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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up pre-dose and 4 hours (±15 minutes) post-dose at day 1; at trough concentrations (approximately 24 hours after the dose taken the day before the study visit) at weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52

Awards & highlights

Study Summary

This trial will test the safety and effectiveness of a new drug, etrasimod, for treating ulcerative colitis in adolescents. If it is successful, participants will be able to take the drug for up to 5 years.

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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre-dose and 4 hours (±15 minutes) post-dose at day 1; at trough concentrations (approximately 24 hours after the dose taken the day before the study visit) at weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pre-dose and 4 hours (±15 minutes) post-dose at day 1; at trough concentrations (approximately 24 hours after the dose taken the day before the study visit) at weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52

This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-dose and 4 hours (±15 minutes) post-dose at day 1; at trough concentrations (approximately 24 hours after the dose taken the day before the study visit) at weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Proportion of Participants Achieving Clinical Remission as Assessed by Modified Mayo Score (MMS) at Week 52

Secondary outcome measures

Number and Severity of Adverse Events

Plasma Concentration of Etrasimod at 4 Hours Post-dose (C4h)

Plasma Steady State Trough Concentration (Ctrough,ss) of Etrasimod

+13 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

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

~1350

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Arena is a wholly owned subsidiary of PfizerUNKNOWN

10 Previous Clinical Trials

2,609 Total Patients Enrolled

4 Trials studying Ulcerative Colitis

1,242 Patients Enrolled for Ulcerative Colitis

Arena PharmaceuticalsLead Sponsor

28 Previous Clinical Trials

5,840 Total Patients Enrolled

8 Trials studying Ulcerative Colitis

2,303 Patients Enrolled for Ulcerative Colitis

PfizerLead Sponsor

4,568 Previous Clinical Trials

10,911,850 Total Patients Enrolled

32 Trials studying Ulcerative Colitis

425,983 Patients Enrolled for Ulcerative Colitis

Media Library

Etrasimod (Sphingosine 1-phosphate receptor modulator) Clinical Trial Eligibility Overview. Trial Name: NCT05287126 — Phase 2

Ulcerative Colitis Research Study Groups: Etrasimod

Ulcerative Colitis Clinical Trial 2023: Etrasimod Highlights & Side Effects. Trial Name: NCT05287126 — Phase 2

Etrasimod (Sphingosine 1-phosphate receptor modulator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05287126 — 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 will be given the chance to participate in this experiment?

"Yes, the clinical trial is currently recruiting participants. The trial was originally posted on 11/1/2022 and was last edited on 10/21/2022. The clinical trial is looking for 36 participants at 1 site."

Answered by AI

When will Etrasimod be available for public use?

"Etrasimod is a medication that, while having shown some promise in terms of safety, has not yet been proven effective. As such, it received a score of 2."

Answered by AI

How can I sign up to participate in this research?

"This clinical trial is only open to those that have ulcers and are between the ages of 12-17. Out of the total 36 participants, how many will be chosen is yet to be decided."

Answered by AI

Does this experimental treatment have an age limit?

"According to the inclusion criteria, applicants that are aged 12 to 17 qualify for this trial. Out of 434 active trials, 71 are specifically for minors and 363 are catered to adults over 65 years old."

Answered by AI

Are we currently accepting people into this research program?

"That is correct, the information available on clinicaltrials.gov says that this trial is looking for subjects at the moment. This trial was initially posted on November 1st, 2020 and was edited most recently on October 21st, 2020. The study will have 36 participants between 1 site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Evaluate Etrasimod Treatment in Adolescents With Ulcerative Colitis

2022. "A Study to Evaluate Etrasimod Treatment in Adolescents With Ulcerative Colitis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05287126.

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