A Study to Assess the Efficacy and Safety of Apremilast in Japanese Pediatric Participants With Moderate to Severe Plaque Psoriasis
- Conditions
- Pediatric plaque psoriasis
- Registration Number
- JPRN-jRCT2031220486
- Lead Sponsor
- Kimura Takeshi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 33
1. Japanese participants aged 6 to 17 years at screening
2. Participants must have a weight of >= 15 kg
3. Diagnosis of chronic plaque psoriasis for at least 3 months prior to screening
4. Has moderate to severe plaque psoriasis at screening and baseline as defined by:
- PASI score >= 12; and
- BSA >= 10; and
- sPGA >= 3 (moderate to severe)
5. Disease inadequately controlled by or contraindicated for >= 1 topical therapy for psoriasis
6. Candidate for systemic therapy or phototherapy
1. Psoriasis flare or rebound within 4 weeks prior to screening
2. Evidence of skin conditions, other than psoriasis, that would interfere with clinical assessments
3. Other than psoriasis, history of any clinically significant (as determined by the investigator) cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic disease, or other major uncontrolled disease
4. Prior history of suicide attempt at any time in the participant's lifetime prior to screening or baseline in the study, or major psychiatric illness requiring hospitalization within 3 years prior to signing the assent and informed consent
5. Guttate, erythrodermic, or pustular psoriasis at screening and baseline
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. 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 ]
- Secondary Outcome Measures
Name Time Method