Ignite Creation Date:
2025-12-25 @ 4:33 AM
Ignite Modification Date:
2025-12-26 @ 3:35 AM
Study NCT ID:
NCT03368118
Status:
COMPLETED
Last Update Posted:
2025-05-29
First Post:
2017-11-13
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study Evaluating the Long-term Safety and Efficacy of ABX464 in Active Ulcerative Colitis
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': 'C000623073', 'term': 'ABX464'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'paul.gineste@abivax.com', 'phone': '01 53 83 08 41', 'title': 'Vice President Clinical Operations', 'organization': 'Abivax'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse event were collected from first day of dosing (baseline) up to last safety visit (up to 49 months : 48 months on treatment and one month safety follow-up)', 'eventGroups': [{'id': 'EG000', 'title': 'ABX464 Treatment Arm', 'description': 'All subjects received ABX464 at 50 mg o.d for an overall period of 48 months.\n\nABX464: All subjects received ABX464 given at 50 mg o.d for an overall period of 48 months.', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 20, 'seriousNumAtRisk': 22, 'deathsNumAffected': 0, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'colitis ulcerative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 11, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 10, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 9, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 7, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}], 'seriousEvents': [{'term': 'Myocardial infarction', 'notes': 'The event was considered not related to study treatment and resolved without sequelae 5 days after onset date. No action was taken with study treatment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'enteropathic spondylitis', 'notes': 'The subject admitted to hospital due to spondyloarthropathy caused by inflammatory bowel disease (HLA-B27+). The event considered not related to study treatment and resolved without sequelae. No action was taken with study treatment.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'benign ovarian tumor', 'notes': 'subject underwent total hysterectomy. Event considered not related to study treatment and resolved without sequelae. Study treatment was temporarily discontinued.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Treatment-emergent Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ABX464 Treatment Arm', 'description': 'All subjects received ABX464 at 50 mg o.d for an overall period of 48 months.\n\nABX464: All subjects received ABX464 given at 50 mg o.d for an overall period of 48 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '145', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Through subject study treatment, up to 48 months', 'description': 'Number of treatment-emergent adverse events in ABX464 treated subjects', 'unitOfMeasure': 'events', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Total Mayo Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ABX464 Treatment Arm', 'description': 'All subjects received ABX464 at 50 mg o.d for an overall period of 48 months.\n\nABX464: All subjects received ABX464 given at 50 mg o.d for an overall period of 48 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.0', 'spread': '3.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to Month 48', 'description': 'The change from Day 0 up to Month 48 in Total Mayo Score. total mayo score is an index and consists of 4 items: stool frequency, rectal bleeding, flexible sigmoidoscopic examination, and a physician global assessment of disease activity.\n\nEach parameter of the score ranges from zero (normal or inactive disease) to 3 (severe activity). The total mayo score scale ranging is from 0 to 12 The change from baseline of this score is part of the clinical response definition: to get a clinical response, a reduction in Total Mayo score of at least 2 points is required. A higher (in negative) change shows a better clinical response.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Non responder Imputation (NRI) population'}, {'type': 'SECONDARY', 'title': 'Partial Mayo Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ABX464 Treatment Arm', 'description': 'All subjects received ABX464 at 50 mg o.d for an overall period of 48 months.\n\nABX464: All subjects received ABX464 given at 50 mg o.d for an overall period of 48 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.2', 'spread': '2.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to Month 48', 'description': 'The change from Day 0 up to Month 48 in Partial Mayo Score; Partial Mayo score is an index and consists of 3 items: stool frequency, rectal bleeding and a physician global assessment of disease activity.