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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-005521-73 | EudraCT Number |
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GLPG0974 | Experimental | 1 capsule of 200 mg GLPG0974 twice daily |
|
| Placebo | Placebo Comparator | 1 capsule placebo twice daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GLPG0974 | Drug | 1 capsule in the morning and 1 capsule in the evening with food during 28 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of adverse events | To evaluate the safety and tolerability of GLPG0974 in terms of the number of adverse events reported | Screening up to Follow up (14 days after last dosing) |
| Changes in physical exam measures | To evaluate the safety and tolerability of GLPG0974 in terms of the changes in physical exam measures reported | Screening up to Follow up (14 days after last dosing) |
| Changes in vital signs as measured by heart rate, blood pressure and oral temperature | To evaluate the safety and tolerability of GLPG0974 in terms of the changes in vital signs as measured by heart rate, blood pressure and oral temperature reported | Screening up to Follow up (14 days after last dosing) |
| Changes in 12-lead ECG measures | To evaluate the safety and tolerability of GLPG0974 in terms of the changes in 12-lead ECG measures reported | Screening up to Follow up (14 days after last dosing) |
| Changes in blood safety lab parameters | To evaluate the safety and tolerability of GLPG0974 in terms of changes in blood safety lab parameters reported | Screening up to Follow up (14 days after last dosing) |
| Changes in urine safety lab parameters | To evaluate the safety and tolerability of GLPG0974 in terms of changes in urine safety lab parameters reported | Screening up to Follow up (14 days after last dosing) |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in (partial) Mayo clinical disease activity score | To evaluate the efficacy of GLPG0974 in terms of changes in (partial) Mayo clinical disease activity score reported | From Day 1 to Day 29 |
| Changes in histopathological clinical activity score in colon biopsies |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frédéric Vanhoutte, MD | Lakefront Biotherapeutics NV | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Imelda | Bonheiden | Belgium | ||||
| UZ Gent |
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| Placebo |
| Drug |
1 capsule in the morning and 1 capsule in the evening with food during 28 days |
|
To evaluate the efficacy of GLPG0974 in terms of changes in histopathological clinical activity score (Geboes score) in colon biopsies reported |
| Day 1 and Day 29 |
| The amount of GLPG0974 in plasma over time after multiple oral doses of GLPG0974 | To evaluate the amount of GLPG0974 in plasma over time after multiple oral doses of GLPG0974 - pharmacokinetics (PK) in ulcerative colitis patients | Day 8, Day 15 and Day 29 |
| Changes in the levels of faecal calprotectin over time after multiple oral doses of GLPG0974 | To evaluate the changes in the levels of calprotectin in faeces over time after multiple oral doses of GLPG0974 - pharmacodynamics (PD) in ulcerative colitis patients | Screening up to Day 29 |
| Changes in the levels of C-reactive protein in serum over time after multiple oral doses of GLPG0974 | To evaluate the changes in the levels of C-reactive protein in serum over time after multiple oral doses of GLPG0974 - pharmacodynamics (PD) in ulcerative colitis patients | Screening up to Day 29 |
| Changes in the levels of myeloperoxidase (MPO) in colon biopsies over time after multiple oral doses of GLPG0974 | To evaluate the changes in the levels of MPO in colon biopsies over time after multiple oral doses of GLPG0974 - pharmacodynamics (PD) in ulcerative colitis patients | Day 1 and Day 29 |
| Changes in the levels of predominant microbiota in faeces over time after multiple oral doses of GLPG0974 | To evaluate the changes in the levels of predominant microbiota in faeces over time after multiple oral doses of GLPG0974 - pharmacodynamics (PD) in ulcerative colitis patients | Day 1 and Day 29 |
| Changes in the levels of predominant microbiota in colon biopsies over time after multiple oral doses of GLPG0974 | To evaluate the changes in the levels of predominant microbiota in colon biopsies over time after multiple oral doses of GLPG0974 - pharmacodynamics (PD) in ulcerative colitis patients | Day 1 and Day 29 |
| Ghent |
| Belgium |
| AZ Groeninge | Kortrijk | Belgium |
| UZ Leuven | Leuven | Belgium |
| Hepato-Gastroenterologie HK, s.r.o. | Hradec Králové | Czechia |
| Fakulní nemocnice Olomouc | Olomouc | Czechia |
| Homolka Hospitál | Prague | Czechia |
| Nemocnice Slaný | Slaný | Czechia |
| Krajská zdravotní a.s., Masarykova nemocnice v Ústí nad Labem T. Bati a.s. | Ústí nad Labem | Czechia |
| Krajská nemocnice Tomáše Bati - Zlin | Zlín | Czechia |
| Nemocnice Znojmo | Znojmo | Czechia |
| Latvijas Jūras Medicīnas Centrs | Riga | Latvia |
| Rīgas slimnīca Bikor Holim | Riga | Latvia |
| SIA Gremošanas slimību centrs "Gastro" | Riga | Latvia |
| Univerzitná nemocnica Bratislava | Bratislava | Slovakia |
| Fakultná Nemocnica Nitra | Nitra | Slovakia |
| 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 |
|---|---|
| C000595478 | 4-(((R)-1-(benzo(b)thiophene-3-carbonyl)-2-methyl-azetidine-2-carbonyl)-(3-chloro-benzyl)-amino)-butyric acid |
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