NCT05287126 A Study to Evaluate Etrasimod Treatment in Adolescents With Ulcerative Colitis
| NCT ID | NCT05287126 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Pfizer |
| Condition | Ulcerative Colitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 36 participants |
| Start Date | 2022-12-16 |
| Primary Completion | 2029-06-16 |
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 36 participants in total. It began in 2022-12-16 with a primary completion date of 2029-06-16.
⚠ 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 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).
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
Contact & Investigator
Pfizer CT.gov Call Center
STUDY DIRECTOR
Pfizer
Frequently Asked Questions
Who can join the NCT05287126 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, up to 17 Years, studying Ulcerative Colitis. 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 NCT05287126 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 NCT05287126 currently recruiting?
Yes, NCT05287126 is actively recruiting participants. Contact the research team at ClinicalTrials.gov_Inquiries@pfizer.com for enrollment information.
Where is the NCT05287126 trial being conducted?
This trial is being conducted at Little Rock, United States, Little Rock, United States, Garden Grove, United States, Loma Linda, United States and 11 additional locations.
Who is sponsoring the NCT05287126 clinical trial?
NCT05287126 is sponsored by Pfizer. The principal investigator is Pfizer CT.gov Call Center at Pfizer. The trial plans to enroll 36 participants.
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