Study of OCA in Combination With BZF Evaluating Efficacy, Safety and Tolerability in Participants With PBC
Phase 2
Completed
- 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
- COMPLETED
- 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
- 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 (26)
Hospital Italiano La Plata
🇦🇷La Plata, Buenos Aires, Argentina
DIM Clinical Privada
🇦🇷Ramos Mejía, Buenos Aires, Argentina
Hospital Italiano de Buenos Aires
🇦🇷Buenos Aires, Argentina
Hospital Universitario Austral
🇦🇷Pilar, Argentina
Hospital Provincial del Centenario
🇦🇷Rosario, Argentina
The Northern Alberta Clinical Trials and Research Centre
🇨🇦Edmonton, Alberta, Canada
Pacific Gastroenterology Associates
🇨🇦Vancouver, British Columbia, Canada
University of Montreal
🇨🇦Montreal, Quebec, Canada
Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola-Malpighi
🇮🇹Bologna, Italy
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
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