Ignite Creation Date:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2026-02-21 @ 9:56 PM
Study NCT ID:
NCT03155932
Status:
TERMINATED
Last Update Posted:
2022-03-24
First Post:
2017-05-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety, Tolerability, and Efficacy of Etrasimod (APD334) in Participants With Primary Biliary Cholangitis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-02-23', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D008105', 'term': 'Liver Cirrhosis, Biliary'}], 'ancestors': [{'id': 'D002780', 'term': 'Cholestasis, Intrahepatic'}, {'id': 'D002779', 'term': 'Cholestasis'}, {'id': 'D001649', 'term': 'Bile Duct Diseases'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D008103', 'term': 'Liver Cirrhosis'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000656249', 'term': 'etrasimod'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ct.gov@arenapharm.com', 'phone': '+1 855-218-9153', 'title': 'Arena CT.gov Administrator', 'organization': 'Arena Pharmaceuticals, Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Up to Week 26', 'description': 'A TEAE was defined as any adverse events (AE) that were reported following study treatment administration and up to 2 weeks after the last treatment intake. An SAE was any untoward medical occurrence that at any dose resulted in the following outcomes: death, was life-threatening, required/prolonged hospitalization, disability/incapacity, congenital anomaly/birth defect, and important medical events.', 'eventGroups': [{'id': 'EG000', 'title': 'APD334', 'description': "Participants received APD334 1 mg tablet once daily (qd) by mouth for 12 weeks. The dose for APD334 was escalated to 2 mg at Week 12 to Week 24, based on the participant's safety and pharmacokinetic (PK) data.", 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 2, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Skin rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Worsening right hip pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Elevated gamma-glutamyl transferase-worsening', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Loose stools', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Common cold - Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Elevated alkaline phosphatase-worsening', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Lower abdominal cramps', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Cognitive defects', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Olecranon bursitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Serum Alkaline Phosphatase (ALP) Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'APD334', 'description': "Participants received APD334 1 mg tablet once daily (qd) by mouth for 12 weeks. The dose for APD334 was escalated to 2 mg at Week 12 to Week 24, based on the participant's safety and pharmacokinetic (PK) data."}], 'timeFrame': 'Baseline, Week 24', 'description': 'Reduction in ALP concentration is a surrogate marker of slower disease progression.', 'reportingStatus': 'POSTED', 'populationDescription': "Analyses were not conducted due to low enrollment (N=2). In order to protect participant's privacy, the results from the enrolled participants cannot be reported."}, {'type': 'PRIMARY', 'title': 'Number of Participants With Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'APD334', 'description': "Participants received APD334 1 mg tablet qd by mouth for 12 weeks. The dose for APD334 was escalated to 2 mg at Week 12 to Week 24, based on the participant's safety and PK data."}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Week 26', 'description': 'Safety was assessed by monitoring adverse events and clinically relevant changes in vital signs and clinical laboratory results.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Two participants who were enrolled and received treatment in this study.'}, {'type': 'SECONDARY', 'title': 'Change in Serum ALP Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'APD334', 'description': "Participants received APD334 1 mg tablet qd by mouth for 12 weeks. The dose for APD334 was escalated to 2 mg at Week 12 to Week 24, based on the participant's safety and PK data."}], 'timeFrame': 'Baseline, Week 12', 'description': 'Reduction in ALP concentration is a surrogate marker of slower disease progression.', 'reportingStatus': 'POSTED', 'populationDescription': "Analyses were not conducted due to low enrollment (N=2). In order to protect participant's privacy, the results from the enrolled participants cannot be reported."}, {'type': 'SECONDARY', 'title': 'Pharmacokinetic Parameters of Etrasimod, and Its Metabolites', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'APD334', 'description': "Participants received APD334 1 mg tablet qd by mouth for 12 weeks. The dose for APD334 was escalated to 2 mg at Week 12 to Week 24, based on the participant's safety and PK data."}], 'timeFrame': 'Up to Week 24', 'reportingStatus': 'POSTED', 'populationDescription': "Analyses were not conducted due to low enrollment (N=2). In order to protect participant's privacy, the results from the enrolled participants cannot be reported."}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Exploratory - Change in Complete Blood Count', 'timeFrame': 'Baseline, Week 12, Week 24', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Exploratory - Change in Incidence of Fatigue as Assessed by Peripheral Biliary Cholangitis (PBC-40) Scale', 'timeFrame': 'Baseline, Week 12, Week 24', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Exploratory - Change in Incidence of Pruritus as Assessed by 5-Dimensions (5-D) Itch Scale', 'timeFrame': 'Baseline, Week 12, Week 24', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Exploratory - Change in Schirmer Test Outcome', 'timeFrame': 'Baseline, Week 12, Week 24', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Exploratory - Change in Tear Film Break-Up Time', 'timeFrame': 'Baseline, Week 12, Week 24', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Exploratory - Change in Concentration of Serum High Sensitivity C-Reactive Protein (hsCRP)', 'timeFrame': 'Baseline, Week 12, Week 24', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Exploratory - Change in Concentration of Serum Alanine Transaminase (ALT)', 'timeFrame': 'Baseline, Week 12, Week 24', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Exploratory - Change in Concentration of Serum Aspartate Transaminase (AST)', 'timeFrame': 'Baseline, Week 12, Week 24', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Exploratory - Change in Concentration of Serum Gamma-Glutamyl Transferase (GGT)', 'timeFrame': 'Baseline, Week 12, Week 24', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Exploratory - Change in Concentration of Serum C4', 'timeFrame': 'Baseline, Week 12, Week 24', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Exploratory - Change in Concentration of Serum Immunoglobulin', 'timeFrame': 'Baseline, Week 12, Week 24', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Exploratory - Change in Concentration of Serum GP73', 'timeFrame': 'Baseline, Week 12, Week 24', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Exploratory - Change in Concentration of Serum Anti-Mitochondrial Antibodies (AMA)', 'timeFrame': 'Baseline, Week 12, Week 24', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Exploratory - Change in Quality of Life', 'timeFrame': 'Baseline, Week 12, Week 24', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'APD334', 'description': "Participants received APD334 1 mg tablet once daily (qd) by mouth for 12 weeks. The dose for APD334 was escalated to 2 mg at Week 12 to Week 24, based on the participant's safety and pharmacokinetic (PK) data."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Participants Escalated to 2 mg Dose of APD334 at Week 12 to Week 24', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Enrollment was planned for up to 20 participants. Two participants were enrolled into the study and completed 24 weeks of treatment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'APD334', 'description': "Participants received APD334 1 mg tablet once daily (qd) by mouth for 12 weeks. The dose for APD334 was escalated to 2 mg at Week 12 to Week 24, based on the participant's safety and pharmacokinetic (PK) data."}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': 'NA', 'comment': "Reporting demographic results for this study in which only two participants were enrolled introduces the risk of participant identification. In order to protect the participant's privacy, results for the study cannot be reported.", 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': 'NA', 'comment': "Reporting demographic results for this study in which only two participants were enrolled introduces the risk of participant identification. In order to protect the participant's privacy, results for the study cannot be reported.", 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': 'NA', 'comment': "Reporting demographic results for this study in which only two participants were enrolled introduces the risk of participant identification. In order to protect the participant's privacy, results for the study cannot be reported.", 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': 'NA', 'comment': "Reporting demographic results for this study in which only two participants were enrolled introduces the risk of participant identification. In order to protect the participant's privacy, results for the