NCT01829321

Safety, Efficacy, Pharmacokinetic and Pharmacodynamic Study of GLPG0974 in Subjects With Ulcerative Colitis

Exploratory, Phase II, Randomized, Double-blind, Placebo-controlled, Proof-of-Concept Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics and Pharmacodynamics of GLPG0974 in Subjects With Mild to Moderate Ulcerative Colitis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Galapagos NV · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

* Approximately 45 patients suffering from mild to moderate ulcerative colitis will be examined for any side effects (safety and tolerability) that may occur when taking GLPG0974 or matching placebo (2:1 ratio) for 28 days. * During the course of the study, patients will also be evaluated for improvement of disease activity by different efficacy measures, the amount of GLPG0974 present in the blood determined (PK) and the effects of GLPG0974 on selected biomarkers (PD) in the blood, colon biopsies and faeces will be explored.

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
DRUG	GLPG0974	1 capsule in the morning and 1 capsule in the evening with food during 28 days
DRUG	Placebo	1 capsule in the morning and 1 capsule in the evening with food during 28 days

Timeline

• Start date: 2013-04-01
• Primary completion: 2014-04-01
• Completion: 2014-04-01
• First posted: 2013-04-11
• Last updated: 2014-04-25

Locations

16 sites across 4 countries: Belgium, Czechia, Latvia, Slovakia