This is a study of the safety and efficiacy of ustekinumab (CNTO1275) in adolescent patients with moderate to severe psoriasis

INTERVENTION: Trade Name: STELARA Pharmaceutical Form: Solution for injection INN or Proposed INN: Ustekinumab CAS Number: 815610‐63‐0 Current Sponsor code: CNTO1275 Other descriptive name: Human anti‐IL‐12/23 monoclonal antibody Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 90‐ Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use CONDITION: Moderate to Severe Plaque‐type Psoriasis ; MedDRA version: 14.1 Level: PT Classification code 10037153 Term: Psoriasis System Organ Class: 10040785 ‐ Skin and subcutaneous tissue disorders Therapeutic area: Diseases [C] ‐ Skin and Connective Tissue Diseases [C17] PRIMARY OUTCOME: Main Objective: The primary objectives of this study are to evaluate the efficacy and safety of 2 SC dosing tiers of ustekinumab in the treatment of adolescent subjects = 12 to < 18 years of age with moderate to severe chronic plaque psoriasis. Primary end point(s): Proportion of patients who achieve a Physician's Global Assessment (PGA) score of cleared or minimal disease Secondary Objective: The secondary objectives of this study are to:; ; 1. Evaluate the impact of ustekinumab on physical, social, emotional, and academic functioning as well as dermatologic symptom impact on health‐related quality of life in adolescent subjects with moderate to severe chronic plaque psoriasis.; ; 2. Evaluate the pharmacokinetics and immunogenicity of ustekinumab in adolescent subjects with moderate to severe chronic plaque psoriasis. Timepoint(s) of evaluation of this end point: week 12 SECONDARY OUTCOME: Secondary end point(s): Proportion of patients that achieve Psoriasis Area and Severity Index (PASI) 75 response ; ; Change from baseline in Children's Dermatology Life Quality Index ; (CDLQI) ; ; The proportion of patients who achieve a Psoriasis Area and Severity Index (PASI) 90 response Timepoint(s) of evaluation of this end point: week 12 INCLUSION CRITERIA: Adolescent subjects = 12 to < 18 years of age who have a diagnosis of plaque‐type psoriasis with or without psoriatic arthritis (PsA) for at least 6 months; Are candidates for phototherapy or systemic treatment of psoriasis; Have screening laboratory test results within the study parameters. Are the trial subjects under 18? yes Number of subjects for this age range: 150 F.1.2 Adults (18‐64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range