A Study of Efficacy and Safety of Ustekinumab in Patients With Primary Biliary Cirrhosis (PBC) Who Had an Inadequate Response to Ursodeoxycholic Acid
Condition: Primary Biliary Cirrhosis
MeSH terms: Liver Cirrhosis; Liver Cirrhosis, Biliary; Fibrosis
Intervention: ustekinumab 90 mg; ustekinumab 45 mg; ustekinumab 180 mg; Placebo
Intervention description: Subcutaneous injections of ustekinumb 90 mg at Weeks 0 and 4 and every 8 weeks until the dose for the Long-Term Extension has been selected then every 8 weeks through Week 196 with the selected dose.; Subcutaneous injections of ustekinumb 45 mg at Weeks 0 and 4 and every 8 weeks until the dose for the Long-Term Extension has been selected then every 8 weeks through Week 196 with the selected dose.; Subcutaneous injections of ustekinumb 180 mg at Weeks 0 and 4 and every 8 weeks until the dose for the Long-Term Extension has been selected then every 8 weeks through Week 196 with the selected dose.; Subcutaneous injections of placebo at Weeks 0 and 4 and every 8 weeks until the dose for the Long-Term Extension has been selected then every 8 weeks through Week 196 with the selected dose.
Intervention MeSH terms: Ustekinumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: Diseases [C] - Digestive System Diseases [C06]; primary biliary cirrhosis; ursodeoxycholic acid (UDCA); STELARA; ustekinumab

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.