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NOT YET RECRUITING
NCT07832435
PHASE2

A Phase 2, Placebo-Controlled Study of Oral RXC008 for Crohn's Strictures

Sponsor: Redx Pharma Ltd

View on ClinicalTrials.gov

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

Interventions

DRUG

High Dose

RXC008 High dose

DRUG

Low Dose

RXC008: low dose

DRUG

Placebo

Placebo