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

Conditions

• Primary Biliary Cirrhosis

Eligibility Criteria

Sex

ALL

Age

18 Years - 99 Years

Healthy Volunteers

Not accepted

Interventions

• ustekinumab 90 mg — DRUG
  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.
• ustekinumab 45 mg — DRUG
  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.
• ustekinumab 180 mg — DRUG
  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.
• Placebo — DRUG
  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.

Study Details

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.

Key Dates

Start date

Sep 30, 2011

Status verified

Jun 2016

Primary completion

Jun 30, 2013

Completion

Jun 30, 2013

Study Design

Enrollment

20 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Open-label: ustekinumab 90 mg
• Experimental: Double-blind: ustekinumab 45 mg
• Experimental: Double-blind: ustekinumab 90 mg
• Experimental: Double-blind: ustekinumb 180 mg
• Placebo Comparator: Double-blind: placebo

Primary Outcome Measure

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

Locations (6)

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