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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-002857-32 | EudraCT Number |
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GLPG0634 200 mg QD | Experimental | 2 tablets of 100 mg GLPG0634 in the morning |
|
| GLPG0634 100 mg QD | Experimental | 1 tablet of 100 mg GLPG0634 and 1 placebo tablet in the morning |
|
| Placebo QD | Placebo Comparator | 2 placebo tablets in the morning |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GLPG0634 | Drug | 100 mg oral tablet, intake once daily for 20 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects achieving clinical remission at Week 10 | Percentage of subjects achieving clinical remission as defined by a Crohn's Disease Activity Index score < 150 points | Week 10 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects achieving clinical remission | Percentage of subjects achieving clinical remission as defined by a Crohn's Disease Activity Index score < 150 points, assessed at every visit | Up to Week 20 |
| Percentage of subjects achieving clinical response |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pille Harrison, MD | Lakefront Biotherapeutics NV | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Pierre University Hospital Center | Brussels | Belgium | ||||
| University Hospital Saint Luc |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35762272 | Derived | Reinisch W, Serone A, Hebuterne X, Kuhbacher T, Klopocka M, Roblin X, Brodbeck J, Etchevers K, Galien R, Grant E, Tasset C, Yoon OK, Zaboli S, Vermeire S. Mucosal p-STAT1/3 correlates with histologic disease activity in Crohn's disease and is responsive to filgotinib. Tissue Barriers. 2023 Apr 3;11(2):2088961. doi: 10.1080/21688370.2022.2088961. Epub 2022 Jun 28. | |
| 27988142 |
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| Placebo | Drug | placebo oral tablets, intake once daily for 20 weeks |
|
|
Percentage of subjects achieving clinical response as defined by a decrease in Crohn's Disease Activity Index score of at least 100 points, assessed at every visit |
| Up to Week 20 |
| Percentage of subjects achieving endoscopic remission at Week 10 | Percentage of subjects achieving endoscopic remission as defined by a reduction of Simplified Endoscopy Score for Crohn's Disease (SES-CD) score ≤ 4, with ulcerated surface subscore no greater than 1 in any segment at Week 10 | Week 10 |
| Percentage of subjects achieving endoscopic response at Week 10 | Percentage of subjects achieving endoscopic response as defined by a reduction of Simplified Endoscopy Score for Crohn's Disease (SES-CD) score by at least 50% from Screening at Week 10 | Week 10 |
| Percentage of subjects achieving mucosal healing at Week 10 | Percentage of subjects achieving mucosal healing as defined by a Simplified Endoscopy Score for Crohn's Disease (SES-CD) score equal to 0 at Week 10 | Week 10 |
| Change from Baseline in Crohn's Disease Activity Index score | Change from Baseline in Crohn's Disease Activity Index score, assessed at every visit | Up to Week 20 |
| Change from Screening in endoscopic score | Change from Screening in endoscopic Simplified Endoscopy Score for Crohn's Disease (SES-CD) score at Week 10 | Week 10 |
| Change from Screening in histopathology biopsy score | Change from Screening in histopathology biopsy score at Week 10 | Week 10 |
| Change from Baseline in Subjects' Quality of Life (based on the Inflammatory Bowel Disease Questionnaire (IBDQ) questionnaire score) | Change from Baseline in Subjects' Quality of Life based on the IBDQ questionnaire score at Week 10 and Week 20 | Up to Week 20 |
| The number of subjects with adverse events | To evaluate the safety and tolerability of GLPG0634 in comparison with placebo in terms of adverse events (AEs) | From screening up to 2 weeks after last dose |
| The number of subjects with abnormal lab tests | To evaluate the safety and tolerability of GLPG0634 in comparison with placebo in terms laboratory test abnormalities | From screening up to 2 weeks after last dose |
| The number of subjects with abnormal vital signs | To evaluate the safety and tolerability of GLPG0634 in comparison with placebo in terms of abnormalities in vital signs | From screening up to 2 weeks after last dose |
| The number of subjects with abnormal ECG | To evaluate the safety and tolerability of GLPG0634 in comparison with placebo in terms of abnormalities in electrocardiogram (ECG) | From screening up to 2 weeks after last dose |
| The plasma levels of GLPG0634 and its metabolite | To characterize the pharmacokinetics (PK) of GLPG0634 and its metabolite by measuring the amount in plasma from Week 2 up to Week 20 at every visit | Up to Week 20 |
