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Clinical trial

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

ID
Name
747-214
Description
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).
Trial arms
Trial start
2022-03-21
Estimated PCD
2024-08-01
Trial end
2024-08-01
Status
Active (not recruiting)
Phase
Early phase I
Treatment
Bezafibrate 100 mg
One tablet of bezafibrate 100 mg IR once daily
Arms:
Double Blind (DB) Phase Treatment A: BZF 100 milligrams (mg) Immediate Release (IR) tablet, Double Blind (DB) Phase Treatment C: OCA 5 mg + BZF 100 mg IR
Bezafibrate 200 mg
Two tablets of bezafibrate 200 mg IR once daily for BZF 400 mg IR
Arms:
Double Blind (DB) Phase Treatment B: BZF 400 mg IR tablet, Double Blind (DB) Phase Treatment D: OCA 5 mg + BZF 400 mg IR, Long Term Safety Extension (LTSE) Phase Treatment D of the DB phase: OCA 5 mg + BZF 400 mg IR
Obeticholic Acid 5 mg
One tablet of obeticholic acid 5 mg tablet once daily.
Arms:
Double Blind (DB) Phase Treatment C: OCA 5 mg + BZF 100 mg IR, Double Blind (DB) Phase Treatment D: OCA 5 mg + BZF 400 mg IR, Long Term Safety Extension (LTSE) Phase Treatment D of the DB phase: OCA 5 mg + BZF 400 mg IR
Obeticholic Acid placebo
One tablet of obeticholic acid placebo tablet once daily
Arms:
Double Blind (DB) Phase Treatment A: BZF 100 milligrams (mg) Immediate Release (IR) tablet, Double Blind (DB) Phase Treatment B: BZF 400 mg IR tablet
Bezafibrate Placebo
One tablet of bezafibrate placebo tablet once daily
Arms:
Double Blind (DB) Phase Treatment A: BZF 100 milligrams (mg) Immediate Release (IR) tablet, Double Blind (DB) Phase Treatment C: OCA 5 mg + BZF 100 mg IR
Size
60
Primary endpoint
Change in Alkaline Phosphatase (ALP) from Baseline to Week 12
Baseline, and at Weeks 2, 4, 6, 8, 10 and 12
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 60, 'type': 'ESTIMATED'}}
Updated at
2024-04-08

1 organization

3 products

1 indication

Product
Bezafibrate
Indication
Primary Biliary Cholangitis
Organization
Intercept Pharmaceuticals
Product
Obeticholic Acid
Product
Obeticholic acid