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NCT05565560
A Study to Assess the Efficacy and Safety of Apremilast in Japanese Pediatric Participants With Moderate to Severe Plaque Psoriasis
Conditions: Plaque Psoriasis
Sex: All
Ages: 6 Years – 17 Years
Healthy volunteers: No
Phase: PHASE3
Enrollment: 17
Sponsor: Amgen
Location: Nagoya City University Hospital Nagoya Aichi-ken
Summary
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.
Eligibility Criteria
Inclusion Criteria:
* Japanese participants aged 6 to 17 years at screening
* Participants must have a weight of ≥ 15 kg
* Diagnosis of chronic plaque psoriasis for at least 3 months prior to screening
* 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)
* Disease inadequately controlled by or contraindicated for ≥ 1 topical therapy for psoriasis
* Candidate for systemic therapy or phototherapy
Exclusion Criteria:
* Psoriasis flare or rebound within 4 weeks prior to screening
* Evidence of skin conditions, other than psoriasis, that would interfere with clinical assessments
* 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
* 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
* Guttate, erythrodermic, or pustular psoriasis at screening and baseline
Source: ClinicalTrials.gov (NCT05565560). StuddyBuddy aggregates publicly available trial information.