Ulcerative Colitis Clinical Trial
Official title:
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
- 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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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