Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2025-12-26 @ 4:13 AM
Study NCT ID:
NCT04950127
Status:
COMPLETED
Last Update Posted:
2025-07-22
First Post:
2021-06-25
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Global Linerixibat Itch Study of Efficacy and Safety in Primary Biliary Cholangitis (PBC) (GLISTEN)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Switzerland']}, 'conditionBrowseModule': {'meshes': [{'id': 'D011537', 'term': 'Pruritus'}, {'id': 'D002779', 'term': 'Cholestasis'}, {'id': 'D008105', 'term': 'Liver Cirrhosis, Biliary'}], 'ancestors': [{'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012877', 'term': 'Skin Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001649', 'term': 'Bile Duct Diseases'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D002780', 'term': 'Cholestasis, Intrahepatic'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D008103', 'term': 'Liver Cirrhosis'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'GSKClinicalSupportHD@gsk.com', 'phone': '866-435-7343', 'title': 'GSK Response Center', 'organization': 'GlaxoSmithKline'}, 'certainAgreement': {'otherDetails': 'GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call.', 'description': 'All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.', 'eventGroups': [{'id': 'EG000', 'title': 'Part A: Placebo', 'description': 'Participants were randomized to receive Placebo orally twice a day (BID) in Part A (up to Week 24).', 'otherNumAtRisk': 118, 'deathsNumAtRisk': 118, 'otherNumAffected': 54, 'seriousNumAtRisk': 118, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'Part A: Linerixibat 40 Milligrams (mg)', 'description': 'Participants were randomized to receive linerixibat 40 mg tablet orally twice a day (BID) in Part A (up to Week 24).', 'otherNumAtRisk': 119, 'deathsNumAtRisk': 119, 'otherNumAffected': 96, 'seriousNumAtRisk': 119, 'deathsNumAffected': 0, 'seriousNumAffected': 14}, {'id': 'EG002', 'title': 'Part B: Placebo in Part A and Part B', 'description': 'Participants who were randomized to receive Placebo (up to Week 24) orally twice a day (BID) in Part A, continued to receive Placebo (from Week 24 to Week 32) orally twice a day (BID) in Part B.', 'otherNumAtRisk': 53, 'deathsNumAtRisk': 53, 'otherNumAffected': 5, 'seriousNumAtRisk': 53, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Part B: Placebo in Part A and Linerixibat 40 mg in Part B', 'description': 'Participants who were randomized to receive Placebo (up to Week 24) orally twice a day (BID) in Part A, switched to receive linerixibat 40 mg tablet orally twice a day (BID) (from Week 24 to Week 32) in Part B.', 'otherNumAtRisk': 52, 'deathsNumAtRisk': 52, 'otherNumAffected': 16, 'seriousNumAtRisk': 52, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Part B: Linerixibat 40 mg in Part A and Placebo in Part B', 'description': 'Participants who were randomized to receive linerixibat 40 mg tablet orally BID (up to Week 24) in Part A, switched to receive Placebo (from Week 24 to Week 32) orally twice a day (BID) in Part B.', 'otherNumAtRisk': 46, 'deathsNumAtRisk': 46, 'otherNumAffected': 3, 'seriousNumAtRisk': 46, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG005', 'title': 'Part B: Linerixibat 40 mg in Part A and Part B', 'description': 'Participants who were randomized to receive linerixibat 40 mg tablet orally twice a day (BID) (up to Week 24) in Part A, continued to receive linerixibat 40 mg twice a day (BID) (from Week 24 to Week 32) in Part B.', 'otherNumAtRisk': 45, 'deathsNumAtRisk': 45, 'otherNumAffected': 7, 'seriousNumAtRisk': 45, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.1'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 10, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 27, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 14, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 28, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 112, 'numAffected': 72}, {'groupId': 'EG002', 'numAtRisk': 53, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 18, 'numAffected': 14}, {'groupId': 'EG004', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 45, 'numEvents': 12, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.1'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 9, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 13, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 13, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 17, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.1'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.1'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 9, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.1'}, {'term': 'Cholestatic pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 46, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.1'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.1'}, {'term': 'Haemorrhagic disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.1'}, {'term': 'Thrombocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.1'}, {'term': 'Sinus arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.1'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.1'}, {'term': 'Gastric haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.1'}, {'term': 'Gastric mucosal lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.1'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.1'}, {'term': 'Clostridium difficile colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.1'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.1'}, {'term': 'Blood pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.1'}, {'term': 'Diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.1'}, {'term': 'Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.1'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.1'}, {'term': 'Malignant melanoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.1'}, {'term': 'Renal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.1'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.1'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.1'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.1'}, {'term': 'Intermenstrual bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Part A: Mean Change From Baseline in Monthly Itch Scores Over 24 Weeks Using Numerical Rating Scale (NRS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Linerixibat 40 Milligrams (mg)', 'description': 'Participants were randomized to receive linerixibat 40 mg tablet orally twice a day (BID) in Part A (up to Week 24).'}, {'id': 'OG001', 'title': 'Part A: Placebo', 'description': 'Participants were randomized to receive Placebo orally twice a day (BID) in Part A (up to Week 24).'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.86', 'groupId': 'OG000', 'lowerLimit': '-3.23', 'upperLimit': '-2.50'}, {'value': '-2.15', 'groupId': 'OG001', 'lowerLimit': '-2.51', 'upperLimit': '-1.78'}]}]}], 'analyses': [{'pValue': '0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.72', 'ciLowerLimit': '-1.15', 'ciUpperLimit': '-0.28', 'groupDescription': 'The mixed model repeated measures analysis includes Treatment Group, Visit, Visit\\*Treatment Group interaction, Baseline Monthly Itch score (MIS), Visit\\*Baseline MIS interaction, Baseline Concomitant Itch Medication.