Study of OCA in Combination with BZF Evaluating Efficacy, Safety, and Tolerability in Participants with PBC
Phase 2
Active, not recruiting
- Conditions
- Primary Biliary Cholangitis
- Interventions
- Registration Number
- NCT04594694
- Lead Sponsor
- Intercept Pharmaceuticals
- Brief Summary
Study to evaluate the efficacy, safety, and tolerability of investigational drug obeticholic acid (OCA) in combination with the investigational drug bezafibrate (BZF) in participants with Primary Biliary Cholangitis (PBC).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 72
Inclusion Criteria
- 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
Exclusion Criteria
- History or presence of other concomitant liver diseases
- Clinical complications of PBC
- History or presence of hepatic 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 other farnesoid X receptor (FXR) agonists, or participation in a previous study involving OCA 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 Treatment C: OCA 5 mg to 10 mg + BZF 200 mg IR Bezafibrate 200 MG Participants will receive OCA 5 mg to 10 mg + BZF 200 mg IR + BZF 400 mg Placebo Treatment D: OCA 5 mg to 10 mg + BZF 400 mg SR Bezafibrate 400 MG Participants will receive OCA 5 mg to 10 mg + BZF 400 mg SR + BZF 200 mg Placebo Treatment A: BZF 200 milligrams (mg) Immediate release (IR) OCA Placebo Participants will receive Bezafibrate (BZF) 200 mg IR + OCA Placebo + BZF 400 mg Placebo Treatment B: BZF 400 mg SR Bezafibrate 200 mg Placebo Participants will receive BZF 400 mg SR + OCA Placebo + BZF 200 mg Placebo Treatment B: BZF 400 mg SR Bezafibrate 400 MG Participants will receive BZF 400 mg SR + OCA Placebo + BZF 200 mg Placebo Treatment A: BZF 200 milligrams (mg) Immediate release (IR) Bezafibrate 200 MG Participants will receive Bezafibrate (BZF) 200 mg IR + OCA Placebo + BZF 400 mg Placebo Treatment A: BZF 200 milligrams (mg) Immediate release (IR) Bezafibrate 400 mg Placebo Participants will receive Bezafibrate (BZF) 200 mg IR + OCA Placebo + BZF 400 mg Placebo Treatment B: BZF 400 mg SR OCA Placebo Participants will receive BZF 400 mg SR + OCA Placebo + BZF 200 mg Placebo Treatment C: OCA 5 mg to 10 mg + BZF 200 mg IR Obeticholic acid Participants will receive OCA 5 mg to 10 mg + BZF 200 mg IR + BZF 400 mg Placebo Treatment D: OCA 5 mg to 10 mg + BZF 400 mg SR Obeticholic acid Participants will receive OCA 5 mg to 10 mg + BZF 400 mg SR + BZF 200 mg Placebo Treatment D: OCA 5 mg to 10 mg + BZF 400 mg SR Bezafibrate 200 mg Placebo Participants will receive OCA 5 mg to 10 mg + BZF 400 mg SR + BZF 200 mg Placebo Long-term safety extension (LTSE) phase: OCA + BZF OCA Participants will continue the original treatment assignment allocated during the DB Period. The OCA and BZF dose may be optimized based on safety and efficacy during the DB period. Treatment C: OCA 5 mg to 10 mg + BZF 200 mg IR Bezafibrate 400 mg Placebo Participants will receive OCA 5 mg to 10 mg + BZF 200 mg IR + BZF 400 mg Placebo Long-term safety extension (LTSE) phase: OCA + BZF Bezafibrate Participants will continue the original treatment assignment allocated during the DB Period. The OCA and BZF dose may be optimized based on safety and efficacy during the DB period.
- Primary Outcome Measures
Name Time Method Change in Alkaline Phosphatase (ALP) from baseline to Week 12 in the DB Treatment Period Baseline, Day 1, and Weeks 4, 8, and 12
- Secondary Outcome Measures
Name Time Method Number of participants with normalization rates of biochemical disease marker Alanine Aminotransferase (ALT), Gamma-Glutamyl Transpeptidase (GGT), Aspartate Aminotransferase (AST), total and conjugated bilirubin and lipid panel Baseline, Day 1, and Weeks 2, 4, 6, 8, and 12 Change in ALT from baseline to Week 12 Baseline, Day 1, and Weeks 4, 8, and 12 Change in GGT from baseline to Week 12 Baseline, Day 1, and Weeks 4, 8, and 12 Response rates of ≥10%, ≥20%, ≥30% and ≥40% reduction, and normalization of biochemical disease marker Alkaline Phosphatase (ALP) Baseline, Day 1, and Weeks 2, 4, 6, 8, and 12 Change in AST from baseline to Week 12 Baseline, Day 1, and Weeks 4, 8, and 12 Change in total and conjugated bilirubin from baseline to Week 12 Baseline, Day 1, and Weeks 4, 8, and 12 Change in 7 alpha (α) hydroxy 4 cholesten-3 one (C4) from baseline to Week 12 Baseline, Day 1, and Weeks 4, 8, and 12 Change in lipid panel from baseline to Week 12 Baseline, Day 1, and Weeks 4, 8, and 12 Change in bile acid from baseline to Week 12 Baseline, Day 1, and Weeks 4,8, and 12
Trial Locations
- Locations (33)
Flinders Medical Centre
🇦🇺Bedford Park, Perth, Australia
Royal Adelaide Hospital
🇦🇺Adelaide, Australia
UZ Gasthuisberg
🇧🇪Leuven, Belgium
Clinical Hospital Dubrava
🇭🇷Zagreb, Croatia
Zagreb University Hospital Center
🇭🇷Zagreb, Croatia
Hepato-Gastroenterologie HK, s.r.o.
🇨🇿Hradec Kralove, Czechia
Artroscan s.r.o., Gastroenterologicka ambulance
🇨🇿Ostrava, Czechia
Research Site s.r.o.
🇨🇿Plzen, Czechia
Tartu University Hospital
🇪🇪Tartu, Estonia
Hôpital Henri Mondor
🇫🇷Créteil, France
Scroll for more (23 remaining)Flinders Medical Centre🇦🇺Bedford Park, Perth, Australia