Recruiting at 39 sites Phase 2 Ulcerative Colitis

Ulcerative Colitis study: Etrasimod

Official title A Study to Evaluate Etrasimod Treatment in Adolescents With Ulcerative Colitis

ClinicalTrials.gov ID: NCT05287126

What this study is testing

What is Etrasimod?

An investigational oral tablet or granule being studied as a potential treatment for moderately to severely active ulcerative colitis in adolescents. It is designed to modulate sphingosine‑1‑phosphate receptors, which may affect immune cell movement.

Also referred to as APD334.

Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
This study aims to find out if etrasimod is safe and effective for treating active ulcerative colitis in teenagers. It also measures how the body processes the medication.
Who it's for
The study is looking for teenagers aged 12 to 17 who have moderate to severe ulcerative colitis.
What's involved
Participants will take etrasimod and undergo medical tests to check for side effects and how well the treatment works.
Time commitment
The main study lasts 52 weeks, with an option to stay in a long-term follow-up period for up to 4 more years.
  • Phase 2: a mid-size study of how well it works

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 12 to 17

You may be able to join if

  • Have a diagnosis of ulcerative colitis (UC) that is moderately to severely active
  • Participants are permitted to be receiving a therapeutic dose of select UC therapies

You likely can't join if

  • Severe extensive colitis
  • Diagnosis of Crohn's disease (CD) or indeterminate colitis or the presence or history of a fistula consistent with CD
  • Diagnosis of microscopic colitis, ischemic colitis, or infectious colitis

The study team makes the final eligibility decision.

Where it is enrolling

  • Garden Grove, California, United States
  • San Francisco, California, United States
  • Orlando, Florida, United States
  • Chicago, Illinois, United States
  • Boston, Massachusetts, United States
  • Royal Oak, Michigan, United States
  • Cleveland, Ohio, United States
  • Abilene, Texas, United States
  • Fort Worth, Texas, United States
  • Kashiwa, Chiba, Japan
  • Nagareyama-shi, Chiba, Japan
  • Maebashi, Gunma, Japan
  • Nishinomiya, Hyōgo, Japan
  • Ikoma, Nara, Japan
  • Saitama-shi, Saitama, Japan
  • Shimotsuke, Tochigi, Japan
  • Bunkyo-ku, Tokyo, Japan
  • Kyoto, Japan
  • Saga, Japan
  • Toyama, Japan

+ 12 more site(s).

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 12 years to 17 years. The study team makes the final eligibility decision.

Where is this trial taking place?

This study is enrolling now at Garden Grove, California, United States; San Francisco, California, United States; Orlando, Florida, United States; Chicago, Illinois, United States; Boston, Massachusetts, United States; Royal Oak, Michigan, United States and 26 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.