study cannot be reported.", 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': 'NA', 'comment': "Reporting demographic results for this study in which only two participants were enrolled introduces the risk of participant identification. In order to protect the participant's privacy, results for the study cannot be reported.", 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': 'NA', 'comment': "Reporting demographic results for this study in which only two participants were enrolled introduces the risk of participant identification. In order to protect the participant's privacy, results for the study cannot be reported.", 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': 'NA', 'comment': "Reporting demographic results for this study in which only two participants were enrolled introduces the risk of participant identification. In order to protect the participant's privacy, results for the study cannot be reported.", 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': 'NA', 'comment': "Reporting demographic results for this study in which only two participants were enrolled introduces the risk of participant identification. In order to protect the participant's privacy, results for the study cannot be reported.", 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': 'NA', 'comment': "Reporting demographic results for this study in which only two participants were enrolled introduces the risk of participant identification. In order to protect the participant's privacy, results for the study cannot be reported.", 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-06-27', 'size': 4363604, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-02-25T04:50', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Open label'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'whyStopped': 'Sponsor decision', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-12-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'dispFirstSubmitDate': '2020-01-30', 'completionDateStruct': {'date': '2019-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-28', 'studyFirstSubmitDate': '2017-05-11', 'dispFirstSubmitQcDate': '2022-02-28', 'resultsFirstSubmitDate': '2022-01-28', 'studyFirstSubmitQcDate': '2017-05-15', 'dispFirstPostDateStruct': {'date': '2022-03-24', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2022-03-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-02-28', 'studyFirstPostDateStruct': {'date': '2017-05-16', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-03-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Exploratory - Change in Complete Blood Count', 'timeFrame': 'Baseline, Week 12, Week 24'}, {'measure': 'Exploratory - Change in Incidence of Fatigue as Assessed by Peripheral Biliary Cholangitis (PBC-40) Scale', 'timeFrame': 'Baseline, Week 12, Week 24'}, {'measure': 'Exploratory - Change in Incidence of Pruritus as Assessed by 5-Dimensions (5-D) Itch Scale', 'timeFrame': 'Baseline, Week 12, Week 24'}, {'measure': 'Exploratory - Change in Schirmer Test Outcome', 'timeFrame': 'Baseline, Week 12, Week 24'}, {'measure': 'Exploratory - Change in Tear Film Break-Up Time', 'timeFrame': 'Baseline, Week 12, Week 24'}, {'measure': 'Exploratory - Change in Concentration of Serum High Sensitivity C-Reactive Protein (hsCRP)', 'timeFrame': 'Baseline, Week 12, Week 24'}, {'measure': 'Exploratory - Change in Concentration of Serum Alanine Transaminase (ALT)', 'timeFrame': 'Baseline, Week 12, Week 24'}, {'measure': 'Exploratory - Change in Concentration of Serum Aspartate Transaminase (AST)', 'timeFrame': 'Baseline, Week 12, Week 24'}, {'measure': 'Exploratory - Change in Concentration of Serum Gamma-Glutamyl Transferase (GGT)', 'timeFrame': 'Baseline, Week 12, Week 24'}, {'measure': 'Exploratory - Change in Concentration of Serum C4', 'timeFrame': 'Baseline, Week 12, Week 24'}, {'measure': 'Exploratory - Change in Concentration of Serum Immunoglobulin', 'timeFrame': 'Baseline, Week 12, Week 24'}, {'measure': 'Exploratory - Change in Concentration of Serum GP73', 'timeFrame': 'Baseline, Week 12, Week 24'}, {'measure': 'Exploratory - Change in Concentration of Serum Anti-Mitochondrial Antibodies (AMA)', 'timeFrame': 'Baseline, Week 12, Week 24'}, {'measure': 'Exploratory - Change in Quality of Life', 'timeFrame': 'Baseline, Week 12, Week 24'}], 'primaryOutcomes': [{'measure': 'Change in Serum Alkaline Phosphatase (ALP) Concentration', 'timeFrame': 'Baseline, Week 24', 'description': 'Reduction in ALP concentration is a surrogate marker of slower disease progression.'}, {'measure': 'Number of Participants With Adverse Events', 'timeFrame': 'Up to Week 26', 'description': 'Safety was assessed by monitoring adverse events and clinically relevant changes in vital signs and clinical laboratory results.'}], 'secondaryOutcomes': [{'measure': 'Change in Serum ALP Concentration', 'timeFrame': 'Baseline, Week 12', 'description': 'Reduction in ALP concentration is a surrogate marker of slower disease progression.'}, {'measure': 'Pharmacokinetic Parameters of Etrasimod, and Its Metabolites', 'timeFrame': 'Up to Week 24'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Primary Biliary Cholangitis']}, 'descriptionModule': {'briefSummary': 'The purpose of this open-label, pilot, proof of concept study is to evaluate the safety, tolerability, and efficacy of oral etrasimod (APD334) in participants with primary biliary cholangitis (PBC).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Key Inclusion Criteria:\n\n* Males or females aged 18 to 80 years (inclusive) at the time of screening, with confirmed Primary Biliary Cholangitis (PBC) diagnosis based upon at least 2 of 3 criteria:\n\n * Anti-mitochondrial antibodies (AMA) titer \\>1:40 on immunofluorescence or M2 positive by enzyme-linked immunosorbent assay (ELISA) or positive PBC-specific antinuclear antibodies (anti-GP210 and/or anti-SP100)\n * Alkaline phosphatase (ALP) \\>1.5 x upper limit of normal (ULN) for at least 6 months\n * Liver biopsy findings consistent with PBC\n* Use of ursodeoxycholic acid (UDCA) for at least 6 months prior to screening (stable dose for at least 3 months immediately prior to screening)\n* Participants must have ALP \\>1.5 x ULN but \\<10 x ULN, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \\<5 x ULN, and total bilirubin \\<ULN, at all screening visits\n* AST, ALT, ALP, and total bilirubin must have 2 values at least 4 weeks apart that are within 20% of each other\n\nKey Exclusion Criteria:\n\n* Chronic liver disease of a non-PBC etiology. However, PBC participants accompanied with primary Sjögren's syndrome (pSS) are eligible to be enrolled.\n* History or evidence of clinically significant hepatic decompensation\n* Medical conditions that may cause non-hepatic increases in ALP (e.g., Paget's disease)\n* Clinically significant infections within 6 weeks prior to treatment start, or infection with hepatitis C virus anytime in the past\n* Immunosuppressive, immunomodulating, or investigational agents within 30 days prior to treatment start\n* Treatment with obeticholic acid (OCA) within 30 days prior to Day 1\n\nNote: Other protocol defined Inclusion/Exclusion criteria may apply"}, 'identificationModule': {'nctId': 'NCT03155932', 'briefTitle': 'Safety, Tolerability, and Efficacy of Etrasimod (APD334) in Participants With Primary Biliary Cholangitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Arena Pharmaceuticals'}, 'officialTitle': 'An Open-label, Pilot, Proof of Concept Study to Evaluate the Safety, Tolerability, and Efficacy of Oral Etrasimod (APD334) in Patients With Primary Biliary Cholangitis', 'orgStudyIdInfo': {'id': 'APD334-010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'APD334', 'description': 'APD334 active treatment for 24 weeks.', 'interventionNames': ['Drug: APD334']}], 'interventions': [{'name': 'APD334', 'type': 'DRUG', 'otherNames': ['etrasimod'], 'description': 'APD334 active treatment for 24 weeks.', 'armGroupLabels': ['APD334']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Gastroenterology and Hepatology, UC Davis Medical Center', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor College of Medicine', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78215', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Liver Institute', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '98104', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Swedish Medical Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '2050', 'city': 'Camperdown', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Royal Prince Alfred Hospital', 'geoPoint': {'lat': -33.88965, 'lon': 151.17642}}, {'zip': '4575', 'city': 'Birtinya', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Sunshine Coast University Hospital', 'geoPoint': {'lat': -26.74322, 'lon': 153.11913}}, {'zip': '3004', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Alfred Health', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'zip': '1023', 'city': 'Grafton', 'state': 'Auckland', 'country': 'New Zealand', 'facility': 'Auckland City Hospital', 'geoPoint': {'lat': -36.86029, 'lon': 174.76566}}, {'zip': '8011', 'city': 'Christchurch', 'country': 'New Zealand', 'facility': 'Christchurch Clinical Studies Trust', 'geoPoint': {'lat': -43.53333, 'lon': 172.63333}}], 'overallOfficials': [{'name': 'Arena CT.gov Administrator', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Arena Pharmaceuticals'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Arena Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}