\n\nEach parameter of the score ranges from zero (normal or inactive disease) to 3 (severe activity). The partial mayo score scale ranging is from 0 to 9.\n\nA higher (in negative) change from baseline shows a better clinical response', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Non responder imputation population'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Clinical Response at Month 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ABX464 Treatment Arm', 'description': 'All subjects received ABX464 at 50 mg o.d for an overall period of 48 months.\n\nABX464: All subjects received ABX464 given at 50 mg o.d for an overall period of 48 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 48 months', 'description': 'Clinical response was defined as:\n\nreduction in Total Mayo Score (TMS) of at least 2 points and \\>= 30 percent from baseline with an accompanying decrease in rectal bleeding sub-score of \\>= 1 point or absolute rectal bleeding sub-score of \\<= 1 point.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Non responder imputation population'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Clinical Remission at Month 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ABX464 Treatment Arm', 'description': 'All subjects received ABX464 at 50 mg o.d for an overall period of 48 months.\n\nABX464: All subjects received ABX464 given at 50 mg o.d for an overall period of 48 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 48 months', 'description': 'Clinical remission was achieved when all the following criteria were met in the components of the Mayo clinical Score:\n\nrectal bleeding sub-score = 0 central endoscopy sub-score \\<= 1 stool frequency sub-score \\<= 1', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'non responder imputation population'}, {'type': 'SECONDARY', 'title': 'Number of Subject With Endoscopic Improvement at Month 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ABX464 Treatment Arm', 'description': 'All subjects received ABX464 at 50 mg o.d for an overall period of 48 months.\n\nABX464: All subjects received ABX464 given at 50 mg o.d for an overall period of 48 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 48 Months', 'description': 'oEndoscopic improvement was achieved if the Mayo central endoscopic sub-score is 0 or 1.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Non responder imputation population'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Endoscopic Remission at Month 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ABX464 Treatment Arm', 'description': 'All subjects received ABX464 at 50 mg o.d for an overall period of 48 months.\n\nABX464: All subjects received ABX464 given at 50 mg o.d for an overall period of 48 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 48 months', 'description': 'Endoscopic remission was defined as Mayo central endoscopic sub-score = 0', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'non responder imputation population'}, {'type': 'SECONDARY', 'title': 'Fecal Calprotectin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ABX464 Treatment Arm', 'description': 'All subjects received ABX464 at 50 mg o.d for an overall period of 48 months.\n\nABX464: All subjects received ABX464 given at 50 mg o.d for an overall period of 48 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '-299.69', 'spread': '472.28', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to Month 48', 'description': 'The change from Day 0 up to Month 48 in fecal calprotectin A higher (in negative) change shows a better efficacy', 'unitOfMeasure': 'ug/g', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Non responder imputation population'}, {'type': 'SECONDARY', 'title': 'CRP Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ABX464 Treatment Arm', 'description': 'All subjects received ABX464 at 50 mg o.d for an overall period of 48 months.\n\nABX464: All subjects received ABX464 given at 50 mg o.d for an overall period of 48 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.29', 'spread': '4.82', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to Month 48', 'description': 'The change from Day 0 up to Month 48 in CRP levels', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Non responder imputation population'}, {'type': 'SECONDARY', 'title': 'Number of Treatment-emergent Serious Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ABX464 Treatment Arm', 'description': 'All subjects received ABX464 at 50 mg o.d for an overall period of 48 months.