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: Bezafibrate 400 mg Placebo; Drug: Bezafibrate 200 MG; Drug: Bezafibrate 200 mg Placebo; Drug: Bezafibrate; Drug: OCA; Drug: OCA Placebo; Drug: Bezafibrate 400 MG; Drug: Obeticholic acid

Study type: Interventional

Funder types: Industry

Identifiers

NCT04594694

747-213

Details and patient eligibility

About

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).

Enrollment: 72 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
• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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72 participants in 5 patient groups

Treatment A: BZF 200 milligrams (mg) Immediate release (IR)

Active Comparator group

Description:

Participants will receive Bezafibrate (BZF) 200 mg IR + OCA Placebo + BZF 400 mg Placebo

Treatment:

Drug: OCA Placebo

Drug: Bezafibrate 200 MG

Drug: Bezafibrate 400 mg Placebo

Treatment B: BZF 400 mg SR

Active Comparator group

Description:

Participants will receive BZF 400 mg SR + OCA Placebo + BZF 200 mg Placebo

Treatment:

Drug: Bezafibrate 400 MG

Drug: OCA Placebo

Drug: Bezafibrate 200 mg Placebo

Treatment C: OCA 5 mg to 10 mg + BZF 200 mg IR

Experimental group

Description:

Participants will receive OCA 5 mg to 10 mg + BZF 200 mg IR + BZF 400 mg Placebo

Treatment:

Drug: Obeticholic acid

Drug: Bezafibrate 200 MG

Drug: Bezafibrate 400 mg Placebo

Treatment D: OCA 5 mg to 10 mg + BZF 400 mg SR

Experimental group

Description:

Participants will receive OCA 5 mg to 10 mg + BZF 400 mg SR + BZF 200 mg Placebo

Treatment:

Drug: Obeticholic acid

Drug: Bezafibrate 400 MG

Drug: Bezafibrate 200 mg Placebo

Long-term safety extension (LTSE) phase: OCA + BZF

Experimental group

Description:

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.

Treatment:

Drug: OCA

Drug: Bezafibrate