Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2025-12-25 @ 10:01 PM
Study NCT ID:
NCT05479058
Status:
TERMINATED
Last Update Posted:
2024-10-04
First Post:
2022-07-26
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study Evaluating the Effect of Filgotinib Dose De-escalation in Participants With Ulcerative Colitis (UC) in Remission
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003093', 'term': 'Colitis, Ulcerative'}], 'ancestors': [{'id': 'D003092', 'term': 'Colitis'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C584571', 'term': 'GLPG0634'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'medicalinfo@glpg.com', 'phone': '+32 15 342 900', 'title': 'Galapagos Medical Information', 'organization': 'Galapagos N.V.'}, 'certainAgreement': {'otherDetails': 'The sponsor must review and approve any results of the study or abstracts for professional meetings prepared by the investigator(s). Published data must not compromise the objectives of the study. Data from individual study centers in multicenter studies must not be published separately.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'This study was terminated as the planned number of participants needed to ensure adequate precision in the estimations and to draw meaningful conclusions was unlikely to be met, questioning the scientific value and ethical grounds for study continuation.'}}, 'adverseEventsModule': {'timeFrame': 'Baseline up to Week 48', 'description': 'The Safety Analysis Set included all randomized participants who were administered study drug at least once.', 'eventGroups': [{'id': 'EG000', 'title': 'Filgotinib 200 mg', 'description': 'Participants received filgotinib 200 mg and placebo to match filgotinib 100 mg once daily orally.', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 6, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Filgotinib 100 mg', 'description': 'Participants received filgotinib 100 mg and placebo to match filgotinib 200 mg once daily orally.', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 6, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Campylobacter infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Laryngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Colitis ulcerative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Bursitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Tendonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Hypercholesterolaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Vitamin D deficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Tendon rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Liver function test abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Renal colic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Actinic keratosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Postmenopause', 'notes': 'This is a sex-specific AE. Only female participants were at risk.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Social circumstances', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants in Corticosteroid-free Clinical Remission Based on Modified Mayo Clinical Score (mMCS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Filgotinib 200 mg', 'description': 'Participants received filgotinib 200 mg and placebo to match filgotinib 100 mg once daily orally.'}, {'id': 'OG001', 'title': 'Filgotinib 100 mg', 'description': 'Participants received filgotinib 100 mg and placebo to match filgotinib 200 mg once daily orally.'}], 'timeFrame': 'Week 48', 'description': 'The mMCS is a tool designed to measure disease activity for ulcerative colitis. The mMCS was calculated as the sum of the 3 subscores: stool frequency, rectal bleeding, and endoscopy. Each subscore was graded from 0 to 3 with higher scores indicating more severe disease activity. The total mMCS score ranged from 0 to 9 with higher scores indicating more severe disease activity.\n\nThe mMCS remission was defined as a total score of score ≤2, with endoscopic subscore of ≤1, stool frequency subscore of ≤1, and a rectal bleeding subscore of 0.\n\nCorticosteroid-free mMCS remission was defined as being free of corticosteroids for at least 12 weeks.', 'reportingStatus': 'POSTED', 'populationDescription': 'As the study was terminated prior to any participant reaching the primary analysis time point at Week 48, the data for this endpoint was not collected and analyzed.'}, {'type': 'SECONDARY', 'title': 'Time to Patient-Reported Outcome Based on 2 Items (PRO2) Flare', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Filgotinib 200 mg', 'description': 'Participants received filgotinib 200 mg and placebo to match filgotinib 100 mg once daily orally.'