Ignite Creation Date:
2025-12-24 @ 10:06 PM
Ignite Modification Date:
2026-02-25 @ 5:42 PM
Study NCT ID:
NCT02914535
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-02-06
First Post:
2016-09-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Filgotinib in Long-Term Extension Study of Adults With Ulcerative Colitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Iceland']}, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Only 3 arms are blinded in this study.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1173}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2017-02-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-05', 'studyFirstSubmitDate': '2016-09-22', 'studyFirstSubmitQcDate': '2016-09-22', 'lastUpdatePostDateStruct': {'date': '2025-02-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Safety Profile of Filgotinib Evaluated by Proportion of Participants Experiencing Adverse Events and Abnormal Clinical Laboratory Tests', 'timeFrame': 'Up to 336 weeks plus 30 days'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Components of Mayo Clinic Score (MCS)', 'timeFrame': 'Baseline and up to 336 weeks'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ulcerative Colitis']}, 'referencesModule': {'references': [{'pmid': '39086130', 'type': 'DERIVED', 'citation': 'Feagan BG, Matsuoka K, Rogler G, Laharie D, Vermeire S, Danese S, Loftus EV Jr, Beales I, Schreiber S, Kim HJ, Faes M, de Haas A, Masior T, Rudolph C, Peyrin-Biroulet L. Long-term safety and efficacy of filgotinib for the treatment of moderately to severely active ulcerative colitis: Interim analysis from up to 4 years of follow-up in the SELECTION open-label long-term extension study. Aliment Pharmacol Ther. 2024 Sep;60(5):563-584. doi: 10.1111/apt.18158. Epub 2024 Jul 31.'}, {'pmid': '37718932', 'type': 'DERIVED', 'citation': 'Schreiber S, Rogler G, Watanabe M, Vermeire S, Maaser C, Danese S, Faes M, Van Hoek P, Hsieh J, Moerch U, Zhou Y, de Haas A, Rudolph C, Oortwijn A, Loftus EV Jr. Integrated safety analysis of filgotinib for ulcerative colitis: Results from SELECTION and SELECTIONLTE. Aliment Pharmacol Ther. 2023 Nov;58(9):874-887. doi: 10.1111/apt.17674. Epub 2023 Sep 18.'}, {'pmid': '37540206', 'type': 'DERIVED', 'citation': 'Vermeire S, Feagan BG, Peyrin-Biroulet L, Oortwijn A, Faes M, de Haas A, Rogler G. Withdrawal and Re-treatment with Filgotinib in Ulcerative Colitis: Post Hoc Analyses of the Phase 2b/3 SELECTION and SELECTIONLTE Studies. J Crohns Colitis. 2024 Jan 27;18(1):54-64. doi: 10.1093/ecco-jcc/jjad123.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to observe the long-term safety of filgotinib in adults who have completed or met protocol specified efficacy discontinuation criteria in a prior filgotinib treatment study in ulcerative colitis (UC).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Must have the ability to understand and sign a written informed consent form (ICF), which must be obtained prior to initiation of study procedures associated with this trial\n* Must have enrolled in Gilead-sponsored UC parent protocol GS US 418-3898 or any other Gilead/Galapagos-sponsored filgotinib treatment study for UC\n* Must have completed all required procedures or met protocol-specified efficacy discontinuation criteria in a prior filgotinib treatment study for UC\n* Females of childbearing potential must have a negative pregnancy test at Day 1\n* Female individuals of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception for the duration described\n* Willingness to refrain from live or attenuated vaccines during the study and for 12 weeks after last dose of study drug\n\nKey Exclusion Criteria:\n\n* Known hypersensitivity to the study drug\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 subject unsuitable for the study or would prevent compliance with the study protocol\n* Females of reproductive potential who are unwilling to abide by protocol-specified contraceptive methods as defined\n* Use of prohibited medications as outlined in the protocol\n\nNOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT02914535', 'acronym': 'SELECTIONLTE', 'briefTitle': 'Filgotinib in Long-Term Extension Study of Adults With Ulcerative Colitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alfasigma S.p.A.'}, 'officialTitle': 'A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects With Ulcerative Colitis', 'orgStudyIdInfo': {'id': 'GS-US-418-3899'}, 'secondaryIdInfos': [{'id': '2016-002765-58', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Filgotinib 200 mg (blinded dosing)', 'description': 'Filgotinib 200 mg + placebo to match filgotinib 100 mg for up to 336 weeks', 'interventionNames': ['Drug: Filgotinib', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Filgotinib 100 mg (blinded dosing)', 'description': 'Filgotinib 100 mg + placebo to match filgotinib 200 mg for up to 336 weeks', 'interventionNames': ['Drug: Filgotinib', 'Drug: Placebo']}, {'type': 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