An Efficacy, Safety, and Pharmacokinetics Study of Subcutaneously Administered Ustekinumab in the Treatment of Moderate to Severe Chronic Plaque Psoriasis in Pediatric Participants Greater Than or Equal to 6 to Less Than 12 Years of Age

PHASE3CompletedINTERVENTIONAL
Enrollment

44

Participants

Timeline

Start Date

May 31, 2016

Primary Completion Date

December 31, 2017

Study Completion Date

October 31, 2020

Conditions
Psoriasis
Interventions
DRUG

Ustekinumab 0.75 mg/kg

Participants weighing less than (\<) 60 kilograms will receive ustekinumab 0.75 milligram per kilogram (mg/kg) at Weeks 0 and 4 followed by every 12 weeks dosing with the last dose at Week 40. Eligible participants for LTE period will continue to receive ustekinumab 0.75 mg/kg up to Week 248.

DRUG

Ustekinumab 45 mg

Participants weighing greater than or equal to (\>=) 60 kg to less than or equal to (\<=) 100 kg will receive ustekinumab 45 mg at Weeks 0 and 4 followed by every 12 weeks dosing with the last dose at Week 40. Eligible participants for LTE period will continue to receive ustekinumab 45 mg up to Week 248.

DRUG

Ustekinumab 90 mg

Participants weighing \>100 kg will receive ustekinumab 90 mg at Weeks 0 and 4 followed by every 12 weeks dosing with the last dose at Week 40. Eligible participants for LTE period will continue to receive ustekinumab 90 mg up to Week 248.

Trial Locations (31)

Unknown

San Diego

Chicago

Indianapolis

St Louis

Arlington

Dallas

Norfolk

Brussels

Ghent

Liège

Calgary

St. John's

Berlin

Bonn

Dresden

Frankfurt

Budapest

Debrecen

Kaposvár

Kecskemét

Szeged

Nijmegen

Lodz

Warsaw

Wroclaw

Bundang

Incheon

Seoul

Kaohsiung City

Taipei

Taoyuan District

All Listed Sponsors
lead

Janssen Research & Development, LLC

INDUSTRY

NCT02698475 - An Efficacy, Safety, and Pharmacokinetics Study of Subcutaneously Administered Ustekinumab in the Treatment of Moderate to Severe Chronic Plaque Psoriasis in Pediatric Participants Greater Than or Equal to 6 to Less Than 12 Years of Age | Biotech Hunter | Biotech Hunter