Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2025-12-27 @ 10:55 PM
Study NCT ID:
NCT04577794
Status:
COMPLETED
Last Update Posted:
2023-01-27
First Post:
2020-09-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study Evaluating the Effects of GLPG3970 Given as an Oral Treatment for 6 Weeks in Adults With Ulcerative Colitis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003093', 'term': 'Colitis, Ulcerative'}, {'id': 'D003092', 'term': 'Colitis'}, {'id': 'D014456', 'term': 'Ulcer'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}], 'ancestors': [{'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'medicalinfo@glpg.com', 'phone': '+32 15 342 900', 'title': 'Galapagos Medical Information', 'organization': 'Galapagos NV'}, '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 Data from individual study centers in multicenter studies must not be published separately.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'First dose date up to 14 days after the last dose of study drug (up to 57 days)', 'description': 'Participants in the safety analysis set were analyzed.', 'eventGroups': [{'id': 'EG000', 'title': 'GLPG3970', 'description': 'Participants received 400 mg GLPG3970 oral solution, QD for a period of 6 weeks.', 'otherNumAtRisk': 21, 'deathsNumAtRisk': 21, 'otherNumAffected': 11, 'seriousNumAtRisk': 21, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Participants received GLPG3970 matching placebo oral solution, QD for a period of 6 weeks.', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 3, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Haematochezia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Frequent bowel movements', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Lipase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Amylase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Blood lactate dehydrogenase decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Lymphocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'SARS-CoV-2 test positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pelvic cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Total MCS at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GLPG3970', 'description': 'Participants received 400 mg GLPG3970 oral solution, QD for a period of 6 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received GLPG3970 matching placebo oral solution, QD for a period of 6 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.6', 'spread': '0.57', 'groupId': 'OG000'}, {'value': '-2.6', 'spread': '0.85', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.981', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least square (LS) mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.0', 'ciLowerLimit': '-1.7', 'ciUpperLimit': '1.7', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.02', 'groupDescription': 'An analysis of covariance (ANCOVA) was used with a multiple imputation method to handle missing values, with treatment as fixed effect and baseline score as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 6', 'description': "The MCS is the primary tool for assessing ulcerative colitis activity. Total MCS is the sum of 4 subscores (i.e., stool frequency, rectal bleeding, endoscopic findings, and a physician's global assessment); each rated on a scale from 0 (normal) to 3 (severe). The total MCS value ranges from 0 to 12, with higher scores indicating more severe disease. Missing data were imputed using Rubin's multiple imputation.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set consisted of all randomized participants who received at least 1 dose of IP. Participants with available data at specified timepoint were included.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment-Emergent Adverse Events (TEAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GLPG3970', 'description': 'Participants received 400 mg GLPG3970 oral solution, QD for a period of 6 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received GLPG3970 matching placebo oral solution, QD for a period of 6 weeks.'}], 'classes': [{'title': 'TEAEs', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Serious TEAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'TEAEs leading to death', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Treatment-related TEAEs', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'TEAEs leading to study drug discontinuation', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'First dose date up to 14 days after the last dose of study drug (up to 57 days)', 'description': 'Treatment-Emergent Adverse Events (TEAEs) were defined as\n\n* Any adverse event (AE) with an onset date on or after the IP start date and no later than 14 days after last dose of IP, or worsening of any AE on or after the IP start date.