drugset / Trial / NCT02337608

Efficacy and Safety of GLPG1205 in Subjects With Active Ulcerative Colitis

NCT02337608

Phase 2 Completed 64 enrolled Lakefront Biotherapeutics NV
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2014-12
Primary completion
2015-09
Completion
2015-11

Drugs

EvaluationDrugModalityDoseRoute
Subject GLPG1205 Small molecule 100 mg

Indications