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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04594694
Recruitment Status : Recruiting
First Posted : October 20, 2020
Last Update Posted : April 25, 2023
Sponsor:
Information provided by (Responsible Party):
Intercept Pharmaceuticals

Study Description
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Brief Summary:
Study to evaluate the efficacy, safety, and tolerability of investigational drug obeticholic acid (OCA) in combination with the investigational drug bezafibrate (BZF) in participants with Primary Biliary Cholangitis (PBC).

Condition or disease Intervention/treatment Phase
Primary Biliary Cholangitis Drug: Obeticholic acid Drug: Bezafibrate 200 MG Drug: OCA Placebo Drug: Bezafibrate 200 mg Placebo Drug: Bezafibrate 400 MG Drug: Bezafibrate 400 mg Placebo Drug: OCA Drug: Bezafibrate Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Double-Blind, Randomized, Parallel Group Study Evaluating the Efficacy, Safety, and Tolerability of Obeticholic Acid Administered in Combination With Bezafibrate in Subjects With Primary Biliary Cholangitis Who Had an Inadequate Response or Who Were Unable to Tolerate Ursodeoxycholic Acid
Actual Study Start Date : October 2, 2019
Estimated Primary Completion Date : October 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Treatment A: BZF 200 milligrams (mg) Immediate release (IR)
Participants will receive Bezafibrate (BZF) 200 mg IR + OCA Placebo + BZF 400 mg Placebo
 Drug: Bezafibrate 200 MG
200 mg IR tablet of Bezafibrate once daily for the remainder of the study

Drug: OCA Placebo
One tablet daily for the remainder of the study

Drug: Bezafibrate 400 mg Placebo
One tablet daily for the remainder of the study
Active Comparator: Treatment B: BZF 400 mg SR
Participants will receive BZF 400 mg SR + OCA Placebo + BZF 200 mg Placebo
 Drug: OCA Placebo
One tablet daily for the remainder of the study

Drug: Bezafibrate 200 mg Placebo
One tablet daily for the remainder of the study

Drug: Bezafibrate 400 MG
400 mg SR tablet of Bezafibrate once daily for the remainder of the study
Experimental: Treatment C: OCA 5 mg to 10 mg + BZF 200 mg IR
Participants will receive OCA 5 mg to 10 mg + BZF 200 mg IR + BZF 400 mg Placebo
 Drug: Obeticholic acid
5 mg tablet of OCA once daily titrating up to a maximum of 10 mg OCA once daily

Drug: Bezafibrate 200 MG
200 mg IR tablet of Bezafibrate once daily for the remainder of the study

Drug: Bezafibrate 400 mg Placebo
One tablet daily for the remainder of the study
Experimental: Treatment D: OCA 5 mg to 10 mg + BZF 400 mg SR
Participants will receive OCA 5 mg to 10 mg + BZF 400 mg SR + BZF 200 mg Placebo
 Drug: Obeticholic acid
5 mg tablet of OCA once daily titrating up to a maximum of 10 mg OCA once daily

Drug: Bezafibrate 200 mg Placebo
One tablet daily for the remainder of the study

Drug: Bezafibrate 400 MG
400 mg SR tablet of Bezafibrate once daily for the remainder of the study
Experimental: Long-term safety extension (LTSE) phase: OCA + BZF
Participants will continue the original treatment assignment allocated during the DB Period. The OCA and BZF dose may be optimized based on safety and efficacy during the DB period.
 Drug: OCA
OCA one tablet will be administered.

Drug: Bezafibrate
Bezafibrate one tablet will be administered.


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

Secondary Outcome Measures :
  1. Response rates of ≥10%, ≥20%, ≥30% and ≥40% reduction, and normalization of biochemical disease marker Alkaline Phosphatase (ALP) [ Time Frame: Baseline, Day 1, and Weeks 2, 4, 6, 8, and 12 ]
  2. Number of participants with normalization rates of biochemical disease marker Alanine Aminotransferase (ALT), Gamma-Glutamyl Transpeptidase (GGT), Aspartate Aminotransferase (AST), total and conjugated bilirubin and lipid panel [ Time Frame: Baseline, Day 1, and Weeks 2, 4, 6, 8, and 12 ]
  3. Change in GGT from baseline to Week 12 [ Time Frame: Baseline, Day 1, and Weeks 4, 8, and 12 ]
  4. Change in ALT from baseline to Week 12 [ Time Frame: Baseline, Day 1, and Weeks 4, 8, and 12 ]
  5. Change in AST from baseline to Week 12 [ Time Frame: Baseline, Day 1, and Weeks 4, 8, and 12 ]
  6. Change in total and conjugated bilirubin from baseline to Week 12 [ Time Frame: Baseline, Day 1, and Weeks 4, 8, and 12 ]
  7. Change in lipid panel from baseline to Week 12 [ Time Frame: Baseline, Day 1, and Weeks 4, 8, and 12 ]
  8. Change in 7 alpha (α) hydroxy 4 cholesten-3 one (C4) from baseline to Week 12 [ Time Frame: Baseline, Day 1, and Weeks 4, 8, and 12 ]
  9. Change in bile acid from baseline to Week 12 [ Time Frame: Baseline, Day 1, and Weeks 4,8, and 12 ]

Eligibility Criteria
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Information from the National Library of Medicine

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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
  • Clinical complications of PBC
  • History or presence of hepatic 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 other farnesoid X receptor (FXR) agonists, or participation in a previous study involving OCA within 3 months before Screening.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

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): NCT04594694


Contacts
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Contact: Natasha Warner +44 (0)7811 381956 Natasha.Warner@InterceptPharma.com
Contact: Erminia Cafasso erminia.cafasso@interceptpharma.com

Locations
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Sponsors and Collaborators
Intercept Pharmaceuticals
Investigators
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Study Director: Antonio Civitarese, M.D. Intercept Pharmaceuticals, Inc.
More Information
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Publications:

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Responsible Party: Intercept Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04594694    
Other Study ID Numbers: 747-213
First Posted: October 20, 2020    Key Record Dates
Last Update Posted: April 25, 2023
Last Verified: April 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: 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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Bezafibrate
Cholangitis
Liver Cirrhosis, Biliary
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Cholestasis, Intrahepatic
Cholestasis
 Liver Diseases
Liver Cirrhosis
Fibrosis
Pathologic Processes
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents