymph nodes into the blood. Recently, etrasimod has demonstrated efficacy in the phase II OASIS study and its open-label extension for the treatment of ulcerative colitis patients. This article reviews the mechanism of action of etrasimod and summarizes the available clinical efficacy and safety data regarding etrasimod, which is a promising drug in the treatment of patients with moderate to severe ulcerative colitis.

5. England pubmed.ncbi.nlm.nih.gov

Etrasimod as induction and maintenance therapy for ulcerative colitis (ELEVATE): two randomised, double-blind, placebo-controlled, phase 3 studies. [2023] Label="BACKGROUND">Etrasimod, a once-daily, oral, sphingosine 1-phosphate (S1P) receptor modulator that selectively activates S1P receptor subtypes 1, 4, and 5, with no detectable activity on S1P2,3, is in development for the treatment of immune-mediated diseases, including ulcerative colitis. In these two phase 3 trials, we aimed to evaluate the safety and efficacy of etrasimod in adult patients with moderately to severely active ulcerative colitis.