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.