\n\nABX464: All subjects received ABX464 given at 50 mg o.d for an overall period of 48 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Through subject study treatment, up to 48 months', 'description': 'The number of incidences of treatment-emergent serious adverse events', 'unitOfMeasure': 'events', 'reportingStatus': 'POSTED', 'populationDescription': 'Observed cases population'}, {'type': 'SECONDARY', 'title': 'Number of Treatment-emergent Adverse Events of Special Interest', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ABX464 Treatment Arm', 'description': 'All subjects received ABX464 at 50 mg o.d for an overall period of 48 months.\n\nABX464: All subjects received ABX464 given at 50 mg o.d for an overall period of 48 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Through subject study treatment, up to 48 months', 'description': 'The number of incidences of treatment-emergent adverse events of special interest', 'unitOfMeasure': 'events', 'reportingStatus': 'POSTED', 'populationDescription': 'Observed cases population'}, {'type': 'SECONDARY', 'title': 'Number of Adverse Events Leading to Investigational Product Discontinuation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ABX464 Treatment Arm', 'description': 'All subjects received ABX464 at 50 mg o.d for an overall period of 48 months.\n\nABX464: All subjects received ABX464 given at 50 mg o.d for an overall period of 48 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Through subject study treatment, up to 48 months', 'description': 'The number of incidences of adverse events leading to investigational product discontinuation', 'unitOfMeasure': 'event', 'reportingStatus': 'POSTED', 'populationDescription': 'Observed cases population'}, {'type': 'SECONDARY', 'title': 'Number of Specific Laboratory Abnormalities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ABX464 Treatment Arm', 'description': 'All subjects received ABX464 at 50 mg o.d for an overall period of 48 months.\n\nABX464: All subjects received ABX464 given at 50 mg o.d for an overall period of 48 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Through first year of subject study treatment, 12 months', 'description': 'The number of incidences of specific laboratory abnormalities', 'unitOfMeasure': 'events', 'reportingStatus': 'POSTED', 'populationDescription': 'Observed Cases'}, {'type': 'SECONDARY', 'title': 'SF-36 Quality of Life Questionnaire (SF-36 Physical Component)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ABX464 Treatment Arm', 'description': 'All subjects received ABX464 at 50 mg o.d for an overall period of 48 months.\n\nABX464: All subjects received ABX464 given at 50 mg o.d for an overall period of 48 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.82', 'spread': '4.23', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 24 months', 'description': 'Change from Day 0 up to 24 months in SF-36 Questionnaire scores; The SF-36 questionnaire is a self-administered questionnaire containing 36 items.\n\nIt measures health on eight multi-item dimensions, covering functional status, well-being, and overall evaluation of health.\n\nThese items are grouped in 2 distincts components: a physical component (SF-36 physical) and a mental component (SF-36 mental).\n\nThis outcome describes the SF-36 physical component. Each item score ranging is from 0 to 100. A higher positive value in change indicate a better health status. The higher the change from baseline, the better improvement', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Non responder imputation population'}, {'type': 'SECONDARY', 'title': 'SF-36 Quality of Life Questionnaire (SF-36 Mental Component)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ABX464 Treatment Arm', 'description': 'All subjects received ABX464 at 50 mg o.d for an overall period of 48 months.\n\nABX464: All subjects received ABX464 given at 50 mg o.d for an overall period of 48 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.38', 'spread': '3.40', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 24 months', 'description': 'Change from Day 0 up to 24 months in SF-36 Questionnaire scores; The SF-36 questionnaire is a self-administered questionnaire containing 36 items.\n\nIt measures health on eight multi-item dimensions, covering functional status, well-being, and overall evaluation of health.\n\nThese items are grouped in 2 distincts components: a physical component (SF-36 physical) and a mental component (SF-36 mental).