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A Phase 2, Placebo-Controlled Study of Oral RXC008 for Crohn's Strictures
Sponsor: Redx Pharma Ltd
Summary
Crohn's disease (CD) is chronic inflammatory bowel disease where any part of the Gastrointestinal (GI) tract can become inflamed and develop fibrotic strictures. Intestinal strictures cause abdominal distension, cramping, dietary restrictions, nausea, vomiting, abdominal pain, and postprandial abdominal pain, which significantly impact patient quality of life. Rho-associated coiled-coil kinase (ROCK) family of proteins including ROCK1 and ROCK2 have been shown to play an important role in these fibrotic strictures. The investigational agent, RXC008, is an inhibitor of the activity of ROCK1 and ROCK2. The study will assess efficacy, safety, PK and PD of RXC008 in comparison with placebo for up to 48 weeks in participants with fibrotic strictures who are also receiving standard-of care background anti-inflammatory therapy.
Official title: Multicentre, Placebo-controlled Randomised, Double Blind, Phase 2 Study to Assess Efficacy, Safety, Tolerability and Pharmacokinetics of RXC008 in Participants With Strictures Due to Crohn's Disease Following Treatment With Orally Administered RXC008
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
180
Start Date
2026-10-01
Completion Date
2029-02-22
Last Updated
2026-09-22
Healthy Volunteers
No
Conditions
Interventions
High Dose
RXC008 High dose
Low Dose
RXC008: low dose
Placebo
Placebo