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

Recruiting in Palo Alto (17 mi)

+9 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Janssen Research & Development, LLC

Prior Safety Data

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Research Team

Janssen Research & Development, LLC Clinical Trial

Principal Investigator

Janssen Research & Development, LLC

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)

Treatment Details

Interventions

• Ustekinumab (Monoclonal Antibodies)

Participant Groups

Group I: Open-label: ustekinumab 90 mg Experimental Treatment 1 Intervention

Group II: Double-blind: ustekinumb 180 mg Experimental Treatment 1 Intervention

Group III: Double-blind: ustekinumab 90 mg Experimental Treatment 1 Intervention

Group IV: Double-blind: ustekinumab 45 mg Experimental Treatment 1 Intervention

Group V: Double-blind: placebo Placebo Group 1 Intervention

Ustekinumab is already approved in Canada, Japan for the following indications:

Approved in Canada as Stelara for:

• Moderate to severe plaque psoriasis
• Active psoriatic arthritis
• Moderately to severely active Crohn's disease
• Moderately to severely active ulcerative colitis

Approved in Japan as Stelara for:

• Plaque psoriasis
• Psoriatic arthritis
• Crohn's disease
• Ulcerative colitis

Who Is Running the Clinical Trial?

Janssen Research & Development, LLC

Lead Sponsor

Trials

1,022

Recruited

6,408,000+

Giacomo Salvadore

Janssen Research & Development, LLC

Chief Medical Officer since 2023

MD from the University of Rome, Tor Vergata

Ricardo Attar

Janssen Research & Development, LLC

Chief Executive Officer since 2008

PhD in Molecular Biology from the University of Buenos Aires