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)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
130
Week 0 (Day 1), Week 4 (Day 28) and week 16 (Day 112)
(Weeks 0 to 16)
(Weeks 16 to 52)
Part A - Maximum Plasma Concentration
Time frame: Day 3, 7 and 28 following first dose
Part A - Area under the plasma concentration-time curve
Time frame: Day 3, 7 and 28 following first dose
Part A - Maximum Plasma Concentration
Time frame: Weeks 4,8, and 12 following second dose
Part A - Area under the plasma concentration-time curve
Time frame: Weeks 4,8, and 12 following second dose
Proportion of subjects with at least 75% improvement in the PASI response from baseline
Time frame: Week 12
Proportion of subjects with PGA of "clear" or "almost clear" with at least a 2 grade reduction from baseline
Time frame: Week 12
Number of subjects with adverse events
Time frame: Week 52
Proportion of subjects achieving Psoriasis Area & Severity Index (PASI) 50 from baseline
Time frame: Week 12, 16, 28, 40, 52, 64, 76 and 88
Proportion of subjects achieving Psoriasis Area & Severity Index (PASI) 90 from baseline
Time frame: Week 12, 16, 28, 40, 52, 64, 76 and 88
Proportion of subjects achieving Psoriasis Area & Severity Index (PASI) 100 from baseline
Time frame: Week 12, 16, 28, 40, 52, 64, 76 and 88
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at every 12 weeks in open label fashion till 5 years (240 weeks).
(Weeks 0 to 16)
(Weeks 0 to 16)
(Weeks 16 to 52)
Site 23
Birmingham, Alabama, United States
WITHDRAWNSite 1
Fountain Valley, California, United States
RECRUITINGSite 2
Thousand Oaks, California, United States
COMPLETEDSite 4
Clearwater, Florida, United States
WITHDRAWNSite 24
Coral Gables, Florida, United States
WITHDRAWNSite 20
Miami, Florida, United States
COMPLETEDSite 7
Miami, Florida, United States
RECRUITINGSite 12
Orlando, Florida, United States
WITHDRAWNSite 5
Bay City, Michigan, United States
WITHDRAWNSite 16
Troy, Michigan, United States
WITHDRAWN...and 40 more locations
Proportion of subjects achieving PASI 75 and PGA score of "clear" or "almost clear" with at least a 2 grade reduction from baseline
Time frame: Week 16, 28, 40, 52, 64, 76 and 88
Change in quality of life as measured by Children's Dermatology Life Quality Index (CDLQI)
The CDLQI is a 10-item questionnaire that measures the impact of skin disease on children's (aged 2-15 years) quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The CDLQI total score was the sum of individual scores of question 1-10 and ranges from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the children's life; 2-6 = small effect on the children's life; 7-12 = moderate effect on the children's life; 13-18 = very large effect on the children's life; 19-30 = extremely large effect on the children's life. Higher scores indicate more impact on quality of life of children.
Time frame: Week 108
Number of subjects with Adverse events
Time frame: Week 108
Immunogenicity - Anti-drug antibody status
Time frame: Week 108
Percent of subjects with severe infections
defined as any infection meeting the regulatory definition of a serious adverse event, or any infection requiring IV antibiotics whether or not reported as a serious event as per the regulatory definition
Time frame: Week 108
Percent of subjects with malignancies
including non-melanoma and melanoma skin cancer, but excluding carcinoma in situ of the cervix
Time frame: Week 108
Percent of subjects with confirmed major adverse cardiovascular events
major adverse cardiovascular events
Time frame: Week 108
Percent of subjects with drug- related hypersensitivity reactions
e.g. anaphylaxis, urticarial, angioedema, etc
Time frame: Week 108