The primary objective of this study is to evaluate the efficacy of apremilast in children and adolescents (ages 6 through 17 years) with moderate to severe plaque psoriasis.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
17
Oral tablets
Achievement of a static Physician Global Assessment (sPGA) score of clear (0) or almost clear (1) with at least 2 points reduction from baseline at Week 16
Time frame: Week 16
Achievement of at least 75% reduction in Psoriasis Area and Severity Index (PASI) score (PASI-75) from baseline at Week 16
Time frame: Baseline, Week 16
Achievement of at least a 50% reduction in PASI score (PASI-50) from baseline at Week 16
Time frame: Baseline, Week 16
Percent change from baseline in total PASI score at Week 16
Time frame: Baseline, Week 16
Percent change from baseline in affected body surface area (BSA) at Week 16
Time frame: Baseline, Week 16
Achievement of Children Dermatology Life Quality Index (CDLQI) (0/1) at Week 16
Time frame: Week 16
Change from baseline in CDLQI score at Week 16
Time frame: Baseline, Week 16
Number of participants with treatment-emergent adverse events
Time frame: Approximately 52 weeks
Number of participants with clinically significant changes in vital signs
Time frame: Approximately 62 weeks
Number of participants with clinically significant changes in laboratory abnormalities
Time frame: Approximately 62 weeks
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Hokkaido University Hospital
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...and 19 more locations