Cure8 trial brief
Long-term extension studies collect additional safety and tolerability information and can provide continued access to an investigational drug for people who were in the parent trials.
For people with ulcerative colitis, this study focuses on etrasimod, an oral S1P receptor modulator being evaluated as a treatment option.
Adults and older adolescents with moderately to severely active ulcerative colitis who were participants in the listed parent studies; clinicians following patients on or considering etrasimod; researchers and trial participants interested in long-term safety data for S1P modulators.
This ClinicalTrials.gov record describes an open-label extension (OLE) study of etrasimod 2 mg once daily for people with moderately to severely active ulcerative colitis who previously participated in specified Phase 2 or Phase 3 parent studies.
The OLE will follow participants for up to approximately 8 years or until marketing authorization is granted in their country, with safety (adverse events) as a registered primary outcome. The study is Phase 3, interventional, labeled ACTIVE_NOT_RECRUITING with planned enrollment of 896 and broad adult eligibility (ages 16–80).
Participants must have come from qualifying parent trials (for example APD334-301, APD334-302, APD334-210) and meet those parent-study completion criteria to join the extension. Visits and procedures appear consistent with long-term safety follow-up; the registry entry lists multiple U.S.
study locations but does not summarize efficacy endpoints or specific safety findings here. This record reports the trial design and registration details rather than trial results.
This is a trial registry entry (trial-record). It describes the design, eligibility, interventions, and planned duration but does not report results. The record should be interpreted as a description of a registered ongoing/closed study rather than evidence of benefit or harm. If you are a participant or clinician, consult trial staff or the study protocol for full details.
Review the original publication for the complete reporting, methods, and context.
This Cure8 brief is based on source text from the linked article. Cure8 is informational only and is not a substitute for professional medical advice, diagnosis, or treatment.
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This trial tests etrasimod (an S1P receptor modulator) specifically in older adults with active ulcerative colitis — a group often underrepresented in IBD trials. Results could inform safety and short-term remission...