}, {'id': 'OG001', 'title': 'Filgotinib 100 mg', 'description': 'Participants received filgotinib 100 mg and placebo to match filgotinib 200 mg once daily orally.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Due to insufficient number of participants with PRO2 flare, the median and 95% CI data could not be calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Due to insufficient number of participants with PRO2 flare, the median and 95% CI data could not be calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline up to Week 48', 'description': 'PRO2 flare was defined as a PRO2 score worsening of at least 2 points and an absolute PRO2 score of at least 3, with stool frequency subscore ≥2, and rectal bleeding subscore ≥1.\n\nPRO2 included items of stool frequency and rectal bleeding. The range of each item score was 0 to 3 with higher scores indicating more severe disease.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set (FAS) (all randomized participants who were administered study drug at least once) were analyzed.'}, {'type': 'SECONDARY', 'title': 'Time to ES-Confirmed UC Flare', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Filgotinib 200 mg', 'description': 'Participants received filgotinib 200 mg and placebo to match filgotinib 100 mg once daily orally.'}, {'id': 'OG001', 'title': 'Filgotinib 100 mg', 'description': 'Participants received filgotinib 100 mg and placebo to match filgotinib 200 mg once daily orally.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Due to insufficient number of participants with ES-confirmed UC flare, the median and 95% CI data could not be calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Due to insufficient number of participants with ES-confirmed UC flare, the median and 95% CI data could not be calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline up to Week 48', 'description': 'An ES-confirmed UC flare was defined as an increase in rectal bleeding subscore by at least 1 point and an increase in stool frequency subscore by at least 2 points and an increase in endoscopic subscore by at least 1 point. Each subscore graded from 0 to 3 with higher scores indicating more severe disease.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the FAS were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in C-Reactive Protein (CRP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Filgotinib 200 mg', 'description': 'Participants received filgotinib 200 mg and placebo to match filgotinib 100 mg once daily orally.'}, {'id': 'OG001', 'title': 'Filgotinib 100 mg', 'description': 'Participants received filgotinib 100 mg and placebo to match filgotinib 200 mg once daily orally.'}], 'classes': [{'title': 'Change at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.166', 'spread': '0.533', 'groupId': 'OG000'}, {'value': '1.713', 'spread': '4.423', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.532', 'spread': '1.128', 'groupId': 'OG000'}, {'value': '10.406', 'spread': '26.944', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.156', 'spread': '0.128', 'groupId': 'OG000'}, {'value': '16.002', 'spread': '34.093', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.367', 'spread': '0.192', 'groupId': 'OG000'}, {'value': '1.443', 'spread': '0.525', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 4, Week 12, Week 24, Week 36, and Week 48', 'description': 'CRP is an acute-phase protein which provides an objective criterion of inflammatory activity.', 'unitOfMeasure': 'milligrams per liter (mg/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the FAS with available data were analyzed. As the study was terminated prior to any participant reaching the Week 48 time point, the data for Week 48 time point was not collected and analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fecal Calprotectin (FCP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Filgotinib 200 mg', 'description': 'Participants received filgotinib 200 mg and placebo to match filgotinib 100 mg once daily orally.'}, {'id': 'OG001', 'title': 'Filgotinib 100 mg', 'description': 'Participants received filgotinib 100 mg and placebo to match filgotinib 200 mg once daily orally.'