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed Model Repeated Measures Analysis'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and up to Week 24', 'description': 'Itch Scores were assessed using a NRS twice daily, ranging from 0 to 10, where 0 represents no itching and 10 the worst imaginable itching. The worst daily itch score was defined as the worst of the two scores recorded daily. The weekly itch score was defined as the average of the worst daily itch scores in one week. The monthly itch score was defined as the worst weekly itch score for the month (4 weeks). Higher monthly itch scores indicate worse itching. Baseline is the worst weekly itch score in the 28 days prior to randomization (Day 1). Change from Baseline is defined as the post dose value minus baseline value. Least-squares (LS) means and the corresponding 95% confidence intervals are reported by taking average of LS means of change from baseline in monthly itch scores obtained over 24 weeks using equal weighting for all time points. Analyzed using Mixed Model Repeated Measures (MMRM) method.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Intent to Treat (ITT) set that included all randomized participants. Participants in the ITT Population were classified according to the treatment as randomized.'}, {'type': 'SECONDARY', 'title': 'Part A: Mean Change From Baseline in Weekly Itch Score at Week 2 Using NRS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Linerixibat 40 Milligrams (mg)', 'description': 'Participants were randomized to receive linerixibat 40 mg tablet orally twice a day (BID) in Part A (up to Week 24).'}, {'id': 'OG001', 'title': 'Part A: Placebo', 'description': 'Participants were randomized to receive Placebo orally twice a day (BID) in Part A (up to Week 24).'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.78', 'groupId': 'OG000', 'lowerLimit': '-2.08', 'upperLimit': '-1.48'}, {'value': '-1.07', 'groupId': 'OG001', 'lowerLimit': '-1.37', 'upperLimit': '-0.77'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.71', 'ciLowerLimit': '-1.07', 'ciUpperLimit': '-0.34', 'pValueComment': 'Adjusted for multiplicity as per Statistical Analysis Plan (SAP)', 'groupDescription': 'The mixed model repeated measures analysis includes Treatment Group, Week, Week\\*Treatment Group interaction, Baseline Weekly Itch score (WIS), Visit\\*Baseline WIS interaction, Baseline Concomitant Itch Medication.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed Model Repeated Measures Analysis'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and at Week 2', 'description': 'Itch Score was assessed using a twice daily NRS, ranging from 0 to 10, where 0 represents no itching and 10 the worst imaginable itching. The worst daily itch score was defined as the worst of the two scores recorded daily. The weekly itch score was defined as the average of the worst daily itch scores in one week. Higher weekly itch scores indicate worse itching. Baseline is the average of the Worst Daily Itch scores in the 7 days prior to randomization (Day 1). Change from Baseline is defined as the Week 2 value minus baseline value. Key secondary endpoints were tested in a step-down/hierarchical approach. Mean Change from Baseline in Weekly Itch Score at Week 2 was the first endpoint tested in the hierarchical analysis. LS mean and the corresponding 95% confidence intervals are reported using Mixed Model Repeated Measures (MMRM) method.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ITT set that included all randomized participants. Participants in the ITT Population were classified according to the treatment as randomized. Only participants with data at baseline and at least one post-baseline time point were included'}, {'type': 'SECONDARY', 'title': 'Part A: Mean Change From Baseline in Monthly Sleep Score Over 24 Weeks Using NRS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Linerixibat 40 Milligrams (mg)', 'description': 'Participants were randomized to receive linerixibat 40 mg tablet orally twice a day (BID) in Part A (up to Week 24).'}, {'id': 'OG001', 'title': 'Part A: Placebo', 'description': 'Participants were randomized to receive Placebo orally twice a day (BID) in Part A (up to Week 24).'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.77', 'groupId': 'OG000', 'lowerLimit': '-3.15', 'upperLimit': '-2.38'}, {'value': '-2.24', 'groupId': 'OG001', 'lowerLimit': '-2.62', 'upperLimit': '-1.86'}]}]}], 'analyses': [{'pValue': '0.024', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.53', 'ciLowerLimit': '-0.98', 'ciUpperLimit': '-0.07', 'pValueComment': 'Adjusted for multiplicity as per Statistical Analysis Plan (SAP)', 'groupDescription': 'The mixed model repeated measures analysis includes Treatment Group, Visit, Visit\\*Treatment Group interaction, Baseline Monthly sleep score (MSS), Visit\\*Baseline MSS interaction, Baseline Concomitant Itch Medication.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed Model Repeated Measures Analysis'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline up to Week 24', 'description': 'Sleep Scores were assessed using an NRS scale, ranging from 0 to 10, where 0 represents no sleep interference and 10 is complete sleep interference. The weekly sleep scale is the average of the daily sleep scores for each week. The monthly sleep score was defined as the worst weekly sleep score for the month (4 weeks). Higher monthly sleep scores indicate higher impact on sleep. Baseline is the worst Weekly Sleep Score in the 28 days prior to randomization (Day 1). Change from Baseline is defined as the post dose value minus baseline value. LS means and the corresponding 95% confidence intervals are reported by taking average of LS means of change from baseline in monthly sleep scores obtained over 24 weeks using equal weighting for all time points analyzed using Mixed Model Repeated Measures (MMRM) method. Mean Change from Baseline in Monthly Sleep Score over 24 weeks was the second endpoint tested in the hierarchical analysis.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ITT set that included all randomized participants. Participants in the ITT Population were classified according to the treatment as randomized. Only participants with data at baseline and at least one post-baseline time point were included.'}, {'type': 'SECONDARY', 'title': 'Part A: Percentage of Responders Defined as Achieving More Than or Equal to (>=) 2-point Reduction From Baseline in the Monthly Itch Score at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Linerixibat 40 Milligrams (mg)', 'description': 'Participants were randomized to receive linerixibat 40 mg tablet orally twice a day (BID) in Part A (up to Week 24).'}, {'id': 'OG001', 'title': 'Part A: Placebo', 'description': 'Participants were randomized to receive Placebo orally twice a day (BID) in Part A (up to Week 24).'}], 'classes': [{'categories': [{'measurements': [{'value': '68.0', 'groupId': 'OG000'}, {'value': '64.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.539', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Percentage difference', 'ciPctValue': '95', 'paramValue': '4.0', 'ciLowerLimit': '-9.0', 'ciUpperLimit': '17.0', 'pValueComment': 'Adjusted for multiplicity as per Statistical Analysis Plan (SAP)', 'groupDescription': 'Cochran-Mantel-Haenszel (CMH) stratified analysis adjusted for baseline factors: Baseline Itch Severity (Moderate: \\>=4 and less than \\[\\<\\]7, Severe: \\>=7); Concomitant cholestatic pruritus treatment regimen (Regimen contains Bile Acid Binding Resin \\[BABR\\], Regimen does not contain BABR, No defined treatment). Multiple imputation of missing Monthly itch scores was done before deriving responder definitions. Imputed datasets were analyzed using the CMH method and combined.