NCT01389973 - A Study of Efficacy and Safety of Ustekinumab in Patients With Primary Biliary Cirrhosis (PBC) Who Had an Inadequate Response to Ursodeoxycholic Acid | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

September 30, 2011

Primary Completion Date

June 30, 2013

Study Completion Date

June 30, 2013

Conditions

Primary Biliary Cirrhosis

Interventions

DRUG

ustekinumab 90 mg

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.

DRUG

ustekinumab 45 mg

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.

DRUG

ustekinumab 180 mg

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.

DRUG

Placebo

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.

Trial Locations (10)

Unknown

Jacksonville

Miami

Naples

Tupelo

New York

Houston

Vancouver

Halifax

Toronto

Montreal

All Listed Sponsors

lead

Janssen Research & Development, LLC

INDUSTRY