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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-001893-32 | EudraCT Number |
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GLPG1205 100mg QD | Experimental | GLPG1205 100mg daily dosing in the morning |
|
| Placebo | Placebo Comparator | Placebo daily dosing in the morning |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GLPG1205 | Drug | GLPG1205 daily dosing in the morning for 12 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Screening and Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | From Screening to Week 12 |
| Histological response rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frédéric Vanhoutte, MD | Lakefront Biotherapeutics NV | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Pierre University Hospital Center | Brussels | Belgium | ||||
| Leuven University Hospital |
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| Placebo |
| Drug |
placebo daily dosing in the morning daily for 12 weeks |
|
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 |
| 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 | 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 | 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 | From Screening to Week 16 |
| 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 | 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 | 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 | 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 | 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 | 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 | Screening and Week 8 |
| 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 |
| Hannover Medical School | Hanover | Germany |
| University Hospital Jena | Jena | Germany |
| Gastroenterology Group Practice Minden | Minden | Germany |
| Gastroenterology Practice at Germania-Campus | Münster | Germany |
| Internal Medicine Group Practice Oldenburg | Oldenburg | Germany |
| Clinexpert Medical Center | Budapest | Hungary |
| Hungarian Center for Obesity Ltd. | Budapest | Hungary |
| Medical Centre, Hungarian Defence Forces | Budapest | Hungary |
| Szent Margit Hospital | Budapest | Hungary |
| Main Railway Outpatient Clinic Debrecen | Debrecen | Hungary |
| Javorszky Odon Hospital | Vác | Hungary |
| Healthcare Center Orkan Med Stec Michalska Spolka Jawna | Ksawerów | Poland |
| Saint Family Hospital Medical Center | Lodz | Poland |
| Sopmed Llc | Sopot | Poland |
| H-T Medical Center | Tychy | Poland |
| Maternal, Pediatric and Adolescent Healtcare Centre, Gastroenterology Diagnostic Facility for Adults | Warsaw | Poland |
| Vivamed | Warsaw | Poland |
| Active Health Center, Non-Public Healthcare Facility Zawidawie Center | Wroclaw | Poland |
| Kazan State Medical University | Kazan' | Russia |
| Territorial Clinical Hospital | Krasnoyarsk | Russia |
| Central Research Institute of Gastroenterology | Moscow | Russia |
| Moscow Vladimirsky Regional Clinical Research Institute | Moscow | Russia |
| Semashko Nizhny Novgorod Regional Clinical Hospital | Nizhny Novgorod | Russia |
| City Clinical Hospital #12 | Novosibirsk | Russia |
| Penza Regional Clinical Hospital n.a. N. N. Burdenko | Penza | Russia |
| City Clinical Hospital #31 | Saint Petersburg | Russia |
| City General Hospital #2 | Saint Petersburg | Russia |
| St. Venerable Martyress Elizabeth Municipal Hospital | Saint Petersburg | Russia |
| Stavropol State Medical University | Stavropol | Russia |
| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D015212 | Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| C000722907 | GLPG1205 |
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