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

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ClinicalTrials.gov Identifier: NCT05239468
Recruitment Status : Recruiting
First Posted : February 15, 2022
Last Update Posted : August 25, 2022
Sponsor:
Information provided by (Responsible Party):
Intercept Pharmaceuticals

Study Description
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Brief Summary:
Study to determine the effect of the investigational drug bezafibrate (BZF) alone and in combination with the investigational drug obeticholic acid (also known as OCA) in patients with Primary Biliary Cholangitis (also known as PBC).

Condition or disease Intervention/treatment Phase
Primary Biliary Cholangitis Drug: Bezafibrate 100 MG Drug: Bezafibrate 200 MG Drug: Obeticholic Acid 5 MG Drug: Obeticholic Acid placebo Drug: Bezafibrate Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : March 21, 2022
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Double Blind (DB) Phase Treatment A: BZF 100 mg Immediate Release (IR) tablet
Each subject will take one OCA placebo tablet, one BZF 100 mg IR tablet and one BZF placebo tablet daily.
 Drug: Bezafibrate 100 MG
One tablet of bezafibrate 100mg IR once daily

Drug: Obeticholic Acid placebo
One tablet of obeticholic acid placebo tablet once daily

Drug: Bezafibrate Placebo
One tablet of bezafibrate placebo tablet once daily
Active Comparator: Double Blind (DB) Phase Treatment B: BZF 400 mg IR tablet
Each subject will take one OCA placebo tablet and two BZF 200 mg IR tablets (to achieve 400 mg dose) daily
 Drug: Bezafibrate 200 MG
Two tablets of bezafibrate 200 mg IR once daily for BZF 400 mg IR

Drug: Obeticholic Acid placebo
One tablet of obeticholic acid placebo tablet once daily
Experimental: Double Blind (DB) Phase Treatment C: OCA 5 mg + BZF 100 mg IR
Each subject will take one OCA 5 mg tablet, one BZF 100 mg IR tablet and one BZF placebo tablet, daily.
 Drug: Bezafibrate 100 MG
One tablet of bezafibrate 100mg IR once daily

Drug: Obeticholic Acid 5 MG
One tablet of obeticholic acid 5 mg tablet once daily

Drug: Bezafibrate Placebo
One tablet of bezafibrate placebo tablet once daily
Experimental: Double Blind (DB) Phase Treatment D: OCA 5 mg + BZF 400 mg IR
Each subject will take one OCA 5 mg tablet and two BZF 200 mg IR tablets (to achieve 400 mg dose) daily.
 Drug: Bezafibrate 200 MG
Two tablets of bezafibrate 200 mg IR once daily for BZF 400 mg IR

Drug: Obeticholic Acid 5 MG
One tablet of obeticholic acid 5 mg tablet once daily


Outcome Measures
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Primary Outcome Measures :
  1. Change in Alkaline Phosphatase (ALP) from baseline to Week 12 in the Double Blind (DB) Phase [ Time Frame: Baseline, and Week 4, 8 and 12 ]

Secondary Outcome Measures :
  1. Response rates of 10 percent, 20 percent, and 40 percent reduction and normalization of biochemical disease marker ALP [ Time Frame: Baseline, Day 1, and Week 2, 4, 6, 8, 10 and 12 ]
  2. Response rates of 10 percent, 20 percent, and 40 percent reduction and normalization of biochemical disease marker Alanine Aminotransferase (ALT) [ Time Frame: Baseline, Day 1, and Week 2, 4, 6, 8, 10 and 12 ]
  3. Response rates of 10 percent, 20 percent, and 40 percent reduction and normalization of biochemical disease marker Gamma-Glutamyl Transpeptidase (GGT) [ Time Frame: Baseline, Day 1, and Week 2, 4, 6, 8, 10 and 12 ]
  4. Response rates of 10 percent, 20 percent, and 40 percent reduction and normalization of biochemical disease marker Aspartate Aminotransferase (AST) [ Time Frame: Baseline, Day 1, and Week 2, 4, 6, 8, 10 and 12 ]
  5. Response rates of 10 percent, 20 percent, and 40 percent reduction and normalization of biochemical disease markers total & conjugated bilirubin [ Time Frame: Baseline, Day 1, and Week 2, 4, 6, 8, 10 and 12 ]
  6. Biomarkers of bile acid synthesis: change from baseline of the plasma value of 7α hydroxy 4 cholesten-3 one (C4) [ Time Frame: Day 1 and Week 2, 4, 6, 8, 10, 12, 36 and 60 ]
  7. Biomarkers of bile acid homeostasis: change from baseline of the plasma value of bile acids, in unit of ng/ml. [ Time Frame: Day 1 and Week 2, 4, 6, 8, 10, 12, 36 and 60 ]
  8. Safety and tolerability as assessed by the incidence of treatment emergent adverse events and serious treatment emergent adverse events [ Time Frame: Baseline, Day 1, and Week 2, 4, 6, 8, 10, 12, 16, 20, 24, 36, 48 and 60 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 FXR agonists, or peroxisome proliferator activated receptor (PPAR)-agonists within 3 months before Screening
  • Treatment with commercially available fibrates, or participation in a previous study involving fibrate within 3 months before Screening
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05239468


Contacts
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Contact: Erminia Cafasso 1-973-945-9359 erminia.cafasso@interceptpharma.com

Locations
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Sponsors and Collaborators
Intercept Pharmaceuticals
Investigators
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Study Director: Lynda Szczech, M.D. Intercept Pharmaceuticals, Inc
More Information
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Responsible Party: Intercept Pharmaceuticals
ClinicalTrials.gov Identifier: NCT05239468    
Other Study ID Numbers: 747-214
First Posted: February 15, 2022    Key Record Dates
Last Update Posted: August 25, 2022
Last Verified: August 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Intercept Pharmaceuticals:
Primary Biliary Cholangitis
Primary Biliary Cirrhosis
PBC
 Hepatic Impairment
Cirrhosis
Liver
Additional relevant MeSH terms:
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Cholangitis
Liver Cirrhosis, Biliary
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Cholestasis, Intrahepatic
Cholestasis
Liver Diseases
Liver Cirrhosis
Fibrosis
 Pathologic Processes
Chenodeoxycholic Acid
Bezafibrate
Cathartics
Gastrointestinal Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents