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
Who is this study for? Pediatric patients with moderate-to-severe chronic plaque psoriasis
Status: Recruiting
Location: See all (50) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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)
Eligibility
Participation Requirements
Sex: All
Minimum Age: 6
Maximum Age: 17
Healthy Volunteers: f
View:
• Subject must be 6 to \< 18 years of age, of either sex, of any race/ ethnicity, must weight greater than or equal to 15Kg.
• Diagnosis of predominantly plaque psoriasis for ≥6 months (as determined by subject interview and confirmation of diagnosis through physical examination by investigator).
• Moderate to severe psoriasis at baseline defined as: at least 10% Body Surface Area (BSA) involvement, PGA score ≥ 3, and PASI score ≥ 12
• Subject must be considered a candidate for systemic therapy, meaning psoriasis inadequately controlled by topical treatments (corticosteroids), and/or phototherapy, and/or previous systemic therapy
• Subject is considered to be eligible according to tuberculosis (TB) screening criteria
• A maximum of 2 QuantiFERON tests will be allowed. A re-test is only permitted if the first is indeterminate; the result of the second test will then be used.
Locations
United States
Alabama
Site 23
WITHDRAWN
Birmingham
California
Site 1
RECRUITING
Fountain Valley
Site 2
COMPLETED
Thousand Oaks
Florida
Site 4
WITHDRAWN
Clearwater
Site 24
WITHDRAWN
Coral Gables
Site 20
COMPLETED
Miami
Site 7
RECRUITING
Miami
Site 12
WITHDRAWN
Orlando
Michigan
Site 5
WITHDRAWN
Bay City
Site 16
WITHDRAWN
Troy
Missouri
Site 22
WITHDRAWN
Saint Joseph
Texas
Site 8
WITHDRAWN
Dallas
Utah
Site 10
WITHDRAWN
South Jordan
Washington
Site 14
COMPLETED
Spokane
Other Locations
Hungary
Site 62
RECRUITING
Budapest
Site 63
NOT_YET_RECRUITING
Budapest
Site 61
RECRUITING
Debrecen
Site 64
RECRUITING
Kaposvár
Site 28
WITHDRAWN
Szeged
India
Site 70
NOT_YET_RECRUITING
Ahmedabad
Site 79
RECRUITING
Ahmedabad
Site 78
NOT_YET_RECRUITING
Chennai
Site 75
WITHDRAWN
Kolkata
Site 76
WITHDRAWN
Kolkata
Site 71
RECRUITING
Lucknow
Site 73
WITHDRAWN
Pune
Site 74
RECRUITING
Surat
Site 77
RECRUITING
Surat
Site 80
RECRUITING
Warangal
Poland
Site 57
RECRUITING
Bialystok
Site 55
NOT_YET_RECRUITING
Gdansk
Site 51
RECRUITING
Katowice
Site 54
RECRUITING
Lodz
Site 56
RECRUITING
Lodz
Site 58
RECRUITING
Lublin
Site 50
RECRUITING
Ostrowiec Świętokrzyski
Site 59
RECRUITING
Sosnowiec
Site 52
RECRUITING
Szczecin
Site 53
RECRUITING
Warsaw
Site 38
RECRUITING
Wroclaw
Site 39
RECRUITING
Wroclaw
Site 40
WITHDRAWN
Wroclaw
Slovakia
Site 92
RECRUITING
Bardejov
Site 91
RECRUITING
Svidník
Site 90
RECRUITING
Trnava
Spain
Site 41
NOT_YET_RECRUITING
Barcelona
Site 47
COMPLETED
Las Palmas De Gran Canaria
Site 42
WITHDRAWN
Madrid
Site 44
WITHDRAWN
Valencia
Site 45
WITHDRAWN
Valencia
Contact Information
Primary
Head, Clinical Development
Clinical.Trial@sunpharma.com
91 2266455645
Time Frame
Start Date:2020-01-15
Estimated Completion Date:2031-12-05
Participants
Target number of participants:130
Treatments
Active_comparator: Part A
Part A is a DOSE FINDING COMPONENT: OPEN LABEL PK lead-in and safety component
Experimental: Part B Part 1: Placebo and active comparator controlled study
Experimental: Part B-1 and B-2: Randomized withdrawal and retreatment after relapse
No_intervention: Part B 3: Efficacy and Safety Follow-up