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 24', 'description': 'Monthly Itch Score was assessed using an NRS, ranging from 0 to 10, where 0 represents no itching and 10 the worst imaginable itching. The Monthly Itch Score was determined from the worst weekly itch score for the month (4 weeks). Baseline is the worst weekly itch score in the 28 days prior to randomization (Day 1). Responders were defined as participants achieving \\>=2-point reduction (improvement) from baseline in the Monthly Itch Score. Percentage of Responders achieving \\>= 2-point Reduction from Baseline in the Monthly Itch Score at Week 24 was the third endpoint tested in the hierarchical analysis.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ITT set that included all randomized participants. Participants in the ITT Population were classified according to the treatment as randomized. Percentage values were rounded to the nearest whole number.'}, {'type': 'SECONDARY', 'title': 'Part A: Percentage of Responders Achieving >=3-point Reduction From Baseline in the Monthly Itch Score at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Linerixibat 40 Milligrams (mg)', 'description': 'Participants were randomized to receive linerixibat 40 mg tablet orally twice a day (BID) in Part A (up to Week 24).'}, {'id': 'OG001', 'title': 'Part A: Placebo', 'description': 'Participants were randomized to receive Placebo orally twice a day (BID) in Part A (up to Week 24).'}], 'classes': [{'categories': [{'measurements': [{'value': '56.0', 'groupId': 'OG000'}, {'value': '43.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.043', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Percentage Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '13.0', 'ciLowerLimit': '0.0', 'ciUpperLimit': '27.0', 'pValueComment': 'Adjusted for multiplicity; two-sided p-values \\<0.05 were considered to be nominally significant as per SAP.', 'groupDescription': 'Cochran-Mantel-Haenszel (CMH) stratified analysis adjusted for baseline factors: Baseline Itch Severity (Moderate: \\>=4 and \\<7, Severe: \\>=7); Concomitant cholestatic pruritus treatment regimen (Regimen contains BABR, Regimen does not contain BABR, No defined treatment). Multiple imputation of missing Monthly itch scores was done before deriving responder definitions. Imputed datasets were analyzed using the CMH method and combined.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 24', 'description': 'Monthly Itch Score was assessed using an NRS, ranging from 0 to 10, where 0 represents no itching and 10 the worst imaginable itching. The Monthly Itch Score was determined from the worst weekly itch score for the month (4 weeks). Baseline is the worst weekly itch score in the 28 days prior to randomization. Responders were defined as participants achieving \\>=3-point reduction (improvement) from baseline in the Monthly Itch Score. Percentage of Responders achieving \\>= 3-point Reduction from Baseline in the Monthly Itch Score at Week 24 was the fourth endpoint to be tested in the hierarchical analysis.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ITT set that included all randomized participants. Participants in the ITT Population were classified according to the treatment as randomized. Percentage values were rounded to the nearest whole number.'}, {'type': 'SECONDARY', 'title': 'Part A: Percentage of Responders as Achieving a >=4-point Reduction From Baseline in the Monthly Itch Score at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Linerixibat 40 Milligrams (mg)', 'description': 'Participants were randomized to receive linerixibat 40 mg tablet orally twice a day (BID) in Part A (up to Week 24).'}, {'id': 'OG001', 'title': 'Part A: Placebo', 'description': 'Participants were randomized to receive Placebo orally twice a day (BID) in Part A (up to Week 24).'}], 'classes': [{'categories': [{'measurements': [{'value': '41.0', 'groupId': 'OG000'}, {'value': '29.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.058', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Percentage Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '12.0', 'ciLowerLimit': '-0.0', 'ciUpperLimit': '24.0', 'pValueComment': 'Adjusted for multiplicity; two-sided p-values \\<0.05 were considered to be nominally significant as per SAP.', 'groupDescription': 'Cochran-Mantel-Haenszel (CMH) stratified analysis adjusted for baseline factors: Baseline Itch Severity (Moderate: \\>=4 and \\<7, Severe: \\>=7); Concomitant cholestatic pruritus treatment regimen (Regimen contains BABR, Regimen does not contain BABR, No defined treatment). Multiple imputation of missing Monthly itch scores was done before deriving responder definitions. Imputed datasets were analyzed using the CMH method and combined.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 24', 'description': 'Monthly Itch Score was assessed using an NRS, ranging from 0 to 10, where 0 represents no itching and 10 the worst imaginable itching. The Monthly Itch Score was determined from the worst weekly itch score for the month (4 weeks). Baseline is the worst weekly itch score in the 28 days prior to randomization. Responders were defined as participants achieving \\>=4-point reduction (improvement) from baseline in the Monthly Itch Score. Percentage of Responders achieving \\>= 4-point Reduction from Baseline in the Monthly Itch Score at Week 24 was the fifth endpoint to be tested in the hierarchical analysis.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ITT set that included all randomized participants. Participants in the ITT Population were classified according to the treatment as randomized. Percentage values were rounded to the nearest whole number.'}, {'type': 'SECONDARY', 'title': 'Part A: Mean Change From Baseline in Primary Biliary Cholangitis-40 (PBC-40) Domain Scores at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Linerixibat 40 Milligrams (mg)', 'description': 'Participants were randomized to receive linerixibat 40 mg tablet orally twice a day (BID) in Part A (up to Week 24).'}, {'id': 'OG001', 'title': 'Part A: Placebo', 'description': 'Participants were randomized to receive Placebo orally twice a day (BID) in Part A (up to Week 24).'}], 'classes': [{'title': 'Cognitive (score range: 6 to 30)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.71', 'groupId': 'OG000', 'lowerLimit': '-1.60', 'upperLimit': '0.18'}, {'value': '-1.47', 'groupId': 'OG001', 'lowerLimit': '-2.36', 'upperLimit': '-0.58'}]}]}, {'title': 'Emotional (score range: 3 to 15)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.07', 'groupId': 'OG000', 'lowerLimit': '-1.57', 'upperLimit': '-0.57'}, {'value': '-1.34', 'groupId': 'OG001', 'lowerLimit': '-1.83', 'upperLimit': '-0.84'}]}]}, {'title': 'Fatigue (score range: 11 to 55)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.94', 'groupId': 'OG000', 'lowerLimit': '-4.63', 'upperLimit': '-1.26'}, {'value': '-4.54', 'groupId': 'OG001', 'lowerLimit': '-6.21', 'upperLimit': '-2.86'}]}]}, {'title': 'Itch (score range: 0 to 15)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.47', 'groupId': 'OG000', 'lowerLimit': '-4.08', 'upperLimit': '-2.86'}, {'value': '-2.89', 'groupId': 'OG001', 'lowerLimit': '-3.50', 'upperLimit': '-2.28'}]}]}, {'title': 'Social (score range: 8 to 50)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.57', 'groupId': 'OG000', 'lowerLimit': '-3.71', 'upperLimit': '-1.43'}, {'value': '-2.42', 'groupId': 'OG001', 'lowerLimit': '-3.56', 'upperLimit': '-1.29'}]}]}, {'title': 'Symptoms (score range: 6 to 35)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.54', 'groupId': 'OG000', 'lowerLimit': '-0.18', 'upperLimit': '1.25'}, {'value': '0.08', 'groupId': 'OG001', 'lowerLimit': '-0.62', 'upperLimit': '0.79'}]}]}], 'analyses': [{'pValue': '0.176', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.76', 'ciLowerLimit': '-0.34', 'ciUpperLimit': '1.86', 'pValueComment': 'Not adjusted for multiplicity; two-sided p- values \\<0.05 were considered to be nominally significant as per SAP.', 'groupDescription': 'The mixed model repeated measures analysis includes Treatment Group, Visit, Visit\\*Treatment Group interaction, Baseline PBC-40 domain scores, Visit\\*Baseline PBC-40 domain scores interaction, Baseline Concomitant Itch Medication.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed Model Repeated Measures Analysis', 'nonInferiorityComment': 'Cognitive'}, {'pValue': '0.403', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.27', 'ciLowerLimit': '-0.36', 'ciUpperLimit': '0.89', 'pValueComment': 'Not adjusted for multiplicity; two-sided p- values \\<0.05 were considered to be nominally significant as per SAP.', 'groupDescription': 'The mixed model repeated measures analysis includes Treatment Group, Visit, Visit\\*Treatment Group interaction, Baseline PBC-40 domain scores, Visit\\*Baseline PBC-40 domain scores interaction, Baseline Concomitant Itch Medication.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed Model Repeated Measures Analysis', 'nonInferiorityComment': 'Emotional'}, {'pValue': '0.132', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.59', 'ciLowerLimit': '-0.48', 'ciUpperLimit': '3.67', 'pValueComment': 'Not adjusted for multiplicity; two-sided p- values \\<0.05 were considered to be nominally significant as per SAP.', 'groupDescription': 'The mixed model repeated measures analysis includes Treatment Group, Visit, Visit\\*Treatment Group interaction, Baseline PBC-40 domain scores, Visit\\*Baseline PBC-40 domain scores interaction, Baseline Concomitant Itch Medication.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed Model Repeated Measures Analysis', 'nonInferiorityComment': 'Fatigue'}, {'pValue': '0.132', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.58', 'ciLowerLimit': '-1.34', 'ciUpperLimit': '0.18', 'pValueComment': 'Not adjusted for multiplicity; two-sided p- values \\<0.05 were considered to be nominally significant as per SAP.', 'groupDescription': 'The mixed model repeated measures analysis includes Treatment Group, Visit, Visit\\*Treatment Group interaction, Baseline PBC-40 domain scores, Visit\\*Baseline PBC-40 domain scores interaction, Baseline Concomitant Itch Medication.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed Model Repeated Measures Analysis', 'nonInferiorityComment': 'Itch'}, {'pValue': '0.836', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.15', 'ciLowerLimit': '-1.57', 'ciUpperLimit': '1.27', 'pValueComment': 'Not adjusted for multiplicity; two-sided p- values \\<0.05 were considered to be nominally significant as per SAP.', 'groupDescription': 'The mixed model repeated measures analysis includes Treatment Group, Visit, Visit\\*Treatment Group interaction, Baseline PBC-40 domain scores, Visit\\*Baseline PBC-40 domain scores interaction, Baseline Concomitant Itch Medication.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed Model Repeated Measures Analysis', 'nonInferiorityComment': 'Social'}, {'pValue': '0.318', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.45', 'ciLowerLimit': '-0.44', 'ciUpperLimit': '1.34', 'pValueComment': 'Not adjusted for multiplicity; two-sided p- values \\<0.05 were considered to be nominally significant as per SAP.', 'groupDescription': 'The mixed model repeated measures analysis includes Treatment Group, Visit, Visit\\*Treatment Group interaction, Baseline PBC-40 domain scores, Visit\\*Baseline PBC-40 domain scores interaction, Baseline Concomitant Itch Medication.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed Model Repeated Measures Analysis', 'nonInferiorityComment': 'Symptoms'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline up to Week 24', 'description': 'PBC-40 is a disease-specific health-related quality of life (HRQoL) questionnaire validated for use in participants with PBC. It consists of 40 questions, which are grouped into 6 domains with 3 to 11 questions per domain. Each question is scored from 1 (least impact) to 5 (greatest impact). For all questions, an answer of "Does/Did not apply" was scored 0. All questions within a domain are summed to obtain individual domain score. Domains were: Symptoms (7 questions) with score range 6 to 35, Itch (3 questions) with score range 0 to 15, Fatigue (11 questions) with score range 11 to 55 , Cognitive (6 questions) with score range 6 to 30 , Emotional (3 questions) with score range 3 to 15 and Social (10 questions) with score range 8 to 50 . Higher scores for individual domains represent poorer quality of life. Baseline is the last assessment prior to the first dose of randomized treatment (Day 1). Change from Baseline was calculated as Week 24 value minus Baseline value.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population set included all randomized participants. Participants in the ITT Population were classified according to the treatment as randomized. Number of Participants Analyzed (N) was the maximum number of participants analyzed for any domain, while Number analyzed (n) was the number of participants included in the model for each domain.'}, {'type': 'SECONDARY', 'title': "Part A: Mean Change From Baseline in Patient's Global Impression of Severity (PGI-S) Over 24 Weeks", 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Linerixibat 40 Milligrams (mg)', 'description': 'Participants were randomized to receive linerixibat 40 mg tablet orally twice a day (BID) in Part A (up to Week 24).'}, {'id': 'OG001', 'title': 'Part A: Placebo', 'description': 'Participants were randomized to receive Placebo orally twice a day (BID) in Part A (up to Week 24).'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.22', 'groupId': 'OG000', 'lowerLimit': '-1.36', 'upperLimit': '-1.07'}, {'value': '-0.84', 'groupId': 'OG001', 'lowerLimit': '-0.99', 'upperLimit': '-0.70'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.37', 'ciLowerLimit': '-0.55', 'ciUpperLimit': '-0.20', 'pValueComment': 'Not adjusted for multiplicity; two-sided p- values \\<0.05 were considered to be nominally significant as per SAP.', 'groupDescription': 'The mixed model repeated measures analysis includes Treatment Group, Visit, Visit\\*Treatment Group interaction, Baseline PGI-S score, Visit\\*Baseline PGI-S score interaction, Baseline Concomitant Itch Medication.