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

Study acronym: ROCKETEER
StatusNot Yet Recruiting
PhasePhase 2
Started

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Record History

  1. Minor Study First Submitted
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.
Trial Details
NCT Number NCT07832435
Lead Sponsor Redx Pharma Ltd
Conditions
(from sponsor)
Strictures Due to Crohn's Disease
Related terms Constriction, Pathologic, Crohn Disease, Inflammatory Bowel Diseases
Enrollment 180 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov