NCT02337608

Efficacy and Safety of GLPG1205 in Subjects With Active Ulcerative Colitis

Phase II, Randomized, Double-Blind, Placebo-Controlled, Proof of Concept Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of GLPG1205 in Patients With Moderate to Severe Ulcerative Colitis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Galapagos NV · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

* Approximately 60 patients suffering from moderate to severe ulcerative colitis will be evaluated for improvement of disease activity (efficacy) when taking GLPG1205 or matching placebo once daily for 12 weeks in addition to their stable background treatment. * During the course of the study, patients will also be examined for any side effects that may occur (safety and tolerability), and the amount of GLPG1205 present in the blood (Pharmacokinetics) as well as the effects of GLPG1205 on disease- and mechanism of action-related parameters (Pharmacodynamics) in blood, stool and colonic biopsies will be determined.

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
DRUG	GLPG1205	GLPG1205 daily dosing in the morning for 12 weeks
DRUG	Placebo	placebo daily dosing in the morning daily for 12 weeks

Timeline

• Start date: 2014-12-01
• Primary completion: 2015-09-01
• Completion: 2015-11-01
• First posted: 2015-01-13
• Last updated: 2015-11-20

Locations

39 sites across 6 countries: Belgium, Czechia, Germany, Hungary, Poland, Russia