Loyola University Medical Center

Gottlieb Memorial Hospital

MacNeal Hospital

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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

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

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.

Disease(s) and\or Condition(s)

Primary Biliary Cholangitis

Primary Purpose
  • TREATMENT
Intervention/Treatment
    • Type: DRUG
    • Name: Bezafibrate 100 mg
    • Description: One tablet of bezafibrate 100 mg IR once daily
    • Arm Group Labels: 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
    • Type: DRUG
    • Name: Bezafibrate 200 mg
    • Description: Two tablets of bezafibrate 200 mg IR once daily for BZF 400 mg IR
    • Arm Group Labels: 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
    • Type: DRUG
    • Name: Obeticholic Acid 5 mg
    • Description: One tablet of obeticholic acid 5 mg tablet once daily.
    • Arm Group Labels: 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
    • Type: DRUG
    • Name: Obeticholic Acid placebo
    • Description: One tablet of obeticholic acid placebo tablet once daily
    • Arm Group Labels: 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
    • Type: DRUG
    • Name: Bezafibrate Placebo
    • Description: One tablet of bezafibrate placebo tablet once daily
    • Arm Group Labels: 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
Sponsor
  • Intercept Pharmaceuticals