Ignite Creation Date:
2025-12-24 @ 6:26 PM
Ignite Modification Date:
2025-12-27 @ 5:32 AM
Study NCT ID:
NCT05239468
Status:
COMPLETED
Last Update Posted:
2025-09-25
First Post:
2022-01-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of OCA in Combination With BZF Evaluating Efficacy, Safety and Tolerability in Participants With PBC
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008105', 'term': 'Liver Cirrhosis, Biliary'}, {'id': 'D005355', 'term': 'Fibrosis'}], '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': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001629', 'term': 'Bezafibrate'}, {'id': 'C464660', 'term': 'obeticholic acid'}], 'ancestors': [{'id': 'D001549', 'term': 'Benzamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D058607', 'term': 'Fibric Acids'}, {'id': 'D058610', 'term': 'Isobutyrates'}, {'id': 'D002087', 'term': 'Butyrates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D001565', 'term': 'Benzoates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002723', 'term': 'Chlorobenzoates'}, {'id': 'D010647', 'term': 'Phenyl Ethers'}, {'id': 'D004987', 'term': 'Ethers'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D010636', 'term': 'Phenols'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-24', 'studyFirstSubmitDate': '2022-01-28', 'studyFirstSubmitQcDate': '2022-02-11', 'lastUpdatePostDateStruct': {'date': '2025-09-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-02-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Alkaline Phosphatase (ALP) from Baseline to Week 12', 'timeFrame': 'Baseline, and at Weeks 2, 4, 6, 8, 10 and 12'}], 'secondaryOutcomes': [{'measure': 'Change from Baseline in response rates of ≥10 percent, ≥20 percent, ≥30 percent and ≥40 percent reduction and normalization rates of biochemical disease marker ALP', 'timeFrame': 'Baseline and at Weeks 2, 4, 6, 8, 10 and 12'}, {'measure': 'Number of participants with normalization rates of alanine aminotransferase (ALT), gamma-glutamyl transferase (GGT), alanine aminotransferase (AST), total and conjugated bilirubin and lipid panel', 'timeFrame': 'Baseline and at Weeks 2, 4, 6, 8, 10 and 12'}, {'measure': 'Change from Baseline in biochemical disease marker GGT', 'timeFrame': 'Baseline and at Weeks 2, 4, 6, 8, 10 and 12'}, {'measure': 'Change from Baseline in biochemical disease marker ALT', 'timeFrame': 'Baseline and at Weeks 2, 4, 6, 8, 10 and 12'}, {'measure': 'Change from Baseline in biochemical disease marker AST', 'timeFrame': 'Baseline and at Weeks 2, 4, 6, 8, 10 and 12'}, {'measure': 'Change from Baseline in biochemical disease markers, total & conjugated bilirubin', 'timeFrame': 'Baseline and at Weeks 2, 4, 6, 8, 10 and 12'}, {'measure': 'Change from Baseline in lipid panel', 'timeFrame': 'Baseline and at Weeks 2, 4, 6, 8, 10 and 12'}, {'measure': 'Change from Baseline of the plasma value of 7 alpha (α) hydroxy 4 cholesten-3 one (C4)', 'timeFrame': 'Baseline and at Weeks 2, 4, 6, 8, 10, and 12'}, {'measure': 'Change from Baseline of the plasma value of bile acids, in unit of nanograms per milliliter (ng/ml)', 'timeFrame': 'Baseline and at Weeks 2, 4, 6, 8, 10, and 12'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Primary Biliary Cholangitis', 'Primary Biliary Cirrhosis', 'Hepatic Impairment', 'Cirrhosis', 'Liver'], 'conditions': ['Primary Biliary Cholangitis']}, 'descriptionModule': {'briefSummary': 'Study to determine the effect of the investigational drug bezafibrate (BZF) alone and in combination with the investigational drug obeticholic acid (OCA) in participants with Primary Biliary Cholangitis (PBC).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A definite or probable diagnosis of PBC\n* Qualifying ALP and/or bilirubin liver biochemistry values\n* Taking ursodeoxycholic acid (UDCA) for at least 12 months or no UDCA for 3 months before Day 1\n\nExclusion Criteria:\n\n* History or presence of other concomitant liver diseases\n* Presence of clinical complications of PBC\n* History or presence of decompensating events\n* Current or history of gallbladder disease\n* If female, known pregnancy, or has a positive urine pregnancy test (confirmed by a positive serum pregnancy test), or lactating\n* Treatment with commercially available OCA or participation in a previous study involving OCA, or other farnesoid X receptor (FXR) agonists, or peroxisome proliferator activated receptor (PPAR)-agonists within 3 months before Screening\n* Unable to tolerate BZF or other fibrates, treatment with commercially available fibrates, or participation in a previous study involving fibrate within 3 months before Screening.