\n* Improvement or no change of any ongoing AEs on or after the IP start date are not considered treatment-emergent. If an AE was ongoing at the time of first IP intake and if there was no change or an improvement in its toxicity grade or its seriousness status, this AE was not considered as treatment-emergent.\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.', 'calculatePct': False, 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the safety analysis set were analyzed.'}, {'type': 'SECONDARY', 'title': 'Plasma Concentration (Ctrough) of GLPG3970', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GLPG3970', 'description': 'Participants received 400 mg GLPG3970 oral solution, QD for a period of 6 weeks.'}], 'classes': [{'title': 'Day 15: Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '73.2', 'spread': '145', 'groupId': 'OG000'}]}]}, {'title': 'Day 29: Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '55.9', 'spread': '65.3', 'groupId': 'OG000'}]}]}, {'title': 'Day 43: Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '84.9', 'spread': '107', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 15: pre-dose; Day 29: pre-dose; Day 43: pre-dose', 'description': 'Ctrough was defined as plasma concentration level at the end of the dosing interval.', 'unitOfMeasure': 'nanograms per milliliter (ng/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic analysis set consisted of all participants who received at least 1 dose of IP with available plasma concentration data. Participants with available plasma concentration at specified time point were included.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'GLPG3970', 'description': 'Participants received 400 milligrams (mg) GLPG3970 oral solution, once daily (QD) for a period of 6 weeks.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Participants received GLPG3970 matching placebo oral solution, QD for a period of 6 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Study was conducted across 4 countries (Georgia, the Republic of Moldova, Poland, and Ukraine).', 'preAssignmentDetails': 'A total of 65 participants were screened, out of which 31 were randomized and treated.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'GLPG3970', 'description': 'Participants received 400 mg GLPG3970 oral solution, QD for a period of 6 weeks.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Participants received GLPG3970 matching placebo oral solution, QD for a period of 6 weeks.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '39.7', 'spread': '10.9', 'groupId': 'BG000'}, {'value': '37.8', 'spread': '5.8', 'groupId': 'BG001'}, {'value': '39.1', 'spread': '9.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, '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': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', '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': '21', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '31', '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', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Total Mayo Clinical Score (MCS)', 'classes': [{'categories': [{'measurements': [{'value': '8.5', 'spread': '1.2', 'groupId': 'BG000'}, {'value': '8.2', 'spread': '1.3', 'groupId': 'BG001'}, {'value': '8.4', 'spread': '1.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "The MCS is the primary tool for assessing ulcerative colitis activity. Total MCS is the sum of 4 subscores (i.e., stool frequency, rectal bleeding, endoscopic findings, and a physician's global assessment); each rated on a scale from 0 (normal) to 3 (severe). The total MCS value ranges from 0 to 12, with higher scores indicating more severe disease.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Safety analysis set consisted of all participants who received at least 1 dose of investigational product (IP).'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-07-02', 'size': 6454867, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-04-26T07:49', 'hasProtocol': True}, {'date': '2021-06-16', 'size': 6906620, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-04-26T07:50', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2021-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-27', 'studyFirstSubmitDate': '2020-09-30', 'resultsFirstSubmitDate': '2022-04-27', 'studyFirstSubmitQcDate': '2020-09-30', 'lastUpdatePostDateStruct': {'date': '2023-01-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-04-27', 'studyFirstPostDateStruct': {'date': '2020-10-08', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-01-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Total MCS at Week 6', 'timeFrame': 'Baseline and Week 6', 'description': "The MCS is the primary tool for assessing ulcerative colitis activity. Total MCS is the sum of 4 subscores (i.e., stool frequency, rectal bleeding, endoscopic findings, and a physician's global assessment); each rated on a scale from 0 (normal) to 3 (severe). The total MCS value ranges from 0 to 12, with higher scores indicating more severe disease. Missing data were imputed using Rubin's multiple imputation."