NCT03997786

A Study of Tildrakizumab in Pediatric Subjects With Chronic Plaque Psoriasis

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

• Status: Active Not Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 135 (actual)
• Sponsor: Sun Pharmaceutical Industries Limited · Industry
• Sex: All
• Age: 6 Years – 215 Months
• Healthy volunteers: Not accepted

Summary

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)

Conditions

• Moderate-to-severe Chronic Plaque Psoriasis

Interventions

Type	Name	Description
DRUG	Tildrakizumab	Week 0 (Day 1), Week 4 (Day 28) and week 16 (Day 112)
DRUG	Placebo	(Weeks 0 to 16)
DRUG	Tildrakizumab	(Weeks 16 to 52)
DRUG	Tildrakizumab	at every 12 weeks in open label fashion till 5 years (240 weeks).
DRUG	Tildrakizumab	(Weeks 0 to 16)
DRUG	Etanercept	(Weeks 0 to 16)
DRUG	Placebo	(Weeks 16 to 52)

Timeline

• Start date: 2020-01-15
• Primary completion: 2025-04-07
• Completion: 2031-08-05
• First posted: 2019-06-25
• Last updated: 2026-04-15

Locations

27 sites across 6 countries: United States, Hungary, India, Poland, Slovakia, Spain

Regulatory

• FDA-regulated drug study