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

Ulcerative Colitis Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial 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 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02808390
Study type Interventional
Source PPM Services S.A.
Contact
Status Terminated
Phase Phase 2
Start date November 28, 2016
Completion date July 31, 2017
View Details
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