}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Treatment-Emergent Adverse Events (TEAEs)', 'timeFrame': 'First dose date up to 14 days after the last dose of study drug (up to 57 days)', 'description': 'Treatment-Emergent Adverse Events (TEAEs) were defined as\n\n* Any adverse event (AE) with an onset date on or after the IP start date and no later than 14 days after last dose of IP, or worsening of any AE on or after the IP start date.\n* Improvement or no change of any ongoing AEs on or after the IP start date are not considered treatment-emergent. If an AE was ongoing at the time of first IP intake and if there was no change or an improvement in its toxicity grade or its seriousness status, this AE was not considered as treatment-emergent.\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.'}, {'measure': 'Plasma Concentration (Ctrough) of GLPG3970', 'timeFrame': 'Day 15: pre-dose; Day 29: pre-dose; Day 43: pre-dose', 'description': 'Ctrough was defined as plasma concentration level at the end of the dosing interval.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Colitis', 'Ulcer', 'Moderately active ulcerative colitis', 'Chronic inflammatory bowel disease', 'Inflammatory Bowel Diseases', 'Digestive System Diseases'], 'conditions': ['Ulcerative Colitis']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study was to evaluate the effect of GLPG3970 compared to placebo on the signs and symptoms of Ulcerative Colitis (UC) in participants with moderately to severely active UC.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Key Inclusion Criteria:\n\n1. Documented diagnosis of UC of ≥3 months. The criteria for documentation of UC diagnosis based on endoscopy will be medical record documentation, and/or a colonoscopy report dated ≥3 months before screening, which shows features consistent with UC.\n2. Treatment-experienced participants with moderately to severely active disease, who have either previously demonstrated inadequate clinical response, loss of response, or intolerance to at least 1 course of standard-of-care (SoC) therapy for UC (i.e. steroids \\[oral or parenteral, including but not limited to prednisone, prednisolone, budesonide\\], 5-aminosalicylate \\[5- ASA\\] derivatives \\[including but not limited to mesalamine, sulfasalazine\\], anti-metabolites \\[including but not limited to azathioprine, 6 mercaptopurine, methotrexate\\], anti-tumor necrosis factor \\[TNF\\] agents, anti-integrins, Janus kinase \\[JAK\\] inhibitors), as confirmed by the investigator.\n3. Moderately to severely active UC as determined at screening by:\n\n 1. Centrally-read endoscopic evidence of disease activity (MCS- endoscopy subscore \\[ES\\] ≥2 OR ulcerative colitis endoscopic index of severity \\[UCEIS\\] ≥4) with a minimum disease extent of 15 cm from anal verge; AND\n 2. MCS stool frequency (SF) subscore ≥1; AND\n 3. MCS rectal bleeding (RB) subscore ≥1.\n4. Participants currently receiving the following SoC therapies for UC are eligible providing they have been on a stable dose for the designated period of time and are anticipated to be stable throughout the study:\n\n 1. oral corticosteroids (prednisone ≤20 mg/day or equivalent or budesonide ≤3 mg/day) stable dose for at least 2 weeks prior to first investigational product (IP) dosing.\n 2. oral 5-ASA compounds (mesalamine ≤4 grams \\[g\\]/day or sulfasalazine ≤4 g/day) stable dose for at least 4 weeks prior to first IP dosing.\n 3. oral thiopurines (azathioprine ≤2.5 mg/kg/day and 6-mercaptopurine 1.5 mg/kilograms \\[kg\\]/day) stable dose for at least 12 weeks prior to first IP dosing, or methotrexate ≤20 mg/week, stable dose for at least 12 weeks prior to first IP dosing.\n\nKey Exclusion Criteria:\n\n1. Diagnosis of Crohn's disease, indeterminate colitis, ischemic colitis, fulminant colitis, or toxic megacolon.\n2. Prior surgical intervention for UC (e.g. colectomy, partial colectomy, ileostomy or colostomy) or likely requirement for surgery for UC, during the study.\n3. History or evidence of incompletely resected colonic mucosal dysplasia.\n4. Exhibit acute severe UC per the following criteria:\n\n 1. bloody diarrhea ≥6/day AND\n 2. any of the following signs of systemic toxicity: Body temperature (oral or tympanic) ≥37.8 degrees celsius (°C) OR Resting pulse (after 5 min seated position) \\>90 beats per min OR hemoglobin \\<105 g/L, OR erythrocyte sedimentation rate \\>30 millimeters per hour (mm/h); OR C-reactive protein (CRP) \\>30 mg/L.\n5. Screening stool sample positive for ova and/or parasites, Clostridium difficile toxin, Escherichia coli, Salmonella species (spp), Shigella spp, Campylobacter spp or Yersinia spp.