Phase 2
N=20
A Study of Efficacy and Safety of Ustekinumab in Patients With Primary Biliary Cirrhosis (PBC) Who Had an Inadequate Response to Ursodeoxycholic Acid
Primary Biliary Cirrhosis
Bottom Line
View on ClinicalTrials.gov: NCT01389973 ↗Enrolled (actual)
20
Serious AEs
5.0%
Results posted
Oct 2014
Primary outcome: Primary: Part 1: Number of Participants With Alkaline Phosphatase (ALP) Response at Week 12 — 0 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- ustekinumab 90 mg (Drug); ustekinumab 45 mg (Drug); ustekinumab 180 mg (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Janssen Research & Development, LLC
- Primary completion
- Jun 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Part 1: Number of Participants With Alkaline Phosphatase (ALP) Response at Week 12 |
— | — |
| SECONDARY Part 1: Number of Participants With ALP Response at Week 28 |
— | — |
| SECONDARY Part 1: Number of Participants With ALP Remission at Week 28 |
— | — |
| SECONDARY Part 1: Percent Change From Baseline in ALP Concentration at Week 28 |
-11.25 | — |
| SECONDARY Part 1: Percent Change From Baseline in Alanine Aminotransferase, Aspartate Aminotransferase, and Bilirubin Concentration at Week 28 |
-9.21; -7.22; -4.61 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01389973). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.