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed Model Repeated Measures Analysis'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and up to Week 24', 'description': "The Patient's Global Impression of Severity (PGI-S) is a patient-reported outcome measure used to assess the severity of symptoms from the participant's perspective. The PGI-S asks participant to rate the severity of their itch in the past 7 days on a single item, using a scale ranging from 0 (absent) to 5 (very severe). Higher score indicates higher severity. Baseline is the last assessment prior to the first dose of randomized treatment for Part A (Day 1). Change from Baseline is defined as the post dose value minus baseline value. LS means and the corresponding 95% confidence intervals are reported by taking average of LS means of change from baseline in PGI-S obtained over 24 weeks using equal weighting for all time points, analyzed using Mixed Model Repeated Measures (MMRM) method.", 'unitOfMeasure': 'Scores on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ITT set that included all randomized participants. Participants in the ITT Population were classified according to the treatment as randomized. Only participants with data at baseline and at least one post-baseline time point were included.'}, {'type': 'SECONDARY', 'title': "Part A: Patient's Global Impression of Change (PGI-C) Scores Over 24 Weeks", 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Linerixibat 40 Milligrams (mg)', 'description': 'Participants were randomized to receive linerixibat 40 mg tablet orally twice a day (BID) in Part A (up to Week 24).'}, {'id': 'OG001', 'title': 'Part A: Placebo', 'description': 'Participants were randomized to receive Placebo orally twice a day (BID) in Part A (up to Week 24).'}], 'classes': [{'categories': [{'measurements': [{'value': '1.97', 'groupId': 'OG000', 'lowerLimit': '1.74', 'upperLimit': '2.20'}, {'value': '2.46', 'groupId': 'OG001', 'lowerLimit': '2.23', 'upperLimit': '2.69'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.49', 'ciLowerLimit': '-0.76', 'ciUpperLimit': '-0.21', 'pValueComment': 'Not adjusted for multiplicity; two-sided p- values \\<0.05 were considered to be nominally significant as per SAP.', 'groupDescription': 'The mixed model repeated measures analysis includes Treatment Group, Visit, Visit\\*Treatment Group interaction, Baseline Concomitant Itch Medication.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed Model Repeated Measures Analysis'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 4 up to Week 24', 'description': "Patient's Global Impression of Change (PGI-C) was assessed using a 7-level response scale, ranging from 1 (very much improved) to 7 (very much worse). Higher score indicates higher level of change. LS means and the corresponding 95% confidence intervals are reported by taking average of LS means of PGI-C obtained over 24 weeks using equal weighting for all timepoints, analyzed using Mixed Model Repeated Measures (MMRM) method.", 'unitOfMeasure': 'Scores on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ITT set that included all randomized participants. Participants in the ITT Population were classified according to the treatment as randomized. Only participants with data for at least one time point were included.'}, {'type': 'SECONDARY', 'title': 'Part A: Mean Change From Baseline in Alkaline Phosphatase (ALP) at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Linerixibat 40 Milligrams (mg)', 'description': 'Participants were randomized to receive linerixibat 40 mg tablet orally twice a day (BID) in Part A (up to Week 24).'}, {'id': 'OG001', 'title': 'Part A: Placebo', 'description': 'Participants were randomized to receive Placebo orally twice a day (BID) in Part A (up to Week 24).'}], 'classes': [{'categories': [{'measurements': [{'value': '10.61', 'groupId': 'OG000', 'lowerLimit': '-8.53', 'upperLimit': '29.74'}, {'value': '-8.03', 'groupId': 'OG001', 'lowerLimit': '-26.79', 'upperLimit': '10.74'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 24', 'description': 'Blood samples were collected at indicated time points for evaluation of ALP. Change from Baseline in ALP at Week 24 was evaluated. Baseline was established using an average of two sets of laboratory values obtained at least 4 weeks apart within 56 days prior to randomization (Day 1). Change from Baseline was calculated as Week 24 value minus Baseline value.', 'unitOfMeasure': 'International units per liter (IU/L)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ITT set that included all randomized participants. Participants in the ITT Population were classified according to the treatment as randomized. Only participants with data at baseline and at least one post-baseline time point were included.'}, {'type': 'SECONDARY', 'title': 'Part A: Mean Change From Baseline in Bilirubin at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Linerixibat 40 Milligrams (mg)', 'description': 'Participants were randomized to receive linerixibat 40 mg tablet orally twice a day (BID) in Part A (up to Week 24).'}, {'id': 'OG001', 'title': 'Part A: Placebo', 'description': 'Participants were randomized to receive Placebo orally twice a day (BID) in Part A (up to Week 24).'}], 'classes': [{'categories': [{'measurements': [{'value': '1.77', 'groupId': 'OG000', 'lowerLimit': '0.84', 'upperLimit': '2.71'}, {'value': '-0.31', 'groupId': 'OG001', 'lowerLimit': '-1.24', 'upperLimit': '0.62'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 24', 'description': 'Blood samples were collected at indicated time points for evaluation of Bilirubin. Change from Baseline in total bilirubin at Week 24 was evaluated. Baseline was established using an average of two sets of laboratory values obtained at least 4 weeks apart within 56 days prior to randomization (Day 1). Change from Baseline was calculated as Week 24 value minus Baseline value.', 'unitOfMeasure': 'Micromoles per Liter (mmol/L)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ITT set that included all randomized participants. Participants in the ITT Population were classified according to the treatment as randomized. Only participants with data at baseline and at least one post-baseline time point were included.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Part A: Linerixibat 40 Milligrams (mg)', 'description': 'Participants were randomized to receive linerixibat 40 mg tablet orally twice a day (BID) in Part A (up to Week 24).'}, {'id': 'FG001', 'title': 'Part A: Placebo', 'description': 'Participants were randomized to receive Placebo orally twice a day (BID) in Part A (up to Week 24).'}, {'id': 'FG002', 'title': 'Part B: Placebo in Part A and Part B', 'description': 'Participants who were randomized to receive Placebo (up to Week 24) orally twice a day (BID) in Part A, continued to receive Placebo (from Week 24 to Week 32) orally twice a day (BID) in Part B.'}, {'id': 'FG003', 'title': 'Part B: Placebo in Part A and Linerixibat 40 mg in Part B', 'description': 'Participants who were randomized to receive Placebo (up to Week 24) orally twice a day (BID) in Part A, switched to receive linerixibat 40 mg tablet orally twice a day (BID) (from Week 24 to Week 32) in Part B.'