}], 'classes': [{'title': 'Change at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-27.6', 'spread': '37.2', 'groupId': 'OG000'}, {'value': '142.5', 'spread': '307.7', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-16.7', 'spread': '48.1', 'groupId': 'OG000'}, {'value': '920.6', 'spread': '1996.2', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-52.0', 'spread': '54.6', 'groupId': 'OG000'}, {'value': '374.3', 'spread': '674.8', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-46.5', 'spread': '65.8', 'groupId': 'OG000'}, {'value': '-8.0', 'spread': '70.4', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 4, Week 12, Week 24, Week 36, and Week 48', 'description': 'Fecal calprotectin, a very stable biomarker, was a 36 kilodalton calcium and zinc binding protein of S-100 protein family which was neutrophil derived. It represents 60% of cytosolic proteins in neutrophils and was a measurement of neutrophil migration to the gastrointestinal tract.', 'unitOfMeasure': 'milligrams per kilogram (mg/kg)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the FAS with available data were analyzed. As the study was terminated prior to any participant reaching the Week 48 time point, the data for Week 48 time point was not collected and analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Filgotinib 200 mg', 'description': 'Participants received filgotinib 200 mg and placebo to match filgotinib 100 mg once daily orally.'}, {'id': 'OG001', 'title': 'Filgotinib 100 mg', 'description': 'Participants received filgotinib 100 mg and placebo to match filgotinib 200 mg once daily orally.'}], 'timeFrame': 'Baseline, Week 48', 'description': 'The IBDQ is disease-specific questionnaire used for an assessment of Health Related Quality of Life (HRQoL) in participants with the Inflammatory Bowel Disease (IBD). It comprised of 32 questions divided into four health subscales: bowel symptoms (10 questions); systemic symptoms, including sleep disorders and fatigue (5 questions); emotional function such as depression, aggression, and irritation (12 questions); and social function, meaning the ability to participate in social activities and to work (5 questions). The IBDQ total score was calculated as the sum of the responses (each ranging from 1 \\[severe problem\\] to 7 \\[normal health\\]) to all 32 questions. Total IBDQ score ranged from 32 to 224 with a higher score indicating a better HRQoL.', 'reportingStatus': 'POSTED', 'populationDescription': 'As the study was terminated prior to any participant reaching the Week 48 time point, the data for this endpoint was not collected and analyzed.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (SAEs), and TEAEs Leading to Treatment Discontinuation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Filgotinib 200 mg', 'description': 'Participants received filgotinib 200 mg and placebo to match filgotinib 100 mg once daily orally.'}, {'id': 'OG001', 'title': 'Filgotinib 100 mg', 'description': 'Participants received filgotinib 100 mg and placebo to match filgotinib 200 mg once daily orally.'}], 'classes': [{'title': 'TEAEs', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Serious TEAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'TEAEs Leading to Treatment Discontinuation', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to Week 48', 'description': 'An adverse event (AE) was any untoward medical occurrence, new or worsening of any preexisting condition, in a clinical study participant administered a medicinal product and which did not necessarily had to have a causal relationship with this treatment.\n\nA TEAE was defined as\n\n* An AE which had a start date equal to or after the date of the first administration of study drug in this study and no later than 30 days after last administration of study drug.\n* And was either a newly reported event, or a worsening of an existing event.\n\nSerious TEAE was defined as a TEAE that\n\n* Resulted in death and was life-threatening;\n* Required in-patient hospitalization or prolongation of existing hospitalization;\n* Resulted in persistent or significant disability/incapacity;\n* Was a congenital anomaly / birth defect;\n* Was medically significant.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Safety analysis set were analyzed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Filgotinib 200 mg', 'description': 'Participants received filgotinib 200 mg and placebo to match filgotinib 100 mg once daily orally.'}, {'id': 'FG001', 'title': 'Filgotinib 100 mg', 'description': 'Participants received filgotinib 100 mg and placebo to match filgotinib 200 mg once daily orally.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '11'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Study terminated by sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}]}]}], 'recruitmentDetails': 'Participants who were in clinical remission with filgotinib 200 milligrams (mg) once daily for at least 2 consecutive quarterly visits in the ongoing long-term extension (LTE) SELECTION-LTE study (GS-US-418-3899; NCT02914535) and who met the eligibility criteria, were rolled over and randomized to this study. Participants were enrolled at study sites in Poland, France, Germany, the United States, Belgium, Republic of Korea, Spain, and the United Kingdom.', 'preAssignmentDetails': 'The clinical trial was originally designed with the primary endpoint to be assessed at Week 48 after which participants would have received unblinded treatment. Due to early termination of the study, none of the participants completed 48 weeks of treatment. All participants participated in blinded treatment period only and the study was unblinded globally after study completion.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Filgotinib 200 mg', 'description': 'Participants received filgotinib 200 mg and placebo to match filgotinib 100 mg once daily orally.'}, {'id': 'BG001', 'title': 'Filgotinib 100 mg', 'description': 'Participants received filgotinib 100 mg and placebo to match filgotinib 200 mg once daily orally.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56.5', 'spread': '8.5', 'groupId': 'BG000'}, {'value': '58.3', 'spread': '10.7', 'groupId': 'BG001'}, {'value': '57.4', 'spread': '9.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Safety Analysis Set included all randomized participants who were administered study drug at least once.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-03-17', 'size': 7830256, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-09-09T02:58', 'hasProtocol': True}, {'date': '2024-01-05', 'size': 8136873, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-09-09T02:59', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The study was double-blinded to treatment assignment until the last subject has reached the primary analysis time point.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'whyStopped': 'the planned number of participants needed to ensure adequate precision in the estimations and to draw meaningful conclusions was unlikely to be met, questioning the scientific value and ethical grounds for study continuation', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2022-07-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2023-10-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-09', 'studyFirstSubmitDate': '2022-07-26', 'resultsFirstSubmitDate': '2024-09-09', 'studyFirstSubmitQcDate': '2022-07-26', 'lastUpdatePostDateStruct': {'date': '2024-10-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-09-09', 'studyFirstPostDateStruct': {'date': '2022-07-29', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-10-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants in Corticosteroid-free Clinical Remission Based on Modified Mayo Clinical Score (mMCS)', 'timeFrame': 'Week 48', 'description': 'The mMCS is a tool designed to measure disease activity for ulcerative colitis. The mMCS was calculated as the sum of the 3 subscores: stool frequency, rectal bleeding, and endoscopy. Each subscore was graded from 0 to 3 with higher scores indicating more severe disease activity. The total mMCS score ranged from 0 to 9 with higher scores indicating more severe disease activity.\n\nThe mMCS remission was defined as a total score of score ≤2, with endoscopic subscore of ≤1, stool frequency subscore of ≤1, and a rectal bleeding subscore of 0.\n\nCorticosteroid-free mMCS remission was defined as being free of corticosteroids for at least 12 weeks.'}], 'secondaryOutcomes': [{'measure': 'Time to Patient-Reported Outcome Based on 2 Items (PRO2) Flare', 'timeFrame': 'Baseline up to Week 48', 'description': 'PRO2 flare was defined as a PRO2 score worsening of at least 2 points and an absolute PRO2 score of at least 3, with stool frequency subscore ≥2, and rectal bleeding subscore ≥1.\n\nPRO2 included items of stool frequency and rectal bleeding. The range of each item score was 0 to 3 with higher scores indicating more severe disease.'}, {'measure': 'Time to ES-Confirmed UC Flare', 'timeFrame': 'Baseline up to Week 48', 'description': 'An ES-confirmed UC flare was defined as an increase in rectal bleeding subscore by at least 1 point and an increase in stool frequency subscore by at least 2 points and an increase in endoscopic subscore by at least 1 point. Each subscore graded from 0 to 3 with higher scores indicating more severe disease.'}, {'measure': 'Change From Baseline in C-Reactive Protein (CRP)', 'timeFrame': 'Baseline, Week 4, Week 12, Week 24, Week 36, and Week 48', 'description': 'CRP is an acute-phase protein which provides an objective criterion of inflammatory activity.'}, {'measure': 'Change From Baseline in Fecal Calprotectin (FCP)', 'timeFrame': 'Baseline, Week 4, Week 12, Week 24, Week 36, and Week 48', 'description': 'Fecal calprotectin, a very stable biomarker, was a 36 kilodalton calcium and zinc binding protein of S-100 protein family which was neutrophil derived. It represents 60% of cytosolic proteins in neutrophils and was a measurement of neutrophil migration to the gastrointestinal tract.'}, {'measure': 'Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Score', 'timeFrame': 'Baseline, Week 48', 'description': 'The IBDQ is disease-specific questionnaire used for an assessment of Health Related Quality of Life (HRQoL) in participants with the Inflammatory Bowel Disease (IBD). It comprised of 32 questions divided into four health subscales: bowel symptoms (10 questions); systemic symptoms, including sleep disorders and fatigue (5 questions); emotional function such as depression, aggression, and irritation (12 questions); and social function, meaning the ability to participate in social activities and to work (5 questions). The IBDQ total score was calculated as the sum of the responses (each ranging from 1 \\[severe problem\\] to 7 \\[normal health\\]) to all 32 questions. Total IBDQ score ranged from 32 to 224 with a higher score indicating a better HRQoL.'}, {'measure': 'Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (SAEs), and TEAEs Leading to Treatment Discontinuation', 'timeFrame': 'Baseline up to Week 48', 'description': 'An adverse event (AE) was any untoward medical occurrence, new or worsening of any preexisting condition, in a clinical study participant administered a medicinal product and which did not necessarily had to have a causal relationship with this treatment.\n\nA TEAE was defined as\n\n* An AE which had a start date equal to or after the date of the first administration of study drug in this study and no later than 30 days after last administration of study drug.\n* And was either a newly reported event, or a worsening of an existing event.\n\nSerious TEAE was defined as a TEAE that\n\n* Resulted in death and was life-threatening;\n* Required in-patient hospitalization or prolongation of existing hospitalization;\n* Resulted in persistent or significant disability/incapacity;\n* Was a congenital anomaly / birth defect;\n* Was medically significant.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ulcerative Colitis']}, 'descriptionModule': {'briefSummary': 'Participants who were in clinical remission on 200 milligram (mg) filgotinib once daily for at least 2 consecutive quarterly visits in the ongoing SELECTION-LTE study (GS-US-418-3899, NCT02914535), were planned to be rolled over and randomized in this study. The primary objective of this study was to evaluate the efficacy of filgotinib in participants in stable clinical remission on 200 mg filgotinib once daily for whom the dose was decreased to 100 mg once daily compared to participants remaining on 200 mg once daily.', 'detailedDescription': 'Participants were planned to receive the blinded treatment until primary analysis time point. After unblinding at the study primary analysis time point, participants would have received unblinded treatment. The clinical trial was originally designed with the primary endpoint to be assessed at Week 48. Due to early termination of the study, none of the participants completed 48 weeks of treatment. All participants participated in blinded treatment period only and the study was unblinded globally after study completion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Participants must have participated in the SELECTION-LTE study (GS-US-418-3899), who were on 200 mg filgotinib once daily and fulfilled the following conditions:\n\n * partial Mayo Clinical Score remission over a period of at least 2 consecutive quarterly visits in the SELECTION-LTE study (GS-US-418-3899) prior to screening of the present study;\n * free of corticosteroids for at least 12 weeks prior to and including baseline;\n * fecal calprotectin (FCP) ≤250 microgram per gram (μg/g) at last observation within 6 months prior to screening or FCP ≤250 μg/g during the screening of the present study.\n * sigmoidoscopy ES of 0 or 1 (local score) at screening.\n* Willing to refrain from live attenuated vaccines during the study and for 12 weeks after the last dose of filgotinib in the study.\n* Female participants of childbearing potential must have had a negative highly sensitive (serum beta human chorionic gonadotropin) pregnancy test during screening and must have agreed to continued monthly urine dipstick pregnancy testing during filgotinib treatment.\n* Female participants of childbearing potential must have agreed to use highly effective contraception measures as defined in the protocol.\n\nKey Exclusion Criteria:\n\n* Any chronic medical condition (including but not limited to, cardiac or pulmonary disease, alcohol, or drug abuse) that, in the opinion of the investigator or sponsor, would make the participant unsuitable for the study or would prevent compliance with the study protocol.\n* Participant had a known hypersensitivity to filgotinib ingredients or history of a significant allergic reaction to filgotinib ingredients as determined by the investigator.\n* Female participant who was pregnant or breastfeeding, or intended to become pregnant or breastfeed, and/or plans to undergo egg donation or egg harvesting for the purpose of current or future fertilization, during the study and until the end of the study.\n* Participant was unable or unwilling to comply with restrictions regarding prior and concomitant medication as described in the protocol.\n* Participant had a positive QuantiFERON® tuberculosis (TB) test at screening or had 2 indeterminate QuantiFERON® TB test results that required Investigational product (IP) treatment interruption, or participant had sign and symptoms of TB reactivation at screening.\n* History of malignancy during or in the last 5 years prior to participation in the UC parent studies, except for participants who had been successfully treated for nonmelanoma skin cancer or cervical carcinoma in situ.\n* Participant met discontinuation criteria of the SELECTION-LTE study (GS-US-418-3899).\n\nNOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT05479058', 'acronym': 'CAPYBARA', 'briefTitle': 'A Study Evaluating the Effect of Filgotinib Dose De-escalation in Participants With Ulcerative Colitis (UC) in Remission', 'organization': {'class': 'INDUSTRY', 'fullName': 'Galapagos NV'}, 'officialTitle': 'A Randomized, Double-blind, Controlled, Multi-center Study to Evaluate the Efficacy and Safety of Dose De-escalation of Orally Administered Filgotinib in Subjects With Ulcerative Colitis in Clinical Remission', 'orgStudyIdInfo': {'id': 'GLPG0634-CL-341'}, 'secondaryIdInfos': [{'id': '2022-000719-30', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Filgotinib 200 mg', 'description': 'Participants received filgotinib 200 mg and placebo to match filgotinib 100 mg once daily orally.', 'interventionNames': ['Drug: Filgotinib', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Filgotinib 100 mg', 'description': 'Participants received filgotinib 100 mg and placebo to match filgotinib 200 mg once daily orally.', 'interventionNames': ['Drug: Filgotinib', 'Drug: Placebo']}], 'interventions': [{'name': 'Filgotinib', 'type': 'DRUG', 'otherNames': ['GS-6034', 'GLPG0634'], 'description': 'Administered orally once daily', 'armGroupLabels': ['Filgotinib 100 mg', 'Filgotinib 200 mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Administered orally once daily', 'armGroupLabels': ['Filgotinib 100 mg', 'Filgotinib 200 mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '34102', 'city': 'Naples', 'state': 'Florida', 'country': 'United States', 'facility': 'Gastroenterology Group of Naples', 'geoPoint': {'lat': 26.14234, 'lon': -81.79596}}, {'zip': '21045', 'city': 'Columbia', 'state': 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'Lüneburg', 'country': 'Germany', 'facility': 'Klinikum Lüneburg', 'geoPoint': {'lat': 53.2509, 'lon': 10.41409}}, {'zip': '32423', 'city': 'Minden', 'country': 'Germany', 'facility': 'Gastroenterologische Gemeinschaftspraxis Minden', 'geoPoint': {'lat': 52.28953, 'lon': 8.91455}}, {'zip': '1097', 'city': 'Budapest', 'country': 'Hungary', 'facility': 'Dél-pesti Centrumkórház - Országos Hematológiai és Infektológiai Intézet', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': '3200', 'city': 'Gyöngyös', 'country': 'Hungary', 'facility': 'Bugát Pál Kórház', 'geoPoint': {'lat': 47.78257, 'lon': 19.928}}, {'zip': '70013', 'city': 'Castellana Grotte', 'country': 'Italy', 'facility': 'IRCCS de Bellis Unità Operativa Complessa Gastroenterologia II', 'geoPoint': {'lat': 40.88643, 'lon': 