NCT02808390

Efficacy and Safety Study of GED-0507-34-Levo for Treatment of UC

A Phase 2, Randomized, Placebo-controlled, Multicenter Study to Investigate the Efficacy and Safety of GED-0507-34-Levo (GED0507) for Treatment of Subjects With Active Ulcerative Colitis

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: PPM Services S.A. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of 2 doses of GED-0507-34-Levo in subjects with active, mild-to-moderate UC.

Detailed description

This is a Phase 2, Proof of Concept, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of 2 doses of GED-0507-34-Levo in subjects with active, mild-to-moderate Ulcerative Colitis. The study will consist of 3 phases: * Screening Phase - up to 4 weeks * Double-blind Placebo-controlled Phase - Weeks 0 to 8 * Follow-up Phase - Week 9

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
DRUG	GED-0507-34-Levo 80 mg	GED-0507-34-Levo 80 mg BID for 8 Weeks
DRUG	GED-0507-34-Levo 160 mg	GED-0507-34-Levo 160 mg BID for 8 Weeks
DRUG	Placebo	Placebo BID for 8 Weeks

Timeline

• Start date: 2016-11-28
• Primary completion: 2017-07-31
• Completion: 2017-07-31
• First posted: 2016-06-21
• Last updated: 2018-11-27
• Results posted: 2018-10-31

Locations

60 sites across 10 countries: United States, Bulgaria, Canada, France, Hungary, Italy, Latvia, Poland, Slovakia, Ukraine