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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT01389973
• Date of registration: 07/07/2011
• Prospective Registration: Yes
• Primary sponsor: Janssen Research & Development, LLC
• Public title: A Study of Efficacy and Safety of Ustekinumab in Patients With Primary Biliary Cirrhosis (PBC) Who Had an Inadequate Response to Ursodeoxycholic Acid
• Scientific title: A Phase 2, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Evaluating the Efficacy and Safety of Ustekinumab in Subjects With Primary Biliary Cirrhosis Who Had an Inadequate Response to Ursodeoxycholic Acid (UDCA)
• Date of first enrolment: September 2011
• Target sample size: 20
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01389973
• Study type: Interventional
• Phase: Phase 2

Countries of recruitment

Canada, United States

Contacts

• Name: Janssen Research & Development, LLC Clinical Trial
• Affiliation: Janssen Research & Development, LLC

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 99 Years
Gender: All

Health Condition(s) or Problem(s) studied

Primary Biliary Cirrhosis

Intervention(s)

Drug: ustekinumab 180 mg

Drug: Placebo

Drug: ustekinumab 90 mg

Drug: ustekinumab 45 mg

Primary Outcome(s)

Part 1: Number of Participants With Alkaline Phosphatase (ALP) Response at Week 12 [Time Frame: Week 12]

Secondary Outcome(s)

Part 1: Number of Participants With ALP Remission at Week 28 [Time Frame: Week 28]

Part 1: Number of Participants With ALP Response at Week 28 [Time Frame: Week 28]

Part 1: Percent Change From Baseline in Alanine Aminotransferase, Aspartate Aminotransferase, and Bilirubin Concentration at Week 28 [Time Frame: Baseline and Week 28]

Part 1: Percent Change From Baseline in ALP Concentration at Week 28 [Time Frame: Baseline and Week 28]

Secondary ID(s)

2011-000554-31

CNTO1275PBC2001

CR018748

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 15/10/2014
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01389973