* 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
64
Changes in Mayo score at Week 8
To evaluate the efficacy of GLPG1205 in terms of changes in Mayo score comparing results at Week 8 with baseline between GLPG1205 treated subjects and placebo subjects
Time frame: Screening and Week 8
Changes in partial Mayo score
To evaluate the efficacy of GLPG1205 in terms of changes in partial Mayo score comparing results with baseline between GLPG1205 treated subjects and placebo subjects at every visit up to Week 12
Time frame: From Screening to Week 12
Histological response rate
To evaluate the efficacy of GLPG1205 in terms of histological response rate by use of the histopathological Geboes index comparing results at Week 8 with baseline between GLPG1205 treated subjects and placebo subjects
Time frame: Screening and Week 8
Number of subjects with adverse events
To evaluate the safety and tolerability of GLPG1205 between GLPG1205 treated subjects and placebo subjects in terms of adverse events at every visit
Time frame: From Screening to Week 16
Number of subjects with abnormal laboratory parameters
To evaluate the safety and tolerability of GLPG1205 between GLPG1205 treated subjects and placebo subjects in terms of abnormal laboratory parameters at every visit
Time frame: From Screening to Week 16
Number of subjects with abnormal vital signs
To evaluate the safety and tolerability of GLPG1205 between GLPG1205 treated subjects and placebo subjects in terms of abnormal vital signs at every visit
Time frame: From Screening to Week 16
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St. Pierre University Hospital Center
Brussels, Belgium
Leuven University Hospital
Leuven, Belgium
Clinic Saint-Joseph
Liège, Belgium
Hepato-Gastroenterology HK Ltd.
Hradec Králové, Czechia
Outpatient Clinic of Internal Medicine and Gastroenterology
Pilsen, Czechia
Orlickoustecka Hospital, Inc.
Ústí nad Orlicí, Czechia
Regional Hospital T. Bata, Clinic of Internal Medicine
Zlín, Czechia
Hospital Znojmo
Znojmo, Czechia
Gastroenterology Specialist Practice
Berlin, Germany
Asklepios West Hospital Hamburg, Clinic of Internal Medicine
Hamburg, Germany
...and 29 more locations
Number of subjects with abnormal electrocardiogram
To evaluate the safety and tolerability of GLPG1205 between GLPG1205 treated subjects and placebo subjects in terms of abnormal electrocardiograms at every visit
Time frame: From Screening to Week 16
Number of subjects with abnormal physical examination
To evaluate the safety and tolerability of GLPG1205 between GLPG1205 treated subjects and placebo subjects in terms of abnormal physical examination at every visit
Time frame: From Screening to Week 16
The plasma levels of GLPG1205
To characterize the pharmacokinetics (PK) of GLPG1205 by measuring the amount in plasma at Week 4, 8 and 12
Time frame: Week 4, 8 and 12
Changes in serum C-reactive protein (CRP) levels
To characterize the pharmacodynamics (PD) of GLPG1205 by measuring the levels of C-reactive protein in serum at every visit
Time frame: From Screening to Week 16
Changes in faecal calprotectin levels
To characterize the pharmacodynamics (PD) of GLPG1205 by measuring the levels of faecal calprotectin in stool at every visit up to Week 12
Time frame: From Screening to Week 12
Changes in myeloperoxidase (MPO) levels in colonic biopsies
To characterize the pharmacodynamics (PD) of GLPG1205 by measuring the levels of myeloperoxidase (MPO) in colonic biopsies at Screening and Week 8
Time frame: Screening and Week 8