drugset / Trial / NCT01829321

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

NCT01829321 ↗

Phase 2 Completed 45 enrolled Lakefront Biotherapeutics NV
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2013-04
Primary completion
2014-04
Completion
2014-04

Drugs

EvaluationDrugModalityDoseRoute
Subject GLPG0974 Small molecule 200 mg —

Indications