| The change versus Baseline in levels of immune- and inflammation-related parameters in whole blood and serum | To characterize the pharmacodynamics (PD) of GLPG0634 and its metabolite by measuring the levels of immune- and inflammation-related parameters in whole blood and serum | Up to Week 20 |
| The change versus Baseline in levels of faecal calprotectin | To characterize the pharmacodynamics (PD) of GLPG0634 and its metabolite by measuring the levels of faecal calprotectin | Up to Week 20 |
| The change versus Baseline in microbial communities in stool samples | To characterize the effects of GLPG0634 and its metabolite on the microbial communities by measuring the levels of predominant microbiota in stool samples | Up to Week 10 |
| Brussels |
| Belgium |
| University Hospital Ghent | Ghent | Belgium |
| University Hospitals Leuven | Leuven | Belgium |
| CHR de la Citadelle | Liège | Belgium |
| Clinic Saint Joseph | Liège | Belgium |
| Hepato-Gastroenterology HK Ltd. | Hradec Králové | Czechia |
| University Hospital Olomouc | Olomouc | Czechia |
| Outpatient Clinic of Internal Medicine and Gastroenterology | Pilsen | Czechia |
| Institute of Clinical and Experimental Medicine | Prague | Czechia |
| Masaryk's Hospital Usti Nad Labem | Ústí nad Labem | Czechia |
| Hospital Znojmo | Znojmo | Czechia |
| Hospital Gabriel Montpied | Clermont-Ferrand | France |
| Beaujon Hospital | Clichy | France |
| Dijon University Hospital Center | Dijon | France |
| Hospital Michallon | Grenoble | France |
| Lille Regional University Hospital Center | Lille | France |
| North Hospital | Marseille | France |
| Archet Hospital | Nice | France |
| Saint Etienne University Hospital Center | Saint-Etienne | France |
| DRK Clinics Berlin Westend | Berlin | Germany |
| Interdisciplinary Crohn Colitis Center Rhein Main | Frankfurt am Main | Germany |
| Asklepios West Hospital Hamburg | Hamburg | Germany |
| University Hospital Jena | Jena | Germany |
| University Hospital Schleswig-Holstein | Kiel | Germany |
| University Hospital Magdeburg | Magdeburg | Germany |
| Gastroenterology Group Practice Minden | Minden | Germany |
| Internal Medicine Group Practice Oldenburg | Oldenburg | Germany |
| Drug Research Center Ltd. | Balatonfüred | Hungary |
| Clinexpert Medical Center | Budapest | Hungary |
| Semmelweis University | Budapest | Hungary |
| Szent Margit Hospital | Budapest | Hungary |
| University of Debrecen, Medical and Health Science Center | Debrecen | Hungary |
| Bekes County Pandy Kalman Hospital | Gyula | Hungary |
| Tolna County Balassa Janos Hospital | Szekszárd | Hungary |
| Jan Biziel University Hospital #2 | Bydgoszcz | Poland |
| Saint Family Hospital Medical Center | Lodz | Poland |
| H-T. Medical Center | Tychy | Poland |
| Clinical Hospital of Ministry of Internal Affairs and Administration | Warsaw | Poland |
| Maternal, Pediatric and Adolescent Healtcare Centre, Gastroenterology Diagnostic Facility for Adults | Warsaw | Poland |
| Vivamed | Warsaw | Poland |
| Active Health Center | Wroclaw | Poland |
| Colentina Clinical Hospital | Bucharest | Romania |
| Fundeni Clinical Institute | Bucharest | Romania |
| Medical Center for Gastroenterology | Cluj-Napoca | Romania |
| Center for Gastroenterology, Ltd | Timișoara | Romania |
| Territorial Clinical Hospital | Barnaul | Russia |
| State Medical University | Kazan' | Russia |
| Territorial Clinical Hospital | Krasnoyarsk | Russia |
| A.N. Ryzhikh State Research Center for Coloproctology | Moscow | Russia |
| City Clinical Hospital #24 | Moscow | Russia |
| Moscow Clinical Research Center | Moscow | Russia |
| Vladimirsky Regional Clinical Research Institute | Moscow | Russia |
| Semashko Nizhny Novgorod Regional Clinical Hospital | Nizhny Novgorod | Russia |
| City Clinical Hospital #12 | Novosibirsk | Russia |
| City Clinical Hospital #31 | Saint Petersburg | Russia |
| First Pavlov State Medical University | Saint Petersburg | Russia |
| Mechnikov North-Western State Medical University | Saint Petersburg | Russia |
| St. Elizabeth City Hospital | Saint Petersburg | Russia |
| Queen Elizabeth Hospital | Birmingham | United Kingdom |
| Royal Bournemouth Hospital | Bournemouth | United Kingdom |
| St Mark's Hospital | Harrow | United Kingdom |
| Manchester Royal Infirmary | Manchester | United Kingdom |
| Vermeire S, Schreiber S, Petryka R, Kuehbacher T, Hebuterne X, Roblin X, Klopocka M, Goldis A, Wisniewska-Jarosinska M, Baranovsky A, Sike R, Stoyanova K, Tasset C, Van der Aa A, Harrison P. Clinical remission in patients with moderate-to-severe Crohn's disease treated with filgotinib (the FITZROY study): results from a phase 2, double-blind, randomised, placebo-controlled trial. Lancet. 2017 Jan 21;389(10066):266-275. doi: 10.1016/S0140-6736(16)32537-5. Epub 2016 Dec 15. |
| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| C584571 | GLPG0634 |
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