Recruitment Complete
Sponsor ID
20200346
A Study to Assess the Efficacy and Safety of Apremilast in Japanese Pediatric Participants With Moderate to Severe Plaque Psoriasis
Study Details
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.
Protocol Summary
Primary Outcome Measures
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
Timeframe: Week 16
Secondary Outcome Measures
Achievement of at least 75% reduction in Psoriasis Area and Severity Index (PASI) score (PASI-75) from baseline at Week 16
Timeframe: Baseline, Week 16
Achievement of at least a 50% reduction in PASI score (PASI-50) from baseline at Week 16
Timeframe: Baseline, Week 16
Percent change from baseline in total PASI score at Week 16
Timeframe: Baseline, Week 16
Percent change from baseline in affected body surface area (BSA) at Week 16
Timeframe: Baseline, Week 16
Achievement of Children Dermatology Life Quality Index (CDLQI) (0/1) at Week 16
Timeframe: Week 16
Change from baseline in CDLQI score at Week 16
Timeframe: Baseline, Week 16
Number of participants with treatment-emergent adverse events
Timeframe: Approximately 52 weeks
Number of participants with clinically significant changes in vital signs
Timeframe: Approximately 62 weeks
Number of participants with clinically significant changes in laboratory abnormalities
Timeframe: Approximately 62 weeks
Locations
Location
Takagi Dermatological Clinic
Obihiro-shi, Hokkaido, Japan, 080-0013
Status
Recruiting
Location
Shinshu University Hospital
Matsumoto-shi, Nagano, Japan, 390-8621
Status
Recruiting
Location
Takeoka Dermatology Clinic
Marugame-shi, Kagawa, Japan, 763-0074
Status
Recruiting
Location
Sugai Dermatology Park Side Clinic
Utsunomiya-shi, Tochigi, Japan, 321-0954
Status
Recruiting
Location
Fukushima Medical University Hospital
Fukushima-shi, Fukushima, Japan, 960-1295
Status
Recruiting
Location
St Lukes International Hospital
Chuo-ku, Tokyo, Japan, 104-8560
Status
Recruiting
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