}, {'id': 'FG004', 'title': 'Part B: Linerixibat 40 mg in Part A and Placebo in Part B', 'description': 'Participants who were randomized to receive linerixibat 40 mg tablet orally BID (up to Week 24) in Part A, switched to receive Placebo (from Week 24 to Week 32) orally twice a day (BID) in Part B.'}, {'id': 'FG005', 'title': 'Part B: Linerixibat 40 mg in Part A and Part B', 'description': 'Participants who were randomized to receive linerixibat 40 mg tablet orally twice a day (BID) (up to Week 24) in Part A, continued to receive linerixibat 40 mg twice a day (BID) (from Week 24 to Week 32) in Part B.'}], 'periods': [{'title': 'Part A (Day 1 to Week 24)', 'milestones': [{'type': 'STARTED', 'comment': 'Intent-to-Treat (ITT) Population: All participants randomly assigned to study treatment.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '119'}, {'groupId': 'FG001', 'numSubjects': '119'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Safety Population', 'comment': 'Safety Population: All randomized participants who take at least 1 dose of study intervention. Participants will be analyzed according to the treatment they actually received.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '119'}, {'groupId': 'FG001', 'numSubjects': '118'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '103'}, {'groupId': 'FG001', 'numSubjects': '108'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Part B (Week 24 to Week 32)', 'milestones': [{'type': 'STARTED', 'comment': 'ITT Population of Part B included all participants who completed the Part A.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'comment': 'Participants continued from Part A.', 'groupId': 'FG002', 'numSubjects': '55'}, {'comment': 'Participants continued from Part A', 'groupId': 'FG003', 'numSubjects': '53'}, {'comment': 'Participants continued from Part A', 'groupId': 'FG004', 'numSubjects': '49'}, {'comment': 'Participants continued from Part A', 'groupId': 'FG005', 'numSubjects': '54'}]}, {'type': 'Safety Population', 'comment': 'Safety Population: All participants who received at least 1 dose in Part B.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '53'}, {'groupId': 'FG003', 'numSubjects': '52'}, {'groupId': 'FG004', 'numSubjects': '46'}, {'groupId': 'FG005', 'numSubjects': '45'}]}, {'type': 'COMPLETED', 'comment': 'All participants who continued from Part A until the End of follow up period.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '55'}, {'groupId': 'FG003', 'numSubjects': '53'}, {'groupId': 'FG004', 'numSubjects': '49'}, {'groupId': 'FG005', 'numSubjects': '49'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '4'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'A total of 238 participants from Europe, North America, Latin America and Asia were enrolled and randomized.', 'preAssignmentDetails': 'This study was conducted in 2 parts: Part A and Part B. Participants were randomized in 1:1:1:1 ratio to receive either: linerixibat 40 milligram (mg) twice a day (BID) in Part A and Part B, linerixibat 40mg twice a day (BID) in Part A and placebo in Part B, placebo in Part A and Part B, or placebo in Part A and linerixibat 40mg twice a day (BID) in Part B.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'BG000'}, {'value': '119', 'groupId': 'BG001'}, {'value': '238', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Part A: Linerixibat 40 Milligrams (mg)', 'description': 'Participants were randomized to receive linerixibat 40 mg tablet orally twice a day (BID) in Part A (up to Week 24).'}, {'id': 'BG001', 'title': 'Part A: Placebo', 'description': 'Participants were randomized to receive Placebo orally twice a day (BID) in Part A (up to Week 24).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '18-49 Years', 'categories': [{'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}]}]}, {'title': '50-64 Years', 'categories': [{'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}]}]}, {'title': '>=65 Years', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '113', 'groupId': 'BG000'}, {'value': '113', 'groupId': 'BG001'}, {'value': '226', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'HISPANIC OR LATINO', 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}]}, {'title': 'NOT HISPANIC OR LATINO', 'categories': [{'measurements': [{'value': '85', 'groupId': 'BG000'}, {'value': '95', 'groupId': 'BG001'}, {'value': '180', 'groupId': 'BG002'}]}]}, {'title': 'UNKNOWN', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The analysis was performed on Intent-to Treat (ITT) population which included all randomized participants. Participants were classified according to the treatment as randomized.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-11-20', 'size': 2034682, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-07-02T17:13', 'hasProtocol': True}, {'date': '2024-11-08', 'size': 1228123, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-07-02T17:13', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Participants and investigator will be blinded to the study treatment.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be randomized to receive linerixibat and/or placebo during the study.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 238}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-08-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'nctId': 'NCT05448170', 'statusForNctId': 'AVAILABLE', 'hasExpandedAccess': True}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2024-12-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-02', 'studyFirstSubmitDate': '2021-06-25', 'resultsFirstSubmitDate': '2025-07-02', 'studyFirstSubmitQcDate': '2021-06-25', 'lastUpdatePostDateStruct': {'date': '2025-07-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-07-02', 'studyFirstPostDateStruct': {'date': '2021-07-06', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-07-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Part A: Mean Change From Baseline in Monthly Itch Scores Over 24 Weeks Using Numerical Rating Scale (NRS)', 'timeFrame': 'Baseline and up to Week 24', 'description': 'Itch Scores were assessed using a NRS twice daily, ranging from 0 to 10, where 0 represents no itching and 10 the worst imaginable itching. The worst daily itch score was defined as the worst of the two scores recorded daily. The weekly itch score was defined as the average of the worst daily itch scores in one week. The monthly itch score was defined as the worst weekly itch score for the month (4 weeks). Higher monthly itch scores indicate worse itching. Baseline is the worst weekly itch score in the 28 days prior to randomization (Day 1). Change from Baseline is defined as the post dose value minus baseline value. Least-squares (LS) means and the corresponding 95% confidence intervals are reported by taking average of LS means of change from baseline in monthly itch scores obtained over 24 weeks using equal weighting for all time points. Analyzed using Mixed Model Repeated Measures (MMRM) method.'