17.16549}}, {'zip': '88100', 'city': 'Catanzaro', 'country': 'Italy', 'facility': 'Azienda Ospedaliero-Universitaria Mater Domini Unita Operativa Fisopatologia Digestiva', 'geoPoint': {'lat': 38.88247, 'lon': 16.60086}}, {'zip': '56124', 'city': 'Pisa', 'country': 'Italy', 'facility': 'Azienda Ospedaliero-Universitaria Pisana U.O. Gastroentrologia Stabilimento di Cisanello', 'geoPoint': {'lat': 43.70853, 'lon': 10.4036}}, {'zip': '20089', 'city': 'Rozzano', 'country': 'Italy', 'facility': 'Istituto di Ricovero e Cura a Carattere Scientifico - Istituto Clinico Humanitas', 'geoPoint': {'lat': 45.38193, 'lon': 9.1559}}, {'zip': '85-079', 'city': 'Bydgoszcz', 'country': 'Poland', 'facility': 'Przychodnia Vitamed NFZ', 'geoPoint': {'lat': 53.1235, 'lon': 18.00762}}, {'zip': '31-009', 'city': 'Krakow', 'country': 'Poland', 'facility': 'Gabinet Endoskopii Przewodu Pokarmowego', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'zip': '31-501', 'city': 'Krakow', 'country': 'Poland', 'facility': 'Krakowskie Centrum Medyczne', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'zip': '95-054', 'city': 'Ksawerów', 'country': 'Poland', 'facility': 'Centrum Opieki Zdrowotnej Orkan-Med', 'geoPoint': {'lat': 51.68288, 'lon': 19.4028}}, {'zip': '90-302', 'city': 'Lodz', 'country': 'Poland', 'facility': 'Santa Familia - Centrum Badań Profilaktyki i Leczenia', 'geoPoint': {'lat': 51.77058, 'lon': 19.47395}}, {'zip': '35-302', 'city': 'Rzeszów', 'country': 'Poland', 'facility': 'Gabinet Lekarski Dr. Hab. N. Med. Bartosz Korczowski', 'geoPoint': {'lat': 50.04132, 'lon': 21.99901}}, {'zip': '81-756', 'city': 'Sopot', 'country': 'Poland', 'facility': 'Endoskopia Sopot', 'geoPoint': {'lat': 54.4418, 'lon': 18.56003}}, {'zip': '87-100', 'city': 'Torun', 'country': 'Poland', 'facility': 'Torunskiego Centrum Gastrologii I Endoskopii - Gastromed', 'geoPoint': {'lat': 53.01375, 'lon': 18.59814}}, {'zip': '43-100', 'city': 'Tychy', 'country': 'Poland', 'facility': 'H-T. Centrum Medyczne Spółka z Ograniczoną Odpowiedzialnością', 'geoPoint': {'lat': 50.13717, 'lon': 18.96641}}, {'zip': '03-580', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'Niepubliczny Zakład Opieki Zdrowotnej VIVAMED Jadwiga Miecz', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '03-712', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'Bodyclinic', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '52-416', 'city': 'Wroclaw', 'country': 'Poland', 'facility': 'Centrum Medyczne Oporów', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}, {'zip': '7500', 'city': 'Cape Town', 'country': 'South Africa', 'facility': 'Mediclinic Panorama', 'geoPoint': {'lat': -33.92584, 'lon': 18.42322}}, {'zip': '42415', 'city': 'Daegu', 'country': 'South Korea', 'facility': 'Yeungnam University Medical Center', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'zip': '02447', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Kyung Hee University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '03181', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Kangbuk Samsung Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '03722', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Yonsei University Health System Severance Hospital Gastroenterology', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '41013', 'city': 'Seville', 'country': 'Spain', 'facility': 'Hospital Universitario Virgen del Rocío', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'zip': '10002', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'National Taiwan University Hospital Center for Infection Control', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'zip': 'CB2 0QQ', 'city': 'Cambridge', 'country': 'United Kingdom', 'facility': "Addenbrooke's Hospital", 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}, {'zip': 'NR4 YUY', 'city': 'Norwich', 'country': 'United Kingdom', 'facility': 'Norfolk and Norwich University Hospital', 'geoPoint': {'lat': 52.62783, 'lon': 1.29834}}, {'zip': 'L35 5DR', 'city': 'Prescot', 'country': 'United Kingdom', 'facility': 'Saint Helens and Knowsley Teaching Hospitals NHS Trust', 'geoPoint': {'lat': 53.42948, 'lon': -2.80031}}, {'zip': 'SO16 6YD', 'city': 'Southampton', 'country': 'United Kingdom', 'facility': 'University Hospital Southampton NHS Foundation Trust', 'geoPoint': {'lat': 50.90395, 'lon': -1.40428}}], 'overallOfficials': [{'name': 'Galapagos Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Galapagos NV'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Galapagos NV', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}