Efficacy and safety of bezafibrate 400 mg and bezafibrate 200 mg as adjunctive treatments in patients with primary biliary cholangitis and non-optimal biochemical response to ursodeoxycholic acid therapy: a 12-month, double-blind, randomized, placebo-controlled trial with a 12-month, double-blind, placebo-free extension phase - BEZURSO 2

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-504086-23-00

Acronym

APHP220822

Enrollment

130

Registered

2024-09-03

Start date

2025-03-27

Completion date

Unknown

Last updated

2025-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Subjects with PBC with a non-optimal response to UDCA.

Brief summary

• Proportion of patients with a complete biochemical response defined by normal serum levels of alkaline phosphatase (ALP), gamma-glutamyl transpeptidase (GGT), aminotransferases (AST, ALT), and total bilirubin at 48 weeks of treatment.

Detailed description

1. Changes from baseline to W48 in itch intensity mean of the last 24h assessed by NRS as recommended by IFSI SIG / EADV Task Force Pruritus., 2. Proportion of patients with normal levels of ALP at W48., 3. Changes from baseline to W48 in LSM assessed by Fibroscan.

Interventions

DRUGBEFIZAL 200 mg

DRUGcomprimé pelliculé

DRUGPlacebo BEZAFIBRATE 200 mg

DRUGBEFIZAL L.P. 400 mg

DRUGcomprimé enrobé à libération prolongée

DRUGBEZAFIBRATE LP 400 mg

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
• Proportion of patients with a complete biochemical response defined by normal serum levels of alkaline phosphatase (ALP), gamma-glutamyl transpeptidase (GGT), aminotransferases (AST, ALT), and total bilirubin at 48 weeks of treatment.	—

Secondary

Measure	Time frame
1. Changes from baseline to W48 in itch intensity mean of the last 24h assessed by NRS as recommended by IFSI SIG / EADV Task Force Pruritus., 2. Proportion of patients with normal levels of ALP at W48., 3. Changes from baseline to W48 in LSM assessed by Fibroscan.	—

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026