Etrasimod for Ulcerative Colitis
(ELEVATE-UCkids Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores the safety and effectiveness of a drug called etrasimod for treating children with ulcerative colitis, a disease that causes inflammation and sores in the colon. The study targets children with moderate to severe symptoms and aims to understand how their bodies process the medication. Participants will take etrasimod orally each day for up to 52 weeks, with the option to continue treatment for up to four more years. Children who have been struggling with moderate to severe ulcerative colitis and are already on some UC treatments might be suitable candidates for this trial. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.
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's best to check with the trial coordinators for specifics on which medications are allowed.
Is there any evidence suggesting that etrasimod is likely to be safe for humans?
Research has shown that etrasimod is generally well-tolerated by people with ulcerative colitis. One study found that etrasimod had a safety record without major concerns. Another study demonstrated that etrasimod was safe and effective, with no unexpected side effects. Although specific side effects were not listed, participants found the treatment acceptable. This suggests that etrasimod could be a safe option for treating ulcerative colitis. However, individual experiences may vary, so discussing any concerns with a doctor is important.12345
Why do researchers think this study treatment might be promising for ulcerative colitis?
Etrasimod is unique because it represents a new way to tackle ulcerative colitis. Most current treatments, like mesalamine or corticosteroids, focus on reducing inflammation broadly. However, Etrasimod works differently by targeting a specific part of the immune system. It modulates the S1P receptor, which plays a role in immune cell movement, potentially reducing inflammation more precisely and with fewer side effects. Researchers are excited about Etrasimod because it could offer a more targeted approach, improving symptoms with potentially better safety and tolerability than existing options.
What evidence suggests that etrasimod might be an effective treatment for ulcerative colitis?
Research has shown that etrasimod can effectively manage symptoms of ulcerative colitis. In studies, nearly half of the participants experienced significant relief within 12 weeks. Specifically, by week 12, 48.7% of patients saw major improvements, with symptoms greatly reduced. Etrasimod also provided lasting benefits, as many patients maintained these improvements for up to two years. Improvements were noted in stool frequency and abdominal pain, regardless of previous treatments. This suggests that etrasimod holds strong potential for treating moderately to severely active ulcerative colitis.23678
Who Is on the Research Team?
Pfizer CT.gov Call Center
Principal Investigator
Pfizer
Are You a Good Fit for This Trial?
This trial is for children aged 2 to under 12 years who have been diagnosed with moderately to severely active ulcerative colitis. Kids with other types of bowel diseases, severe extensive colitis, or certain infections cannot join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive etrasimod by mouth, once daily for up to 52 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-Term Extension
Participants have the opportunity to continue in a Long-Term Extension (LTE) Period of up to 4 years
What Are the Treatments Tested in This Trial?
Interventions
- Etrasimod
Trial Overview
The study is testing a medicine called etrasimod to see how safe and effective it is in treating ulcerative colitis in children. Participants may continue treatment for up to five years if they benefit from the medication.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Etrasimod by mouth, once daily up to 52 weeks
Find a Clinic Near You
Who Is Running the Clinical Trial?
Pfizer
Lead Sponsor
Albert Bourla
Pfizer
Chief Executive Officer since 2019
PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki
Patrizia Cavazzoni
Pfizer
Chief Medical Officer
MD from McGill University
Citations
Effectiveness of etrasimod on disease activity and patient ...
Primary endpoints are symptomatic remission at week 12 and week 52. Secondary endpoints include patient-reported outcome 2 (combined rectal ...
Efficacy Data for VELSIPITY® (etrasimod) moderate to severe ...
Nearly half of patients achieved symptomatic remission* at week 12 · Percentage of patients with a ≥1-point decrease from baseline in Stool Frequency and Rectal ...
Efficacy of Etrasimod in Ulcerative Colitis: Analysis ...
Etrasimod demonstrated significant induction and maintenance efficacy over placebo in both moderate and severe endoscopic disease. Response to ...
P1030 Effectiveness and Safety of Etrasimod in Moderate to ...
Clinical remission was achieved in 48.7% (19/39) at week 12 and 69.2% (9/13) at week 24, with 46.1% (6/13) sustaining remission. Week-12 ...
5.
journals.lww.com
journals.lww.com/ajg/fulltext/2025/10002/s1687_long_term_efficacy_of_etrasimod_in_patients.1688.aspxS1687 Long-Term Efficacy of Etrasimod in Patients With...
Conclusion: Etrasimod efficacy was maintained through an additional 2 years of continuous treatment across clinical, endoscopic, and symptomatic outcomes, ...
Safety evaluation of etrasimod for ulcerative colitis based on ...
This study aims to assess the AEs of etrasimod in UC patients using data from the FDA Adverse Event Reporting System (FAERS) database. By ...
7.
gastroenterologyadvisor.com
gastroenterologyadvisor.com/news/etrasimod-safe-effective-in-management-of-ulcerative-colitis-regardless-of-bmi/Etrasimod Safe, Effective in Management of Ulcerative ...
The primary efficacy outcome was clinical remission, defined as a stool frequency subscore of 0, or 1 with at least a 1-point decrease from ...
Efficacy and Safety of Etrasimod in Patients with Ulcerative ...
In the Japan cohort, clinical remission was achieved by 14.3% (4/28) of patients who received etrasimod versus 7.1% (1/14) who received placebo at week 12. At ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.