Multicenter, Double-Blind, Randomized, Active- and Placebo Controlled Study to Evaluate Safety, Tolerability, and Efficacy of Ixekizumab in Patients from 6 to Less than 18 Years of Age with Moderate-to-Severe Plaque Psoriasis

INTERVENTION: Trade Name: Taltz 80 mg solution for injection in pre‐filled syringe. Pharmaceutical Form: Solution for injection in pre‐filled syringe INN or Proposed INN: IXEKIZUMAB Other descriptive name: LY2439821 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 80‐ Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use Trade Name: Enbrel Pharmaceutical Form: Solution for injection INN or Proposed INN: ETANERCEPT CAS Number: 185243‐69‐0 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 25‐ Trade Name: Enbrel Pharmaceutical Form: Solution for injection INN or Proposed INN: ETANERCEPT CAS Number: 185243‐69‐0 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 50‐ CONDITION: Moderate‐to‐Severe Plaque Psoriasis ; MedDRA version: 20.0 Level: LLT Classification code 10071117 Term: Plaque psoriasis System Organ Class: 100000004858 Therapeutic area: Diseases [C] ‐ Skin and Connective Tissue Diseases [C17] PRIMARY OUTCOME: Main Objective: To assess whether ixekizumab Q4W is superior to placebo at Week 12 (Visit 7) in the treatment of pediatric subjects (children and adolescents) with moderate‐to‐severe plaque psoriasis, as measured by PASI 75 and by sPGA (0,1) Primary end point(s): Proportion of subjects achieving PASI 75.; Proportion of subjects achieving sPGA (0,1). ; Secondary Objective: To assess whether ixekizumab Q4W is superior to placebo at Week 12 as measured by: PASI 90, sPGA (0), PASI 100, and Itch NRS.; Timepoint(s) of evaluation of this end point: Week 12. SECONDARY OUTCOME: Secondary end point(s): Proportion of subjects achieving PASI 90. ; Proportion of subjects achieving sPGA (0). ; Proportion of subjects achieving PASI 100. ; Proportion of subjects achieving PASI 75. ; Proportion of subjects achieving sPGA (0,1). ; Improvement =4 for subjects who had a baseline Itch NRS score =4. ; Timepoint(s) of evaluation of this end point: PASI 75 and sPGA 0,1 are measured at Week 2. All the others at Week 12 INCLUSION CRITERIA: Males and females from 6 years to <18 years of age. Have a diagnosis of moderate‐to‐severe plaque‐type Ps for at least 6 months prior to baseline (Week 0; Visit 2), as determined by the investigator. Have PASI score =12 and a sPGA =3 and body area involved =10% of whole body surface at screening (Visit 1) and baseline (Week 0; Visit 2). Are candidates for phototherapy or systemic treatment of Ps (may be either naive or have a prior history of previous treatment) or have Ps considered by the investigator as poorly controlled with topical therapy. Are the trial subjects under 18? yes Number of subjects for this age range: 195 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