The study has been designed with three components. Part A is an open label PK study followed by a randomized trial component (Part B) followed by open label Long Term Extension (LTE). The initial PK analysis is first done in adolescent subjects (12 to \<18 years) before initiating the PK study in younger cohort (6 to \<12 years)
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Part A - Dose determination for pediatrics population 12 to <18-year-old age group
Timeframe: Up to week 16
Part A - Dose determination for pediatrics population 6 to <12 year-old age group
Timeframe: Up to week 16
Proportion of subjects with at least 75% improvement in the PASI response from baseline
Timeframe: Week 16
Proportion of subjects with PGA score of "clear" or "minimal" with at least a 2-grade reduction from baseline
Timeframe: Week 16
Number of subjects with adverse events
Timeframe: Week 16