\n6. Participant testing positive at screening for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection as detected by real time polymerase chain reaction (RT-PCR), participants presenting any signs or symptoms as detected at baseline following careful physical examination (e.g. cough, fever, headaches, fatigue, dyspnea, myalgia, anosmia, dysgeusia, anorexia, sore throat, others) or reporting any signs and symptoms for the preceding 2 weeks, or participants who have been exposed to individuals with confirmed or suspected diagnosis of SARS-CoV-2 within 2 weeks prior to baseline. In addition, any other locally applicable standard diagnostic criteria may also apply to rule out SARS-CoV-2 infection.\n\nNote: Other protocol-defined Inclusion/Exclusion criteria may apply."}, 'identificationModule': {'nctId': 'NCT04577794', 'acronym': 'SEA TURTLE', 'briefTitle': 'A Study Evaluating the Effects of GLPG3970 Given as an Oral Treatment for 6 Weeks in Adults With Ulcerative Colitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Galapagos NV'}, 'officialTitle': 'A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety, Tolerability, Efficacy, and Pharmacokinetics of GLPG3970, Administered Orally for 6 Weeks in Adult Subjects With Moderately to Severely Active Ulcerative Colitis', 'orgStudyIdInfo': {'id': 'GLPG3970-CL-210'}, 'secondaryIdInfos': [{'id': '2020-000659-11', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GLPG3970', 'description': 'Participants received 400 milligrams (mg) GLPG3970 oral solution, once daily (QD) for a period of 6 weeks.', 'interventionNames': ['Drug: GLPG3970']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants received GLPG3970 matching placebo oral solution, QD for a period of 6 weeks.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'GLPG3970', 'type': 'DRUG', 'description': 'GLPG3970 powder and solvent for oral solution reconstituted prior to use.', 'armGroupLabels': ['GLPG3970']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo powder and solvent for oral solution reconstituted prior to use.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '0112', 'city': 'Tbilisi', 'country': 'Georgia', 'facility': 'Arensia Exploratory Medicine LLC', 'geoPoint': {'lat': 41.69143, 'lon': 44.83412}}, {'zip': '2025', 'city': 'Chisinau', 'country': 'Moldova', 'facility': 'ARENSIA Exploratory Medicine Phase I Unit', 'geoPoint': {'lat': 47.00902, 'lon': 28.85938}}, {'zip': '31-513', 'city': 'Krakow', 'country': 'Poland', 'facility': 'Centrum Medyczne PROMED', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'zip': '81-756', 'city': 'Sopot', 'country': 'Poland', 'facility': 'Endoskopia Sp. z o.o.', 'geoPoint': {'lat': 54.4418, 'lon': 18.56003}}, {'zip': '22-400', 'city': 'Zamość', 'country': 'Poland', 'facility': 'ETG Zamosc', 'geoPoint': {'lat': 50.72314, 'lon': 23.25196}}, {'zip': '49005', 'city': 'Dnipro', 'country': 'Ukraine', 'facility': 'I.I.Mechnykov Dnipropetrovsk Regional Clinical Hospital', 'geoPoint': {'lat': 48.46664, 'lon': 35.04066}}, {'zip': '76000', 'city': 'Ivano-Frankivsk', 'country': 'Ukraine', 'facility': 'Ivano-Frankivsk Regional Clinical Hospital', 'geoPoint': {'lat': 48.92312, 'lon': 24.71248}}, {'zip': '61037', 'city': 'Kharkiv', 'country': 'Ukraine', 'facility': 'CNE Prof. O.O. Shalimov Kharkiv City Clinical Hospital #2', 'geoPoint': {'lat': 49.98177, 'lon': 36.25475}}, {'zip': '61124', 'city': 'Kharkiv', 'country': 'Ukraine', 'facility': 'CHI Kharkiv City Clinical Hospital #13', 'geoPoint': {'lat': 49.98177, 'lon': 36.25475}}, {'zip': '73000', 'city': 'Kherson', 'country': 'Ukraine', 'facility': 'Communal Nonprofit Enterprise Kherson City Clinical Hospital n.a. Afanasii and Olga Tropini', 'geoPoint': {'lat': 46.63695, 'lon': 32.61458}}, {'zip': '01135', 'city': 'Kyiv', 'country': 'Ukraine', 'facility': 'Medical Center "Harmoniya Krasy"', 'geoPoint': {'lat': 50.45466, 'lon': 30.5238}}, {'zip': '02091', 'city': 'Kyiv', 'country': 'Ukraine', 'facility': "Med Center 'Ok!Clinic+' of International Institute of Clinical Trials LLC", 'geoPoint': {'lat': 50.45466, 'lon': 30.5238}}, {'zip': '21018', 'city': 'Vinnytsia', 'country': 'Ukraine', 'facility': 'M.I. Pyrogov VRCH Dept of Gastroenterology M.I. Pyrogov VNMU', 'geoPoint': {'lat': 49.2322, 'lon': 28.46871}}, {'zip': '21029', 'city': 'Vinnytsia', 'country': 'Ukraine', 'facility': 'CCH #1 Vinnytsia M.I. Pyrogov NMU Ch of Propaedeutics of IM', 'geoPoint': {'lat': 49.2322, 'lon': 28.46871}}, {'zip': '21029', 'city': 'Vinnytsia', 'country': 'Ukraine', 'facility': 'SRI of Invalid Rehabilitation (EST Complex) of Vinnytsia M.I.Pyrogov NMU MOHU', 'geoPoint': {'lat': 49.2322, 'lon': 28.46871}}], 'overallOfficials': [{'name': 'Galapagos Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Galapagos NV'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Galapagos NV', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}