Cure8 trial brief
Why This Matters
Fibrotic strictures are a major cause of symptoms and surgery in Crohn’s disease; an oral anti‑fibrotic drug could offer a non‑surgical treatment option if trials show benefit and safety. This study tests RXC008 specifically for strictures, using imaging, endoscopy, and patient symptom diaries to measure effects.
Who Should Pay Attention
Adults with Crohn’s disease and symptomatic small‑bowel strictures; gastroenterologists and IBD surgeons; researchers in anti‑fibrotic drug development.
Study Snapshot
What To Know
This ClinicalTrials.gov record describes a randomized, double-blind Phase 2 study of RXC008 — an oral, GI‑restricted inhibitor of ROCK1 and ROCK2 — for treating fibrotic strictures in adults with Crohn’s disease.
About 180 participants on stable anti‑inflammatory background therapy will be randomized 1:1:1 to high dose, low dose, or placebo and followed for up to 48 weeks; primary efficacy is change in stricture measured by MRE at Week 24.
Key assessments include central MRE reads, ileocolonoscopy to assess passability, daily patient-reported obstructive symptoms (S‑PRO2), and blood sampling for PK and safety.
The trial focuses specifically on fibrostenotic (structuring) Crohn’s disease rather than active penetrating disease; typical exclusion criteria include recent dilation or surgery, active fistula/abscess, and severe systemic disease. RXC008 is investigational; the record states the study is not yet recruiting.
Keep In Mind
Registry entry for a planned Phase 2 interventional study — describes design, eligibility, and planned assessments but contains no efficacy or safety results. RXC008 is investigational and not approved.
Source Details
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.