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

Intercept Pharmaceuticals

Status and phase: Active, not recruiting; Phase 2

Conditions: Primary Biliary Cholangitis

Treatments: Drug: Obeticholic Acid placebo; Drug: Obeticholic Acid 5 mg; Drug: Bezafibrate Placebo; Drug: Bezafibrate 200 mg; Drug: Bezafibrate 100 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT05239468

747-214

Details and patient eligibility

About

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).

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 5 patient groups

Double Blind (DB) Phase Treatment A: BZF 100 milligrams (mg) Immediate Release (IR) tablet

Active Comparator group

Description:

Each Participant will take one OCA placebo tablet, one BZF 100 mg IR tablet and one BZF placebo tablet daily.

Treatment:

Drug: Bezafibrate 100 mg

Drug: Bezafibrate Placebo

Drug: Obeticholic Acid placebo

Double Blind (DB) Phase Treatment B: BZF 400 mg IR tablet

Active Comparator group

Description:

Each Participant will take one OCA placebo tablet and two BZF 200 mg IR tablets (to achieve 400 mg dose) daily.

Treatment:

Drug: Bezafibrate 200 mg

Drug: Obeticholic Acid placebo

Double Blind (DB) Phase Treatment C: OCA 5 mg + BZF 100 mg IR

Experimental group

Description:

Each participant will take one OCA 5 mg tablet, one BZF 100 mg IR tablet and one BZF placebo tablet, daily.

Treatment:

Drug: Bezafibrate 100 mg

Drug: Bezafibrate Placebo

Drug: Obeticholic Acid 5 mg

Double Blind (DB) Phase Treatment D: OCA 5 mg + BZF 400 mg IR

Experimental group

Description:

Each participant will take one OCA 5 mg tablet and two BZF 200 mg IR tablets (to achieve 400 mg dose) daily.

Treatment:

Drug: Bezafibrate 200 mg

Drug: Obeticholic Acid 5 mg

Long Term Safety Extension (LTSE) Phase Treatment D of the DB phase: OCA 5 mg + BZF 400 mg IR

Experimental group

Description:

Each participant will take one OCA 5 mg tablet and two BZF 200 mg IR tablets (to achieve 400 mg dose) daily.

Treatment:

Drug: Bezafibrate 200 mg

Drug: Obeticholic Acid 5 mg