Cure8 trial brief
This trial tests a new oral drug for moderate to severe ulcerative colitis with a short (12-week) primary endpoint; people with active UC may be interested in emerging treatment options and clinical trial opportunities.
Adults with moderate to severe ulcerative colitis, gastroenterology clinicians, clinical researchers, and patients exploring clinical trial enrollment.
This is a ClinicalTrials.gov record for a phase 2, randomized, placebo-controlled study testing tilpisertib fosmecarbil (formerly GS-5290) as an oral treatment for adults with moderate to severe ulcerative colitis. The primary outcome is clinical response at Week 12 using a modified Mayo Clinic Score.
The study includes multiple blinded dose arms, a placebo arm, and provisions for non-responders to enter an open-label extension where responders can continue treatment up to Week 52.
The record lists planned enrollment (176), key inclusion criteria (age 18–75, confirmed UC by endoscopy and histology, disease extent ≥15 cm), and the dosing/response schema (Dose A/B/C with assessments at Week 12 and options for non-responders). Safety and efficacy assessments are part of the protocol but no results are reported in this registry entry.
If you’re considering trial participation, speak with your clinical team about eligibility and what participation involves; registry entries are study plans, not evidence that the drug is effective or approved.
This is a trial registry entry (phase 2, ACTIVE_NOT_RECRUITING) describing the study design and planned outcomes; it does not report results. Tilpisertib fosmecarbil is investigational and not approved for UC. Enrollment, eligibility, and study procedures are defined by the protocol and may change; consult the trial site or sponsor for current 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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