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

Sponsor ID
20200346
Clinicaltrials.gov ID
NCT05565560
EUCTIS ID
N/A
EudraCT ID
N/A

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.

Additional Study Details

Phase
Phase 3
Product
Otezla
Type
Interventional
Masking
None (Open Label)
Enrollment
17
Additional Study Details

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
Status
Contact Us
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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