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

Phase 2 Completed 20 enrolled Janssen Research & Development, LLC

RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start: 2011-09
Primary completion: 2013-06
Completion: 2013-06

Publications

Mousa HS, Lleo A, Invernizzi P, Bowlus CL, Gershwin ME. Advances in pharmacotherapy for primary biliary cirrhosis. Expert Opin Pharmacother. 2015 Apr;16(5):633-43. doi: 10.1517/14656566.2015.998650. Epub 2014 Dec 29.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ustekinumab	Monoclonal antibody	45 mg	Subcutaneous
Subject	Ustekinumab	Monoclonal antibody	90 mg	Subcutaneous
Subject	Ustekinumab	Monoclonal antibody	180 mg	Subcutaneous

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

Summary

Timeline

Publications

Drugs

Indications