Ulcerative Colitis Clinical Trial
Official title:
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
- 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.
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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