}], 'secondaryOutcomes': [{'measure': 'Part A: Mean Change From Baseline in Weekly Itch Score at Week 2 Using NRS', 'timeFrame': 'Baseline and at Week 2', 'description': 'Itch Score was assessed using a twice daily NRS, ranging from 0 to 10, where 0 represents no itching and 10 the worst imaginable itching. The worst daily itch score was defined as the worst of the two scores recorded daily. The weekly itch score was defined as the average of the worst daily itch scores in one week. Higher weekly itch scores indicate worse itching. Baseline is the average of the Worst Daily Itch scores in the 7 days prior to randomization (Day 1). Change from Baseline is defined as the Week 2 value minus baseline value. Key secondary endpoints were tested in a step-down/hierarchical approach. Mean Change from Baseline in Weekly Itch Score at Week 2 was the first endpoint tested in the hierarchical analysis. LS mean and the corresponding 95% confidence intervals are reported using Mixed Model Repeated Measures (MMRM) method.'}, {'measure': 'Part A: Mean Change From Baseline in Monthly Sleep Score Over 24 Weeks Using NRS', 'timeFrame': 'Baseline up to Week 24', 'description': 'Sleep Scores were assessed using an NRS scale, ranging from 0 to 10, where 0 represents no sleep interference and 10 is complete sleep interference. The weekly sleep scale is the average of the daily sleep scores for each week. The monthly sleep score was defined as the worst weekly sleep score for the month (4 weeks). Higher monthly sleep scores indicate higher impact on sleep. Baseline is the worst Weekly Sleep Score in the 28 days prior to randomization (Day 1). Change from Baseline is defined as the post dose value minus baseline value. LS means and the corresponding 95% confidence intervals are reported by taking average of LS means of change from baseline in monthly sleep scores obtained over 24 weeks using equal weighting for all time points analyzed using Mixed Model Repeated Measures (MMRM) method. Mean Change from Baseline in Monthly Sleep Score over 24 weeks was the second endpoint tested in the hierarchical analysis.'}, {'measure': 'Part A: Percentage of Responders Defined as Achieving More Than or Equal to (>=) 2-point Reduction From Baseline in the Monthly Itch Score at Week 24', 'timeFrame': 'At Week 24', 'description': 'Monthly Itch Score was assessed using an NRS, ranging from 0 to 10, where 0 represents no itching and 10 the worst imaginable itching. The Monthly Itch Score was determined from the worst weekly itch score for the month (4 weeks). Baseline is the worst weekly itch score in the 28 days prior to randomization (Day 1). Responders were defined as participants achieving \\>=2-point reduction (improvement) from baseline in the Monthly Itch Score. Percentage of Responders achieving \\>= 2-point Reduction from Baseline in the Monthly Itch Score at Week 24 was the third endpoint tested in the hierarchical analysis.'}, {'measure': 'Part A: Percentage of Responders Achieving >=3-point Reduction From Baseline in the Monthly Itch Score at Week 24', 'timeFrame': 'At Week 24', 'description': 'Monthly Itch Score was assessed using an NRS, ranging from 0 to 10, where 0 represents no itching and 10 the worst imaginable itching. The Monthly Itch Score was determined from the worst weekly itch score for the month (4 weeks). Baseline is the worst weekly itch score in the 28 days prior to randomization. Responders were defined as participants achieving \\>=3-point reduction (improvement) from baseline in the Monthly Itch Score. Percentage of Responders achieving \\>= 3-point Reduction from Baseline in the Monthly Itch Score at Week 24 was the fourth endpoint to be tested in the hierarchical analysis.'}, {'measure': 'Part A: Percentage of Responders as Achieving a >=4-point Reduction From Baseline in the Monthly Itch Score at Week 24', 'timeFrame': 'At Week 24', 'description': 'Monthly Itch Score was assessed using an NRS, ranging from 0 to 10, where 0 represents no itching and 10 the worst imaginable itching. The Monthly Itch Score was determined from the worst weekly itch score for the month (4 weeks). Baseline is the worst weekly itch score in the 28 days prior to randomization. Responders were defined as participants achieving \\>=4-point reduction (improvement) from baseline in the Monthly Itch Score. Percentage of Responders achieving \\>= 4-point Reduction from Baseline in the Monthly Itch Score at Week 24 was the fifth endpoint to be tested in the hierarchical analysis.'}, {'measure': 'Part A: Mean Change From Baseline in Primary Biliary Cholangitis-40 (PBC-40) Domain Scores at Week 24', 'timeFrame': 'Baseline up to Week 24', 'description': 'PBC-40 is a disease-specific health-related quality of life (HRQoL) questionnaire validated for use in participants with PBC. It consists of 40 questions, which are grouped into 6 domains with 3 to 11 questions per domain. Each question is scored from 1 (least impact) to 5 (greatest impact). For all questions, an answer of "Does/Did not apply" was scored 0. All questions within a domain are summed to obtain individual domain score. Domains were: Symptoms (7 questions) with score range 6 to 35, Itch (3 questions) with score range 0 to 15, Fatigue (11 questions) with score range 11 to 55 , Cognitive (6 questions) with score range 6 to 30 , Emotional (3 questions) with score range 3 to 15 and Social (10 questions) with score range 8 to 50 . Higher scores for individual domains represent poorer quality of life. Baseline is the last assessment prior to the first dose of randomized treatment (Day 1). Change from Baseline was calculated as Week 24 value minus Baseline value.'}, {'measure': "Part A: Mean Change From Baseline in Patient's Global Impression of Severity (PGI-S) Over 24 Weeks", 'timeFrame': 'Baseline and up to Week 24', 'description': "The Patient's Global Impression of Severity (PGI-S) is a patient-reported outcome measure used to assess the severity of symptoms from the participant's perspective. The PGI-S asks participant to rate the severity of their itch in the past 7 days on a single item, using a scale ranging from 0 (absent) to 5 (very severe). Higher score indicates higher severity. Baseline is the last assessment prior to the first dose of randomized treatment for Part A (Day 1). Change from Baseline is defined as the post dose value minus baseline value. LS means and the corresponding 95% confidence intervals are reported by taking average of LS means of change from baseline in PGI-S obtained over 24 weeks using equal weighting for all time points, analyzed using Mixed Model Repeated Measures (MMRM) method."}, {'measure': "Part A: Patient's Global Impression of Change (PGI-C) Scores Over 24 Weeks", 'timeFrame': 'Week 4 up to Week 24', 'description': "Patient's Global Impression of Change (PGI-C) was assessed using a 7-level response scale, ranging from 1 (very much improved) to 7 (very much worse). Higher score indicates higher level of change. LS means and the corresponding 95% confidence intervals are reported by taking average of LS means of PGI-C obtained over 24 weeks using equal weighting for all timepoints, analyzed using Mixed Model Repeated Measures (MMRM) method."}, {'measure': 'Part A: Mean Change From Baseline in Alkaline Phosphatase (ALP) at Week 24', 'timeFrame': 'Baseline and Week 24', 'description': 'Blood samples were collected at indicated time points for evaluation of ALP. Change from Baseline in ALP at Week 24 was evaluated. Baseline was established using an average of two sets of laboratory values obtained at least 4 weeks apart within 56 days prior to randomization (Day 1). Change from Baseline was calculated as Week 24 value minus Baseline value.'