\n\nThis outcome describes the SF-36 mental component. Each item score ranging is from 0 to 100. A higher positive value in change indicate a better health status. The higher the change from baseline, the better improvement', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Non responder imputation population'}, {'type': 'SECONDARY', 'title': 'Erythrocyte Sedimentation Rate (ESR) Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ABX464 Treatment Arm', 'description': 'All subjects received ABX464 at 50 mg o.d for an overall period of 48 months.\n\nABX464: All subjects received ABX464 given at 50 mg o.d for an overall period of 48 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.90', 'spread': '8.62', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'up to 48 Months', 'description': 'The change from Day 0 up to Month 48 in ESR levels', 'unitOfMeasure': 'mm/hour', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Non responder imputation population'}, {'type': 'POST_HOC', 'title': 'UC Worsening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ABX464 Treatment Arm', 'description': 'All subjects received ABX464 at 50 mg o.d for an overall period of 48 months.\n\nABX464: All subjects received ABX464 given at 50 mg o.d for an overall period of 48 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Month 48', 'description': 'Proportion of subjects with UC worsening based on adverse events', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'ABX464 Treatment Arm', 'description': 'All subjects received ABX464 at 50 mg o.d for an overall period of 48 months.\n\nABX464: All subjects received ABX464 given at 50 mg o.d for an overall period of 48 months.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'ABX464 Treatment Arm', 'description': 'All subjects will receive ABX464 at 50 mg o.d for an overall period of 48 months.\n\nABX464: All subjects will receive ABX464 given at 50 mg o.d for an overall period of 48 months.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '42.4', 'spread': '14.3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '22', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Belgium', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}, {'title': 'Poland', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}, {'title': 'Hungary', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-02-07', 'size': 2501573, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-05-24T06:16', 'hasProtocol': True}, {'date': '2022-05-20', 'size': 1026907, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-05-24T06:17', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'open-label, follow-up study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2022-08-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-19', 'studyFirstSubmitDate': '2017-11-13', 'resultsFirstSubmitDate': '2023-05-24', 'studyFirstSubmitQcDate': '2017-12-05', 'lastUpdatePostDateStruct': {'date': '2025-05-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-02-28', 'studyFirstPostDateStruct': {'date': '2017-12-11', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Treatment-emergent Adverse Events', 'timeFrame': 'Through subject study treatment, up to 48 months', 'description': 'Number of treatment-emergent adverse events in ABX464 treated subjects'}], 'secondaryOutcomes': [{'measure': 'Total Mayo Score', 'timeFrame': 'Up to Month 48', 'description': 'The change from Day 0 up to Month 48 in Total Mayo Score. total mayo score is an index and consists of 4 items: stool frequency, rectal bleeding, flexible sigmoidoscopic examination, and a physician global assessment of disease activity.\n\nEach parameter of the score ranges from zero (normal or inactive disease) to 3 (severe activity). The total mayo score scale ranging is from 0 to 12 The change from baseline of this score is part of the clinical response definition: to get a clinical response, a reduction in Total Mayo score of at least 2 points is required. A higher (in negative) change shows a better clinical response.'}, {'measure': 'Partial Mayo Score', 'timeFrame': 'Up to Month 48', 'description': 'The change from Day 0 up to Month 48 in Partial Mayo Score; Partial Mayo score is an index and consists of 3 items: stool frequency, rectal bleeding and a physician global assessment of disease activity.\n\nEach parameter of the score ranges from zero (normal or inactive disease) to 3 (severe activity). The partial mayo score scale ranging is from 0 to 9.\n\nA higher (in negative) change from baseline shows a better clinical response'}, {'measure': 'Number of Subjects With Clinical Response at Month 48', 'timeFrame': 'up to 48 months', 'description': 'Clinical response was defined as:\n\nreduction in Total Mayo Score (TMS) of at least 2 points and \\>= 30 percent from baseline with an accompanying decrease in rectal bleeding sub-score of \\>= 1 point or absolute rectal bleeding sub-score of \\<= 1 point.'