Cure8 trial brief
This Phase 2 trial is testing a new oral drug (ATH-063) for adults with moderately to severely active ulcerative colitis who have not responded to prior biologic or advanced therapies, a group that often needs additional treatment options.
Adults with treatment-refractory UC, clinicians treating UC, and researchers interested in new oral therapies for inflammatory bowel disease.
This trial randomizes participants to ATH-063 150 mg once daily or matching placebo for a 12-week double-blind period, with an open-label extension offered afterward. The primary outcome is clinical remission at Week 12 measured by a specified UC disease severity score (UCDSS) including centrally read endoscopy.
Eligibility targets adults (18–75) with endoscopy- and histology-confirmed moderately to severely active UC who have failed 1–2 prior biologic/advanced therapies (one must have been an anti-TNF). The study includes screening labs and contraception requirements typical for Phase 2 interventional trials.
This is a ClinicalTrials.gov trial record describing design, eligibility, and endpoints; it does not report study results. The trial is currently recruiting.
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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