Cure8 trial brief
This trial tests a new oral, gut-targeted small molecule that aims to protect intestinal mucosa and barrier function in ulcerative colitis — a different mechanism from many existing therapies. People with UC may be interested because it could expand future oral treatment options if proven safe and effective.
Adults with active ulcerative colitis, clinicians who treat IBD, and researchers focused on drug development for IBD.
This is a multicenter, randomized, double-blind, placebo-controlled Phase 2 study (planned n=80) that is currently recruiting.
The trial will evaluate safety, tolerability, pharmacokinetics, and clinical efficacy of once-daily oral ISM5411 tablets versus placebo for up to 12 weeks, with primary safety outcomes including treatment-emergent adverse events and serious adverse events.
The drug is described in the registry as a gut-restricted small-molecule PHD inhibitor intended to promote expression of intestinal mucosal protective genes and support barrier function alongside anti-inflammatory effects.
The registry entry lists standard inclusion/exclusion criteria for adults with documented ulcerative colitis and several infection, surgery, and comorbidity exclusions.
The entry is a ClinicalTrials.gov trial record (Phase 2, recruiting) and does not contain study results. Interpret as a description of study design and aims, not evidence of benefit or safety.
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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