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
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of ustekinumab in pediatric
      participants aged greater than or equal to (>=) 6 through less than (<) 12 years with
      moderate to severe chronic plaque psoriasis
    

Detailed description: 
      This is an open label (identity of study drug will be known to participant and study staff)
      and multicenter (when more than one hospital or medical school team work on a medical
      research study) study. The participant population will be comprised of boys and girls who
      have had a diagnosis of plaque psoriasis for at least 6 months prior to first study drug
      administration and who have moderate to severe disease defined by Psoriasis Area and Severity
      Index score (PASI) >=12, Physician's Global Assessment (PGA) >=3, and Body Surface Area (BSA)
      >=10 percent (%). The study consists of Screening Phase (up to 10 weeks before administration
      of the study drug), Treatment Period (Week 0 up to Week 52) and Safety follow up (Week 56).
      Participants will be primarily evaluated for efficacy, pharmacokinetics (PK) and safety.
      Following completion of the Week 52 visit, participants who have had a beneficial response
      from ustekinumab treatment as determined by the investigator, and who have not yet reached
      the age of 12 years or older in countries where marketing authorization for ustekinumab has
      been granted for the treatment of psoriasis in adolescent participants (12-17 years), and are
      willing to continue ustekinumab treatment, may enter the long-term extension period (from
      Week 56 through Week 264) of the study.
    

Intervention name(s): Ustekinumab 0.75 mg/kg; Ustekinumab 45 mg; Ustekinumab 90 mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 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.; 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.; 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.
Intervention MeSH terms: Ustekinumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Psoriasis; Ustekinumab; STELARA