}, {'measure': 'Number of Subjects With Clinical Remission at Month 48', 'timeFrame': 'up to 48 months', 'description': 'Clinical remission was achieved when all the following criteria were met in the components of the Mayo clinical Score:\n\nrectal bleeding sub-score = 0 central endoscopy sub-score \\<= 1 stool frequency sub-score \\<= 1'}, {'measure': 'Number of Subject With Endoscopic Improvement at Month 48', 'timeFrame': 'up to 48 Months', 'description': 'oEndoscopic improvement was achieved if the Mayo central endoscopic sub-score is 0 or 1.'}, {'measure': 'Number of Subjects With Endoscopic Remission at Month 48', 'timeFrame': 'up to 48 months', 'description': 'Endoscopic remission was defined as Mayo central endoscopic sub-score = 0'}, {'measure': 'Fecal Calprotectin', 'timeFrame': 'Up to Month 48', 'description': 'The change from Day 0 up to Month 48 in fecal calprotectin A higher (in negative) change shows a better efficacy'}, {'measure': 'CRP Levels', 'timeFrame': 'Up to Month 48', 'description': 'The change from Day 0 up to Month 48 in CRP levels'}, {'measure': 'Number of Treatment-emergent Serious Adverse Events', 'timeFrame': 'Through subject study treatment, up to 48 months', 'description': 'The number of incidences of treatment-emergent serious adverse events'}, {'measure': 'Number of Treatment-emergent Adverse Events of Special Interest', 'timeFrame': 'Through subject study treatment, up to 48 months', 'description': 'The number of incidences of treatment-emergent adverse events of special interest'}, {'measure': 'Number of Adverse Events Leading to Investigational Product Discontinuation', 'timeFrame': 'Through subject study treatment, up to 48 months', 'description': 'The number of incidences of adverse events leading to investigational product discontinuation'}, {'measure': 'Number of Specific Laboratory Abnormalities', 'timeFrame': 'Through first year of subject study treatment, 12 months', 'description': 'The number of incidences of specific laboratory abnormalities'}, {'measure': 'SF-36 Quality of Life Questionnaire (SF-36 Physical Component)', 'timeFrame': 'Up to 24 months', 'description': 'Change from Day 0 up to 24 months in SF-36 Questionnaire scores; The SF-36 questionnaire is a self-administered questionnaire containing 36 items.\n\nIt measures health on eight multi-item dimensions, covering functional status, well-being, and overall evaluation of health.\n\nThese items are grouped in 2 distincts components: a physical component (SF-36 physical) and a mental component (SF-36 mental).\n\nThis outcome describes the SF-36 physical component. Each item score ranging is from 0 to 100. A higher positive value in change indicate a better health status. The higher the change from baseline, the better improvement'}, {'measure': 'SF-36 Quality of Life Questionnaire (SF-36 Mental Component)', 'timeFrame': 'Up to 24 months', 'description': 'Change from Day 0 up to 24 months in SF-36 Questionnaire scores; The SF-36 questionnaire is a self-administered questionnaire containing 36 items.\n\nIt measures health on eight multi-item dimensions, covering functional status, well-being, and overall evaluation of health.\n\nThese items are grouped in 2 distincts components: a physical component (SF-36 physical) and a mental component (SF-36 mental).\n\nThis outcome describes the SF-36 mental component. Each item score ranging is from 0 to 100. A higher positive value in change indicate a better health status. The higher the change from baseline, the better improvement'}, {'measure': 'Erythrocyte Sedimentation Rate (ESR) Levels', 'timeFrame': 'up to 48 Months', 'description': 'The change from Day 0 up to Month 48 in ESR levels'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ABX464', 'Ulcerative Colitis'], 'conditions': ['Ulcerative Colitis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.abivax.com/press-releases/', 'label': 'preliminary results at M24'}]}, 'descriptionModule': {'briefSummary': 'This study is an open-label study aiming at evaluating the long-term safety and the efficacy profile of ABX464 given once a day (o.d) at 50 mg in subjects who have been previously enrolled in the ABX464-101 clinical study (induction study) and who are willing to continue their treatment.', 'detailedDescription': "This study is an open-label study aiming at evaluating the long-term safety and the efficacy profile of ABX464 given once a day (o.d) at 50 mg in subjects who have been previously enrolled in the ABX464-101 clinical study (induction study) and who are willing to continue their treatment.\n\nAll subjects will receive ABX464 given at 50 mg o.d irrespective of their previous treatment received in the ABX464-101 study (i.e. ABX464 or Placebo).