Cure8 trial brief
This trial tests a new oral drug, AC-101, for moderate-to-severe ulcerative colitis and may expand future treatment options if it proves effective and safe. The study targets patients who have failed or could not tolerate prior therapies, a group with clear clinical need.
adult-patients;clinicians;researchers;patients-on-biologics
This ClinicalTrials.gov record describes a Phase 2, randomized, double-blind, placebo-controlled study testing AC-101 tablets in adults with moderately to severely active ulcerative colitis. The trial will compare two oral doses of AC-101, given twice daily, versus placebo over a 12-week induction period with a longer extension and safety follow-up.
Eligible participants must have endoscopy- and histology-confirmed UC (extent ≥ 15 cm from anal verge) and a modified Mayo Score consistent with moderate-to-severe disease, plus prior inadequate response/loss of response or intolerance to prior advanced or conventional therapies.
Key exclusions include severe extensive colitis, recent hospitalization for UC flare, presence of ostomy or fistula, recent use of certain biologics or immunosuppressive procedures, active infections (including TB, HBV, HCV, HIV), and recent live vaccination.
The registered primary outcome is clinical remission at Week 12 using stool frequency, rectal bleeding, and centrally read endoscopy subscores. Planned enrollment is 153 and the record is listed as not yet recruiting.
Registered as a Phase 2, not-yet-recruiting interventional study on ClinicalTrials.gov; the record describes planned design and eligibility but contains no efficacy or safety results.
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.
This trial tests an investigational oral therapy (D-2570) specifically in moderate–severe ulcerative colitis with a standard clinical remission endpoint at 12 weeks. Results could inform new treatment options if later...
This trial tests a new oral drug for moderate-to-severe ulcerative colitis and could expand treatment options if later shown to be safe and effective. It also targets patients who have had inadequate response or...
This trial tests whether adding an investigational oral agent (LY4268989) to mirikizumab improves remission rates in people with moderately to severely active ulcerative colitis. If successful, it could expand treatment...
