Clinical trial NCT05239468: Study of OCA in Combination With BZF Evaluating Efficacy, Safety and Tolerability in Participants With PBC
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Primary Biliary Cholangitis
Keywords: Primary Biliary Cholangitis
Primary Biliary Cirrhosis
Hepatic Impairment
Cirrhosis
Liver
Lead sponsor: Intercept Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2022-02-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Change in Alkaline Phosphatase (ALP) from Baseline to Week 12
timeFrame: Baseline, and at Weeks 2, 4, 6, 8, 10 and 12
Secondary outcomes:
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
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Coronado
country: United States
facility: Southern California Gastrointestinal (GI) and Liver Centers (SCLC) - Coronado
state: California
city: Mission Hills
country: United States
facility: Facey Medical Group
state: California
city: Miami
country: United States
facility: Schiff Center for Liver Diseases / University of Miami
state: Florida
city: Tampa
country: United States
facility: Tampa General Medical Group
state: Florida
city: Atlanta
country: United States
facility: Piedmont Atlanta Hospital
state: Georgia
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
city: New Orleans
country: United States
facility: Ochsner Medical Center
state: Louisiana
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center Harvard Liver Research Center
state: Massachusetts
city: New York
country: United States
facility: NYU Langone Medical Center
state: New York
city: Raleigh
country: United States
facility: Wake Endoscopy Center
state: North Carolina
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Germantown
country: United States
facility: Gastro One
state: Tennessee
city: Johnson City
country: United States
facility: Gastrointestinal Associates of Northeast Tennessee
state: Tennessee
city: Dallas
country: United States
facility: Methodist Clinical Research Institute (CRI)
state: Texas
city: Houston
country: United States
facility: Houston Methodist Cancer Center
state: Texas
city: San Antonio
country: United States
facility: American Research Corporation at the Texas Liver Institute
state: Texas
Study officials:
affiliation: Intercept Pharmaceuticals, Inc
name: Lynda Szczech, M.D.
role: STUDY_DIRECTOR
References: