A Phase 2, Double-Blind, Randomized, Parallel-Group Study Evaluating the Efficacy, Safety, and Tolerability of Obeticholic Acid, Administered in Combination with Bezafibrate, in Subjects with Primary Biliary Cholangitis Who Had an Inadequate Response or Who Were Unable to Tolerate Ursodeoxycholic Acid

Phase 2

Recruiting

• Conditions: bile duct inflammation; Primary biliary cholangitis (PBC); 10017969

• Registration Number: NL-OMON54633
• Lead Sponsor: Intercept Pharmaceuticals, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 12

Inclusion Criteria

- A definite or probable diagnosis of PBC (consistent with the European
Association for the Study of the Liver [EASL] Practice Guidelines and the
American Association for the Study of Liver Diseases; [Lindor 2009a, EASL 2017])
- Qualifying ALP and / or bilirubin liver biochemistry values
- Age >=18 years
- Taking UDCA for at least 12 months (stable dose for >=3 months) before Day 1
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 decompensating events
- History of or current gallbladder diseases
- 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

Note: Other protocol defined Inclusion/Exclusion criteria may apply

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Absolute change in ALP from baseline to Week 12 in the DB treatment period.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary endpoints include:<br /><br>• The response rates of >=10%, >=20%, >=30%, and >=40% reduction from baseline and<br /><br>normalization rates of ALP at Week 12<br /><br>• Normalization rates at Week 12 of GGT, ALT, AST, ALP total and conjugated<br /><br>bilirubin, and a lipid panel<br /><br>• Change from baseline to Week 12 in GGT, ALT, AST, and total and conjugated<br /><br>bilirubin, and a lipid panel<br /><br>• Change from baseline to Week 12 in 7a-hydroxy-4-cholesten-3-one (C4) and bile<br /><br>acids</p><br>