}, {'measure': 'Part A: Mean Change From Baseline in Bilirubin at Week 24', 'timeFrame': 'Baseline and Week 24', 'description': 'Blood samples were collected at indicated time points for evaluation of Bilirubin. Change from Baseline in total bilirubin at Week 24 was evaluated. Baseline was established using an average of two sets of laboratory values obtained at least 4 weeks apart within 56 days prior to randomization (Day 1). Change from Baseline was calculated as Week 24 value minus Baseline value.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cholestasis', 'GLISTEN', 'GSK2330672', 'Itch', 'Primary biliary cholangitis', 'Pruritus'], 'conditions': ['Pruritus']}, 'referencesModule': {'references': [{'pmid': '41173016', 'type': 'DERIVED', 'citation': 'Hirschfield GM, Bowlus CL, Jones DEJ, Kremer AE, Mayo MJ, Tanaka A, Andreone P, Jia J, Jin Q, Macias-Rodriguez RU, Cobitz AR, Currie BM, Gorey C, Lazic I, Podmore D, Ribeiro A, Shannon JB, Swift B, McLaughlin MM, Levy C; GLISTEN Study Group. Linerixibat in patients with primary biliary cholangitis and cholestatic pruritus (GLISTEN): a randomised, multicentre, double-blind, placebo-controlled, phase 3 trial. Lancet Gastroenterol Hepatol. 2025 Oct 28:S2468-1253(25)00192-X. doi: 10.1016/S2468-1253(25)00192-X. Online ahead of print.'}, {'pmid': '37953500', 'type': 'DERIVED', 'citation': 'Carreno F, Karatza E, Mehta R, Collins J, Austin D, Swift B. Population Dose-Response-Time Analysis of Itch Reduction and Patient-Reported Tolerability Supports Phase III Dose Selection for Linerixibat. Clin Pharmacol Ther. 2024 Feb;115(2):288-298. doi: 10.1002/cpt.3103. Epub 2023 Dec 3.'}]}, 'descriptionModule': {'briefSummary': 'This is a 2-part study in PBC participants with cholestatic pruritus and will evaluate the efficacy, safety and impact on health-related quality of life of linerixibat compared with placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female participants must be between 18 to 80 years of age inclusive, at the time of signing the informed consent.\n* Participants who have documented PBC.\n* Participants who have moderate to severe itch.\n\nExclusion Criteria:\n\n* Total bilirubin \\>2.0 times Upper Limit of Normal (ULN) using the average of two Baseline measures.\n* Screening Alanine Aminotransferase (ALT) \\> 6 times ULN in a single Baseline measure or ALT \\> 5 times ULN using the average of two Baseline measures.\n* Screening estimated glomerular filtration rate (eGFR) \\<30 milliliter per minute per 1.73 square meter (mL/min/1.73m\\^2).\n* History or presence of hepatic decompensation (e.g., variceal bleeding, hepatic encephalopathy or ascites).\n* Presence of HBsAg positive hepatitis B or hepatitis C (HCV) (anti-HCV and Ribonucleic acid \\[RNA\\] detected) infection, primary sclerosing cholangitis (PSC), alcoholic liver disease and/or confirmed hepatocellular carcinoma or biliary cancer.\n* Current clinically significant diarrhea or active inflammatory ileal disease according to Investigator´s clinical judgment.\n* Current symptomatic cholelithiasis or cholecystitis.\n* Current diagnosis of primary skin disorders with itch as a characteristic feature (e.g., atopic dermatitis, psoriasis).\n* Primary sleep disorders such as but are not limited to sleep apnea, narcolepsy, hypersomnia.\n* Initiation, discontinuation or change in dose of ursodeoxycholic acid (UDCA), bezafibrate or fenofibrate in the 8 weeks prior to Screening.\n* Use of obeticholic acid: within 8 weeks prior to Screening. (Participants may not initiate or restart during the study).\n* Initiation, discontinuation, or change in dose of any of the following in the 8 weeks prior to Screening: bile acid binding resins, rifampicin, naltrexone, naloxone, nalfurafine, pregabalin, gabapentin, sertraline or other selective serotonin reuptake inhibitor (SSRIs), antihistamines used for the treatment of itching.\n* Administration of any other human ileal bile acid transporter (IBAT) inhibitor in the 12 weeks prior to screening.\n* Any planned procedures intended to treat cholestatic pruritus such as nasobiliary drainage or ultraviolet light therapy from Screening and throughout the study.\n* History of sensitivity or intolerance to the study treatment.'}, 'identificationModule': {'nctId': 'NCT04950127', 'briefTitle': 'Global Linerixibat Itch Study of Efficacy and Safety in Primary Biliary Cholangitis (PBC) (GLISTEN)', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'A Two-part, Randomized, Placebo Controlled, Double Blind, Multicenter, Phase 3 Study to Evaluate the Efficacy and Safety of Linerixibat for the Treatment of Cholestatic Pruritus in Participants With Primary Biliary Cholangitis (PBC)', 'orgStudyIdInfo': {'id': '212620'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part A: Linerixibat 40 milligrams (mg)', 'description': 'Participants were randomized to receive linerixibat 40 mg tablet orally twice a day (BID) in Part A (up to Week 24).', 'interventionNames': ['Drug: Linerixibat']}, {'type': 'EXPERIMENTAL', 'label': 'Part A: Placebo', 'description': 'Participants were randomized to receive Placebo orally twice a day (BID) in Part A (up to Week 24).', 'interventionNames': ['Drug: Linerixibat', 'Drug: Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Part B: Placebo in Part A and Part B', 'description': 'Participants who were randomized to receive Placebo (up to Week 24) orally twice a day (BID) in Part A, continued to receive Placebo (from Week 24 to Week 32) orally twice a day (BID) in Part B.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part B: Placebo in Part A and Linerixibat 40 mg in Part B', 'description': 'Participants who were randomized to receive Placebo (up to Week 24) orally twice a day (BID) in Part A, switched to receive linerixibat 40 mg tablet orally twice a day (BID) (from Week 24 to Week 32) in Part B.', 'interventionNames': ['Drug: Linerixibat', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part B: Linerixibat 40 mg in Part A and Placebo in Part B', 'description': 'Participants who were randomized to receive linerixibat 40 mg tablet orally BID (up to Week 24) in Part A, switched to receive Placebo (from Week 24 to Week 32) orally twice a day (BID) in Part B.', 'interventionNames': ['Drug: Linerixibat', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part B: Linerixibat 40 mg in Part A and Part B', 'description': 'Participants who were randomized to receive linerixibat 40 mg tablet orally twice a day (BID) (up to Week 24) in Part A, continued to receive linerixibat 40 mg twice a day (BID) (from Week 24 to Week 32) in Part B.', 'interventionNames': ['Drug: Linerixibat']}], 'interventions': [{'name': 'Linerixibat', 'type': 'DRUG', 'description': 'Participants will receive linerixibat.', 'armGroupLabels': ['Part A: Linerixibat 40 milligrams (mg)', 'Part A: Placebo', 'Part B: Linerixibat 40 mg in Part A and Part B', 'Part B: Linerixibat 40 mg in Part A and Placebo in Part B', 'Part B: Placebo in Part A and Linerixibat 40 mg in Part B']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Participants will receive placebo.', 'armGroupLabels': ['Part A: Placebo', 'Part B: Linerixibat 40 mg in Part A and Placebo in Part B', 'Part B: Placebo in Part A and Linerixibat 40 mg in Part B', 'Part B: Placebo in Part A and Part B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95817', 'city': 'Davis', 'state': 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