\n\nThe actual treatment received by a subject throughout the previous study (ABX464-101) will not be known at the time the subjects enter this follow-up study. This treatment group will be communicated (throughout the investigators) to the subjects at the end of the ABX464-101 study (planned in Q3/2018).\n\nThe enrolment in this follow-up study will be based on the willingness of the subject to carry on his/her participation and also based on investigator's judgement.\n\nSubjects will be treated with ABX464 for an overall period of 48 months. Subjects will be followed up weekly during the first month, every two weeks during the second month and then on a monthly basis until M24, then quaterly from M24 to M48."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nA subject will be eligible for inclusion in this study only if ALL of the following criteria apply:\n\n* Subjects previously enrolled in the ABX464-101 clinical study who have completed the initial 2-month treatment phase;\n* Subjects able and willing to comply with study visits and procedures;\n* Subjects with hematological and biochemical laboratory parameters as follows at the D56 visit of the ABX464-101 study:\n\n * Hemoglobin \\> 9.0 g dL-1;\n * Absolute neutrophil count ≥ 750 mm-3;\n * Platelets ≥ 100,000 mm-3;\n * Total serum creatinine ≤ 1.3 x ULN (upper limit of normal);\n * Creatinine clearance \\> 50 mL min-1 by the Cockcroft-Gault equation;\n * Total serum bilirubin \\< 1.5 x ULN;\n * Alkaline phosphatase, AST (SGOT) and ALT (SGPT) \\< 1.5 x ULN;\n* Subjects should understand, sign and date the written voluntary informed consent form at the enrolment visit prior to any protocol-specific procedures being performed;\n* Subjects should be affiliated to a social security regimen (for French sites only);\n* Females and males receiving the study treatment and their partners must agree to use a highly effective contraceptive method during the study and for 3 months after end of study or early termination. Contraception should be in place at least 3 months prior to study participation. Women must be either postmenopausal (at least 12 months of amenorrhea), surgically sterile or if of childbearing potential must use a highly effective contraceptive method. Women of childbearing potential (WOCBP) will enter the study after confirmed menstrual period and a negative pregnancy test. Highly effective methods of contraception include: true abstinence, intrauterine device (IUD), intrauterine hormone-releasing system (IUS), hormonal contraception (estrogen and progestogen or progestogen only) associated with inhibition of ovulation, bilateral tubal occlusion, vasectomized partner. True abstinence is defined when this is in line with the preferred and usual lifestyle of the subject. In each case of delayed menstrual period (over one month between menstruations) confirmation of absence of pregnancy is required. This recommendation also applies to WOCBP with infrequent or irregular menstrual cycle.\n\nExclusion Criteria:\n\nThe following criterion should be checked at the time of screening. If this exclusion criterion applies, the subject will not be included in the study:\n\n▪ Any condition, which in the opinion of the investigator, could compromise the subject's safety or the adherence to the study protocol."}, 'identificationModule': {'nctId': 'NCT03368118', 'briefTitle': 'Study Evaluating the Long-term Safety and Efficacy of ABX464 in Active Ulcerative Colitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abivax S.A.'}, 'officialTitle': 'A Follow-up Phase IIa Study to Evaluate the Long-term Safety and Efficacy Profile of ABX464 Given at 50 mg Once Daily in Subjects With Moderate to Severe Active Ulcerative Colitis.', 'orgStudyIdInfo': {'id': 'ABX464-102'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ABX464 Treatment arm', 'description': 'All subjects will receive ABX464 at 50 mg o.d for an overall period of 48 months.', 'interventionNames': ['Drug: ABX464']}], 'interventions': [{'name': 'ABX464', 'type': 'DRUG', 'description': 'All subjects will receive ABX464 given at 50 mg o.d for an overall period of 48 months.', 'armGroupLabels': ['ABX464 Treatment arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'Department of Gastroenterology - University hospitals Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}], 'overallOfficials': [{'name': 'Paul GINESTE', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Abivax S.A.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abivax S.A.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Orion Corporation, Orion Pharma', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}