Overview

A Study of Efficacy and Safety of Ustekinumab in Patients With Primary Biliary Cirrhosis (PBC) Who Had an Inadequate Response to Ursodeoxycholic Acid

Status:
Completed
Trial end date:
2013-06-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to evaluate the efficacy and safety of ustekinumab in patients with primary biliary cirrhosis who had an inadequate response to ursodeoxycholic acid.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Janssen Research & Development, LLC
Treatments:
Ursodeoxycholic Acid
Ustekinumab
Criteria
Inclusion Criteria:

- Have proven or are likely to have Primary Biliary Cirrhosis (PBC)

- Be on a stable dose of ursodeoxycholic acid for at least 6 months prior to Week 0

- Have screening alkaline phosphatase (ALP) level > 1.67 ULN (the upper limit of normal)

- Have screening laboratory test results within protocol-specified limits

- Have no history of latent or active tuberculosis (TB) prior to screening and no signs
or symptoms suggestive of active TB upon medical history and/or physical examination.

Exclusion Criteria:

- Has history of gastrointestinal bleeding, secondary to portal hypertension, hepatic
encephalopathy, or ascites requiring treatment with diuretics

- Has a screening direct bilirubin > 1.0 mg/dL

- Has a previous liver histology with a diagnosis of steatohepatitis or has a high risk
of nonalcoholic steatohepatitis

- Has a previous liver histology with a diagnosis of chronic autoimmune hepatitis or has
a high risk of autoimmune hepatitis overlap syndrome

- Testing positive for surface antigen (HBsAg+), regardless of the results of other
hepatitis B tests

- Have used colchicine, methotrexate (MTX), azathioprine (AZA), or systemic
corticosteroids within 3 months prior to the first administration of study drug.