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New treatment option for Ulcerative Colitis
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?
Etrasimod is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for ulcerative colitis.
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
- The purpose of this study is to determine the safety, efficacy, and pharmacokinetics (PK) of etrasimod for the treatment of moderately to severely active ulcerative colitis in adolescents (≥ 12 years up to \< 18 years of age). Participants who will complete the total 52-week treatment period will have the opportunity to continue in a Long-Term Extension (LTE) Period of up to 4 years (5 years after study enrollment).
- 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's taking place
- Little Rock, Arkansas, United States
- Garden Grove, California, United States
- Loma Linda, California, United States
- San Bernardino, 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
- 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
+ 14 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 - 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?
Study sites include Little Rock, Arkansas, United States; Garden Grove, California, United States; Loma Linda, California, United States; San Bernardino, California, United States; San Francisco, California, United States; Orlando, Florida, United States and 28 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.