NCT03854305

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 93 (actual)
• Sponsor: Provention Bio, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Crohn's Disease

Interventions

Type	Name	Description
DRUG	PRV-6527	Treatment
DRUG	Placebo	Comparator

Timeline

• Start date: 2018-03-20
• Primary completion: 2019-08-13
• Completion: 2019-08-13
• First posted: 2019-02-26
• Last updated: 2021-09-16

Locations

51 sites across 7 countries: Austria, Germany, Hungary, Poland, Russia, Spain, Ukraine