A Study of Tildrakizumab in Pediatric Subjects With Chronic Plaque Psoriasis

The study has been designed with two components. Part A is an open label PK study followed by a randomized trial component (Part B). 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)


Study Type: Interventional  (Clinical Trial)
Estimated Enrollment: 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: The study will follow a two-component study design such that Part A will be an open label PK lead-in cohort of approximately 20 subjects. Part B will be a randomized trial component with approximately 100 subjects
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Placebo and Active Comparator-controlled Clinical Trial to Study the Efficacy, Safety and Pharmacokinetics (PK) of Tildrakizumab in Pediatric Subjects From 6 to <18 Years of Age With Moderate to Severe Chronic Plaque Psoriasis
Estimated Study Start Date: October 15, 2019
Estimated Primary Completion Date: November 1, 2023
Estimated Study Completion Date: November 1, 2023

Arms:
- Placebo Comparator: Part B - Placebo
- Active Comparator: Part B - Etanercept
- Experimental: Tildrakizumab