Cure8 trial brief
This trial investigates a new oral medication (PALI-2108) for moderate-to-severe ulcerative colitis and could expand treatment options if later trials show benefit and safety. The study focuses on clinical remission at 12 weeks, a relevant short-term outcome for people with active UC.
Adults with moderate-to-severe ulcerative colitis, clinicians treating UC, researchers in inflammatory bowel disease, and patients who have failed or are intolerant of prior advanced therapies.
This is a registry entry for a randomized phase 2 interventional study that plans to enroll about 204 adults with endoscopically and histologically confirmed moderate-to-severe UC. Participants are randomized to one of two fixed oral doses of PALI-2108 (15 mg or 30 mg once daily) or placebo.
The primary endpoint is clinical remission at Week 12 measured by a 3-component modified Mayo Score that includes endoscopy, stool frequency, and rectal bleeding. The trial includes typical UC eligibility features (mMS 5–9, endoscopic subscore ≥2) and requires prior inadequate response or intolerance to prior therapies for many participants. Multiple U.S.
sites are listed and the record is marked as recruiting.
This is a ClinicalTrials.gov registration (phase 2, interventional). It describes planned enrollment, eligibility, dosing arms, and the prespecified primary endpoint but does not present study results. Interpret as a study design record only.
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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