Study of OCA in Combination With BZF Evaluating Efficacy, Safety and Tolerability in Participants With PBC

Intercept Pharmaceuticals72 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Primary Biliary Cholangitis

Interventions

Bezafibrate 100 mgDRUG

One tablet of bezafibrate 100 mg IR once daily

Bezafibrate 200 mgDRUG

Two tablets of bezafibrate 200 mg IR once daily for BZF 400 mg IR

Obeticholic Acid 5 mgDRUG

One tablet of obeticholic acid 5 mg tablet once daily.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (26)

Outcomes

Primary Outcomes

Change in Alkaline Phosphatase (ALP) from Baseline to Week 12

Time frame: Baseline, and at Weeks 2, 4, 6, 8, 10 and 12

Secondary Outcomes

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