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
Intervention: Ustekinumab 0.75 mg/kg; Ustekinumab 45 mg; Ustekinumab 90 mg
Intervention description: 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
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 44.0
Sex: All
Minimum age: 6 Years
Maximum age: 11 Years
Healthy volunteers: No
Keywords: Psoriasis; Ustekinumab; STELARA

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
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants who have a diagnosis of plaque-type psoriasis with or without psoriatic
             arthritis (PsA) for at least 6 months prior to first administration of study drug,
             with widespread lesions defined by Psoriasis Area and Severity Index score (PASI)
             greater than or equal to (>=) 12, Physician's Global Assessment (PGA) >=3, and
             involved body surface area (BSA) >=10 percent (%)

          -  Participants who are candidates for phototherapy or systemic treatment of psoriasis
             (either naive or history of previous treatment) or have psoriasis considered by the
             investigator as poorly controlled with topical therapy after an adequate dose and
             duration of therapy

          -  Participants who are considered eligible according to the protocol defined
             tuberculosis (TB) screening criteria

          -  Participants must have positive protective antibody titers to varicella and measles
             prior to the first administration of study drug. In the absence of positive protective
             antibody titers, the participant must have documentation of age-appropriate
             vaccination for varicella and/or measles (that includes both doses of each vaccine) or
             verification of past varicella and/or measles infection documented by a health care
             provider

          -  Participants must agree not to receive a live virus or live bacterial vaccination at
             least 2 weeks (or longer as indicated in the package insert of the relevant vaccine)
             prior to the first administration of study drug, during the study, or within 15 weeks
             after the last administration of study drug

          -  Participants must agree not to receive a Bacille Calmette-Guerin (BCG) vaccination
             within 12 months of screening, during the study, or within 12 months after the last
             administration of study drug

        Exclusion Criteria:

          -  Participants who currently have nonplaque forms of psoriasis (example, erythrodermic,
             guttate, or pustular)

          -  Have received any systemic immunosuppressants (example methotrexate [MTX],
             azathioprine, cyclosporine, 6-thioguanine, mercaptopurine, mycophenolate mofetil,
             hydroxyurea, and tacrolimus) within 4 weeks of the first administration of study drug

          -  Have received any biologic agent (example ENBREL, HUMIRA) within the previous 3 months
             or 5 times the t1/2 of the agent, whichever is longer

          -  Have a history of chronic or recurrent infectious disease

          -  Have a history of latent or active granulomatous infection

          -  Have any known malignancy or have a history of malignancy

          -  Have a known history of lymphoproliferative disease, including lymphoma, or signs and
             symptoms suggestive of possible lymphoproliferative disease