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Phase 2a Study of PRV-6527 in Subjects With Moderately to Severely Active Crohn's Disease — PRINCE  

Crohn's Disease Clinical Trial

Official title:
Phase 2a Multicenter Randomized Double-Blind Placebo-Controlled Parallel Study to Evaluate the Efficacy and Safety of Oral PRV-6527 (JNJ-40346527), an Inhibitor of CSF-1 Receptor, in Subjects With Moderately to Severely Active Crohn's

Clinical Trial Summary

This study will evaluate the efficacy and safety of oral PRV-6527 in the treatment of moderately to severely active Crohn's disease

Clinical Trial Description

This is a Phase 2a, randomized, double-blind, placebo-controlled, parallel-group, multicenter study in adult subjects with moderately to severely active Crohn's disease. Eligible subjects include males and females aged 18-75 years with moderately to severely active CD for at least 3 months. Each subject will receive the assigned treatment over 12 weeks, followed by a 4-week safety follow-up period. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03854305
Study type Interventional
Source Provention Bio, Inc.
Contact
Status Completed
Phase Phase 2
Start date March 20, 2018
Completion date August 13, 2019
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