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A Study of how the Medicine Called "Etrasimod" Works in Children With the gut Disease Called Ulcerative Colitis
EU CTIS ID: 2025-523100-77-00
What this study is testing
To assess the efficacy of etrasimod on clinical remission in pediatric participants (≥2 years to <12 years of age) with moderately to severely active UC after 52 weeks of treatment
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Children ≥2 years to <12 years of age at the time of enrollment (Week 0/Day 1), who were diagnosed ≥4 weeks prior to screening with histologically and endoscopically confirmed active UC extending proximal to the rectum.
- 2. Participants must have moderately to severely active UC, defined as MMS of 5 to 9, including an ES ≥2 and RB subscore ≥1 prior to baseline (Day 1).
- 3. Participants must have demonstrated an inadequate response to, loss of response to, or intolerance to at least one of the conventional or biologic/Janus Kinase (JAK) inhibitor therapies.
You likely can't join if
- 1. Participants with any other type of inflammatory bowel disease (IBD) than UC cannot enroll.
- 2. Previous use of >2 advanced treatments (biologic or JAK inhibitors) is not allowed.
- 3. Present severe extensive UC, recent UC exacerbation that required hospitalization with intravenous (IV) corticosteroids treatment, history of bowel perforation and colectomy, recent toxic megacolon is exclusionary.
- 4. Participants should have acceptable hematologic, liver and renal function, no retinopathy or macular edema, diabetes mellitus should be controlled with HbA1c <9%.
- 5. No primary/secondary immunodeficiency, history of cancer or lymphoproliferative disorders, opportunistic infections.
- 6. No recent severe infections or chronic infections (eg, tuberculosis, viral hepatitis, human immunodeficiency virus [HIV]).
See the full eligibility criteria
- 1. Children ≥2 years to <12 years of age at the time of enrollment (Week 0/Day 1), who were diagnosed ≥4 weeks prior to screening with histologically and endoscopically confirmed active UC extending proximal to the rectum.
- 2. Participants must have moderately to severely active UC, defined as MMS of 5 to 9, including an ES ≥2 and RB subscore ≥1 prior to baseline (Day 1).
- 3. Participants must have demonstrated an inadequate response to, loss of response to, or intolerance to at least one of the conventional or biologic/Janus Kinase (JAK) inhibitor therapies.
- 1. Participants with any other type of inflammatory bowel disease (IBD) than UC cannot enroll.
- 2. Previous use of >2 advanced treatments (biologic or JAK inhibitors) is not allowed.
- 3. Present severe extensive UC, recent UC exacerbation that required hospitalization with intravenous (IV) corticosteroids treatment, history of bowel perforation and colectomy, recent toxic megacolon is exclusionary.
- 4. Participants should have acceptable hematologic, liver and renal function, no retinopathy or macular edema, diabetes mellitus should be controlled with HbA1c <9%.
- 5. No primary/secondary immunodeficiency, history of cancer or lymphoproliferative disorders, opportunistic infections.
- 6. No recent severe infections or chronic infections (eg, tuberculosis, viral hepatitis, human immunodeficiency virus [HIV]).
- 7. No signs of pulmonary obstruction.
- 8. No congenital heart disease, heart failure, arrythmias, symptomatic bradycardia, syncope or atrioventricular (AV) block.
- 9. Not allowed to enroll participants with infectious colitis, parasitic infection or positive Clostridioides difficile (C. diff) toxin test.
The study team makes the final eligibility decision.
Where it's taking place
- Israel
- Canada
- Japan
- Brazil
- Australia
- United States
- United Kingdom
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, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Israel; Canada; Japan; Brazil; Australia; United States and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.