Study of OCA in Combination With BZF Evaluating Efficacy, Safety and Tolerability in Participants With PBC
- Conditions
- Primary Biliary Cholangitis
- Interventions
- Drug: Obeticholic Acid placeboDrug: Obeticholic Acid 5 mg
- Registration Number
- NCT05239468
- Lead Sponsor
- Intercept Pharmaceuticals
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 60
- A definite or probable diagnosis of PBC
- Qualifying ALP and/or bilirubin liver biochemistry values
- Taking ursodeoxycholic acid (UDCA) for at least 12 months or no UDCA for 3 months before Day 1
- History or presence of other concomitant liver diseases
- Presence of clinical complications of PBC
- History or presence of decompensating events
- Current or history of gallbladder disease
- If female, known pregnancy, or has a positive urine pregnancy test (confirmed by a positive serum pregnancy test), or lactating
- 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
- 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.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Double Blind (DB) Phase Treatment B: BZF 400 mg IR tablet Bezafibrate 200 mg Each Participant will take one OCA placebo tablet and two BZF 200 mg IR tablets (to achieve 400 mg dose) daily. Long Term Safety Extension (LTSE) Phase Treatment D of the DB phase: OCA 5 mg + BZF 400 mg IR Bezafibrate 200 mg Each participant will take one OCA 5 mg tablet and two BZF 200 mg IR tablets (to achieve 400 mg dose) daily. Double Blind (DB) Phase Treatment A: BZF 100 milligrams (mg) Immediate Release (IR) tablet Bezafibrate 100 mg Each Participant will take one OCA placebo tablet, one BZF 100 mg IR tablet and one BZF placebo tablet daily. Double Blind (DB) Phase Treatment A: BZF 100 milligrams (mg) Immediate Release (IR) tablet Obeticholic Acid placebo Each Participant will take one OCA placebo tablet, one BZF 100 mg IR tablet and one BZF placebo tablet daily. Double Blind (DB) Phase Treatment A: BZF 100 milligrams (mg) Immediate Release (IR) tablet Bezafibrate Placebo Each Participant will take one OCA placebo tablet, one BZF 100 mg IR tablet and one BZF placebo tablet daily. Double Blind (DB) Phase Treatment B: BZF 400 mg IR tablet Obeticholic Acid placebo Each Participant will take one OCA placebo tablet and two BZF 200 mg IR tablets (to achieve 400 mg dose) daily. Double Blind (DB) Phase Treatment C: OCA 5 mg + BZF 100 mg IR Bezafibrate 100 mg Each participant will take one OCA 5 mg tablet, one BZF 100 mg IR tablet and one BZF placebo tablet, daily. Double Blind (DB) Phase Treatment C: OCA 5 mg + BZF 100 mg IR Obeticholic Acid 5 mg Each participant will take one OCA 5 mg tablet, one BZF 100 mg IR tablet and one BZF placebo tablet, daily. Double Blind (DB) Phase Treatment C: OCA 5 mg + BZF 100 mg IR Bezafibrate Placebo Each participant will take one OCA 5 mg tablet, one BZF 100 mg IR tablet and one BZF placebo tablet, daily. Double Blind (DB) Phase Treatment D: OCA 5 mg + BZF 400 mg IR Bezafibrate 200 mg Each participant will take one OCA 5 mg tablet and two BZF 200 mg IR tablets (to achieve 400 mg dose) daily. Double Blind (DB) Phase Treatment D: OCA 5 mg + BZF 400 mg IR Obeticholic Acid 5 mg Each participant will take one OCA 5 mg tablet and two BZF 200 mg IR tablets (to achieve 400 mg dose) daily. Long Term Safety Extension (LTSE) Phase Treatment D of the DB phase: OCA 5 mg + BZF 400 mg IR Obeticholic Acid 5 mg Each participant will take one OCA 5 mg tablet and two BZF 200 mg IR tablets (to achieve 400 mg dose) daily.
- Primary Outcome Measures
Name Time Method Change in Alkaline Phosphatase (ALP) from Baseline to Week 12 Baseline, and at Weeks 2, 4, 6, 8, 10 and 12
- Secondary Outcome Measures
Name Time Method Change from Baseline in biochemical disease markers, total & conjugated bilirubin Baseline and at Weeks 2, 4, 6, 8, 10 and 12 Change from Baseline in lipid panel Baseline and at Weeks 2, 4, 6, 8, 10 and 12 Change from Baseline of the plasma value of 7 alpha (α) hydroxy 4 cholesten-3 one (C4) Baseline and at Weeks 2, 4, 6, 8, 10, and 12 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 Baseline and at Weeks 2, 4, 6, 8, 10 and 12 Change from Baseline in biochemical disease marker ALT Baseline and at Weeks 2, 4, 6, 8, 10 and 12 Change from Baseline in biochemical disease marker AST Baseline and at Weeks 2, 4, 6, 8, 10 and 12 Change from Baseline of the plasma value of bile acids, in unit of nanograms per milliliter (ng/ml) Baseline and at Weeks 2, 4, 6, 8, 10, and 12 Number of participants with normalization rates of alanine aminotransferase (ALT), gamma-glutamyl transferase (GGT), alanine aminotransferase (AST), total and conjugated bilirubin and lipid panel Baseline and at Weeks 2, 4, 6, 8, 10 and 12 Change from Baseline in biochemical disease marker GGT Baseline and at Weeks 2, 4, 6, 8, 10 and 12
Trial Locations
- Locations (17)
Methodist Clinical Research Institute (CRI)
🇺🇸Dallas, Texas, United States
University Hospitals Cleveland Medical Center
🇺🇸Cleveland, Ohio, United States
Beth Israel Deaconess Medical Center Harvard Liver Research Center
🇺🇸Boston, Massachusetts, United States
Houston Methodist Cancer Center
🇺🇸Houston, Texas, United States
Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
Wake Endoscopy Center
🇺🇸Raleigh, North Carolina, United States
Gastro One
🇺🇸Germantown, Tennessee, United States
NYU Langone Medical Center
🇺🇸New York, New York, United States
Schiff Center for Liver Diseases / University of Miami
🇺🇸Miami, Florida, United States
Southern California Gastrointestinal (GI) and Liver Centers (SCLC) - Coronado
🇺🇸Coronado, California, United States
Facey Medical Group
🇺🇸Mission Hills, California, United States
Ochsner Medical Center
🇺🇸New Orleans, Louisiana, United States
Gastrointestinal Associates of Northeast Tennessee
🇺🇸Johnson City, Tennessee, United States
Piedmont Atlanta Hospital
🇺🇸Atlanta, Georgia, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
American Research Corporation at the Texas Liver Institute
🇺🇸San Antonio, Texas, United States
Tampa General Medical Group
🇺🇸Tampa, Florida, United States