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A Study of Tildrakizumab in Pediatric Subjects With Chronic Plaque Psoriasis
Sponsor: Sun Pharmaceutical Industries Limited
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
Tildrakizumab
Week 0 (Day 1), Week 4 (Day 28) and week 16 (Day 112)
Placebo
(Weeks 0 to 16)
Tildrakizumab
(Weeks 16 to 52)
Tildrakizumab
at every 12 weeks in open label fashion till 5 years (240 weeks).
Tildrakizumab
(Weeks 0 to 16)
Etanercept
(Weeks 0 to 16)
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