NCT07470879 A Study of How the Medicine Called "Etrasimod" Works in Children With the Gut Disease Called Ulcerative Colitis
| NCT ID | NCT07470879 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Pfizer |
| Condition | Colitis, Ulcerative |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2026-05-30 |
| Primary Completion | 2030-09-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 24 participants in total. It began in 2026-05-30 with a primary completion date of 2030-09-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 pediatrics participants (≥ 2 years up to \< 12 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).
Eligibility Criteria
Inclusion criteria: 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 Exclusion criteria: 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
Frequently Asked Questions
Who can join the NCT07470879 clinical trial?
This trial is open to participants of all sexes, aged 2 Years or older, up to 11 Years, studying Colitis, Ulcerative. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07470879 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07470879 currently recruiting?
Yes, NCT07470879 is actively recruiting participants. Visit ClinicalTrials.gov or contact Pfizer to inquire about joining.
Where is the NCT07470879 trial being conducted?
This trial is being conducted at Québec, Canada, Leipzig, Germany, Tübingen, Germany, Saitama-shi, Japan and 1 additional location.
Who is sponsoring the NCT07470879 clinical trial?
NCT07470879 is sponsored by Pfizer. The trial plans to enroll 24 participants.