\n\nNote: Other protocol defined Inclusion/Exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT05239468', 'briefTitle': 'Study of OCA in Combination With BZF Evaluating Efficacy, Safety and Tolerability in Participants With PBC', 'organization': {'class': 'INDUSTRY', 'fullName': 'Intercept Pharmaceuticals'}, 'officialTitle': 'A Phase 2a, Double-Blind, Randomized, Active Controlled, Parallel Group Study Evaluating the Efficacy, Safety, and Tolerability of Bezafibrate Administered in Combination With Obeticholic Acid in Subjects With Primary Biliary Cholangitis', 'orgStudyIdInfo': {'id': '747-214'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Double Blind (DB) Phase Treatment A: BZF 100 milligrams (mg) Immediate Release (IR) tablet', 'description': 'Each Participant will take one OCA placebo tablet, one BZF 100 mg IR tablet and one BZF placebo tablet daily.', 'interventionNames': ['Drug: Bezafibrate 100 mg', 'Drug: Obeticholic Acid placebo', 'Drug: Bezafibrate Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Double Blind (DB) Phase Treatment B: BZF 400 mg IR tablet', 'description': 'Each Participant will take one OCA placebo tablet and two BZF 200 mg IR tablets (to achieve 400 mg dose) daily.', 'interventionNames': ['Drug: Bezafibrate 200 mg', 'Drug: Obeticholic Acid placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Double Blind (DB) Phase Treatment C: OCA 5 mg + BZF 100 mg IR', 'description': 'Each participant will take one OCA 5 mg tablet, one BZF 100 mg IR tablet and one BZF placebo tablet, daily.', 'interventionNames': ['Drug: Bezafibrate 100 mg', 'Drug: Obeticholic Acid 5 mg', 'Drug: Bezafibrate Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Double Blind (DB) Phase Treatment D: OCA 5 mg + BZF 400 mg IR', 'description': 'Each participant will take one OCA 5 mg tablet and two BZF 200 mg IR tablets (to achieve 400 mg dose) daily.', 'interventionNames': ['Drug: Bezafibrate 200 mg', 'Drug: Obeticholic Acid 5 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Long Term Safety Extension (LTSE) Phase Treatment D of the DB phase: OCA 5 mg + BZF 400 mg IR', 'description': 'Each participant will take one OCA 5 mg tablet and two BZF 200 mg IR tablets (to achieve 400 mg dose) daily.', 'interventionNames': ['Drug: Bezafibrate 200 mg', 'Drug: Obeticholic Acid 5 mg']}], 'interventions': [{'name': 'Bezafibrate 100 mg', 'type': 'DRUG', 'description': 'One tablet of bezafibrate 100 mg IR once daily', 'armGroupLabels': ['Double Blind (DB) Phase Treatment A: BZF 100 milligrams (mg) Immediate Release (IR) tablet', 'Double Blind (DB) Phase Treatment C: OCA 5 mg + BZF 100 mg IR']}, {'name': 'Bezafibrate 200 mg', 'type': 'DRUG', 'description': 'Two tablets of bezafibrate 200 mg IR once daily for BZF 400 mg IR', 'armGroupLabels': ['Double Blind (DB) Phase Treatment B: BZF 400 mg IR tablet', 'Double Blind (DB) Phase Treatment D: OCA 5 mg + BZF 400 mg IR', 'Long Term Safety Extension (LTSE) Phase Treatment D of the DB phase: OCA 5 mg + BZF 400 mg IR']}, {'name': 'Obeticholic Acid 5 mg', 'type': 'DRUG', 'description': 'One tablet of obeticholic acid 5 mg tablet once daily.', 'armGroupLabels': ['Double Blind (DB) Phase Treatment C: OCA 5 mg + BZF 100 mg IR', 'Double Blind (DB) Phase Treatment D: OCA 5 mg + BZF 400 mg IR', 'Long Term Safety Extension (LTSE) Phase Treatment D of the DB phase: OCA 5 mg + BZF 400 mg IR']}, {'name': 'Obeticholic Acid placebo', 'type': 'DRUG', 'description': 'One tablet of obeticholic acid placebo tablet once daily', 'armGroupLabels': ['Double Blind (DB) Phase Treatment A: BZF 100 milligrams (mg) Immediate Release (IR) tablet', 'Double Blind (DB) Phase Treatment B: BZF 400 mg IR tablet']}, {'name': 'Bezafibrate Placebo', 'type': 'DRUG', 'description': 'One tablet of bezafibrate placebo tablet once daily', 