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ACTIVE NOT RECRUITING
NCT03997786
PHASE2/PHASE3

A Study of Tildrakizumab in Pediatric Subjects With Chronic Plaque Psoriasis

Sponsor: Sun Pharmaceutical Industries Limited

View on ClinicalTrials.gov

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)

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

Key Details

Gender

All

Age Range

6 Years - 215 Months

Study Type

INTERVENTIONAL

Enrollment

135

Start Date

2020-01-15

Completion Date

2031-08-05

Last Updated

2026-03-23

Healthy Volunteers

No

Interventions

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)

Locations (27)

Site 1

Fountain Valley, California, United States

Site 2

Thousand Oaks, California, United States

Site 20

Miami, Florida, United States

Site 7

Miami, Florida, United States

Site 14

Spokane, Washington, United States

Site 63

Budapest, Hungary

Site 62

Budapest, Hungary

Site 61

Debrecen, Hungary

Site 64

Kaposvár, Hungary

Site 79

Ahmedabad, India

Site 71

Lucknow, India

Site 74

Surat, India

Site 57

Bialystok, Poland

Site 51

Katowice, Poland

Site 54

Lodz, Poland

Site 56

Lodz, Poland

Site 58

Lublin, Poland

Site 50

Ostrowiec Świętokrzyski, Poland

Site 59

Sosnowiec, Poland

Site 52

Szczecin, Poland

Site 53

Warsaw, Poland

Site 39

Wroclaw, Poland

Site 92

Bardejov, Slovakia

Site 91

Svidník, Slovakia

Site 90

Trnava, Slovakia

Site 41

Barcelona, Spain

Site 47

Las Palmas de Gran Canaria, Spain