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

Primary Biliary Cholangitis Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05239468
• Other study ID #: 747-214
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: March 21, 2022
• Est. completion date: August 2024

Study information

• Verified date: April 2024
• Source: Intercept Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cholangitis
• Liver Cirrhosis, Biliary
• Primary Biliary Cholangitis

Intervention

Drug:
• Bezafibrate 100 mg
One tablet of bezafibrate 100 mg IR once daily
• Bezafibrate 200 mg
Two tablets of bezafibrate 200 mg IR once daily for BZF 400 mg IR
• Obeticholic Acid 5 mg
One tablet of obeticholic acid 5 mg tablet once daily.
• Obeticholic Acid placebo
One tablet of obeticholic acid placebo tablet once daily
• Bezafibrate Placebo
One tablet of bezafibrate placebo tablet once daily

Locations

Country	Name	City	State
United States	Piedmont Atlanta Hospital	Atlanta	Georgia
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Beth Israel Deaconess Medical Center Harvard Liver Research Center	Boston	Massachusetts
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio
United States	Southern California Gastrointestinal (GI) and Liver Centers (SCLC) - Coronado	Coronado	California
United States	Methodist Clinical Research Institute (CRI)	Dallas	Texas
United States	Gastro One	Germantown	Tennessee
United States	Houston Methodist Cancer Center	Houston	Texas
United States	Gastrointestinal Associates of Northeast Tennessee	Johnson City	Tennessee
United States	Loyola University Medical Center	Maywood	Illinois
United States	Schiff Center for Liver Diseases / University of Miami	Miami	Florida
United States	Facey Medical Group	Mission Hills	California
United States	Ochsner Medical Center	New Orleans	Louisiana
United States	NYU Langone Medical Center	New York	New York
United States	Henry Ford Health System	Novi	Michigan
United States	Wake Endoscopy Center	Raleigh	North Carolina
United States	American Research Corporation at the Texas Liver Institute	San Antonio	Texas
United States	Tampa General Medical Group	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Intercept Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Alkaline Phosphatase (ALP) from Baseline to Week 12		Baseline, and at Weeks 2, 4, 6, 8, 10 and 12
Secondary	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
Secondary	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
Secondary	Change from Baseline in biochemical disease marker GGT		Baseline and at Weeks 2, 4, 6, 8, 10 and 12
Secondary	Change from Baseline in biochemical disease marker ALT		Baseline and at Weeks 2, 4, 6, 8, 10 and 12
Secondary	Change from Baseline in biochemical disease marker AST		Baseline and at Weeks 2, 4, 6, 8, 10 and 12
Secondary	Change from Baseline in biochemical disease markers, total & conjugated bilirubin		Baseline and at Weeks 2, 4, 6, 8, 10 and 12
Secondary	Change from Baseline in lipid panel		Baseline and at Weeks 2, 4, 6, 8, 10 and 12
Secondary	Change from Baseline of the plasma value of 7 alpha (a) hydroxy 4 cholesten-3 one (C4)		Baseline and at Weeks 2, 4, 6, 8, 10, and 12
Secondary	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