'armGroupLabels': ['Double Blind (DB) Phase Treatment A: BZF 100 milligrams (mg) Immediate Release (IR) tablet', 'Double Blind (DB) Phase Treatment C: OCA 5 mg + BZF 100 mg IR']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '92118', 'city': 'Coronado', 'state': 'California', 'country': 'United States', 'facility': 'Southern California Gastrointestinal (GI) and Liver Centers (SCLC) - Coronado', 'geoPoint': {'lat': 32.68589, 'lon': -117.18309}}, {'zip': '91345', 'city': 'Mission Hills', 'state': 'California', 'country': 'United States', 'facility': 'Facey Medical Group', 'geoPoint': {'lat': 34.68609, 'lon': -120.43683}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Schiff Center for Liver Diseases / University of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33606', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Tampa General Medical Group', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '30309', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Piedmont Atlanta Hospital', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60459', 'city': 'Maywood', 'state': 'Illinois', 'country': 'United States', 'facility': 'Loyola University Medical Center', 'geoPoint': {'lat': 41.8792, 'lon': -87.84312}}, {'zip': '70121', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Ochsner Medical Center', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Beth Israel Deaconess Medical Center Harvard Liver Research Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '10016-6402', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'NYU Langone Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27607', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Endoscopy Center', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'University Hospitals Cleveland Medical Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '38018', 'city': 'Cordova', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Gastro One', 'geoPoint': {'lat': 35.15565, 'lon': -89.7762}}, {'zip': '37604', 'city': 'Johnson City', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Gastrointestinal Associates of Northeast Tennessee', 'geoPoint': {'lat': 36.31344, 'lon': -82.35347}}, {'zip': '75203', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Methodist Clinical Research Institute (CRI)', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77030-2717', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Houston Methodist Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78215', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'American Research Corporation at the Texas Liver Institute', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'city': 'La Plata', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Hospital Italiano La Plata', 'geoPoint': {'lat': -34.92126, 'lon': -57.95442}}, {'city': 'Ramos Mejía', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'DIM Clinical Privada', 'geoPoint': {'lat': -34.6551, 'lon': -58.55318}}, {'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Hospital Italiano de Buenos Aires', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'city': 'Pilar', 'country': 'Argentina', 'facility': 'Hospital Universitario Austral', 'geoPoint': {'lat': -34.45867, 'lon': -58.91398}}, {'city': 'Rosario', 'country': 'Argentina', 'facility': 'Hospital Provincial del Centenario', 'geoPoint': {'lat': -32.94682, 'lon': -60.63932}}, {'zip': 'T6G 287', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'The Northern Alberta Clinical Trials and Research Centre', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'V6Z 2K5', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Pacific Gastroenterology Associates', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'University of Montreal', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'city': 'Bologna', 'country': 'Italy', 'facility': 'Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola-Malpighi', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}], 'overallOfficials': [{'name': 'Lynda Szczech, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Intercept Pharmaceuticals, Inc'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Intercept Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}