Cure8 trial brief
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 trials show benefit and safety.
Adult patients with moderate–severe UC, IBD clinicians, clinical researchers, and people following emerging UC therapies.
This ClinicalTrials.gov record describes a randomized, double-blind, placebo-controlled Phase 2 trial testing D-2570 in adults with moderately to severely active ulcerative colitis. The study plans to enroll about 120 participants across two parts (Part A includes a single-dose PK period; Part B expands to a larger efficacy cohort).
Participants are randomized 1:1:1 to two different D-2570 dose arms or placebo and will take study drug once daily for 12 weeks. The registered primary outcome is the proportion of subjects achieving clinical remission at Week 12, defined by a modified Mayo score (stool frequency, rectal bleeding, and endoscopic subscores).
The trial includes typical eligibility limits for UC trials: age 18–70, disease confirmed by endoscopy/histology, extent ≥15 cm, and moderate–severe activity by modified Mayo score. It excludes Crohn’s disease, prior colectomy, current dysplasia, certain infections, and other standard exclusions.
Concomitant 5-ASA or low-dose steroids are allowed if doses are stable. This listing is a trial record (Phase 2, active but not recruiting at the time of the registry snapshot) and describes study design, eligibility, interventions, and outcomes as registered. It does not report trial results or safety/efficacy findings.
Registry entries describe planned study methods and outcomes but do not present results. This record is Phase 2 and lists design details and eligibility; safety and efficacy are not reported here.
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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