Psoriasis Clinical Trial
A Study of Apremilast in Pediatric Participants in Children With Mild to Moderate Plaque Psoriasis
Summary
The primary objective of this post-marketing study is to assess the safety and tolerability of apremilast in pediatric participants (ages 6 through 17 years) with mild to moderate plaque psoriasis.
Eligibility Criteria
Inclusion Criteria:
Participants must have a weight of ≥ 20 kg.
Participant must have an age and sex specific BMI value no lower in range than the fifth percentile on the growth chart for children and adolescents.
Participant is able to swallow the study medication tablet.
Diagnosis of chronic plaque psoriasis for at least 6 months prior to screening.
Has mild to moderate plaque psoriasis at screening and Study Visit 1 as defined by:
Psoriasis Area Severity Index score 2-15,
Body surface area 2-15%, and
Static Physician Global Assessment score of 2-3 (mild to moderate)
Disease inadequately controlled by or inappropriate for topical therapy for psoriasis.
Exclusion Criteria:
Guttate, erythrodermic, or pustular psoriasis at screening and Study Day 1.
Psoriasis flare or rebound within 4 weeks prior to screening.
Active tuberculosis (TB) or a history of incompletely treated TB per local guidelines.
History of recurrent significant infections.
Active infection or infection treated with antibiotic treatment within 14 days of Study Day 1.
Any history of or active malignancy or myeloproliferative or lymphoproliferative disease.
Current use of the following therapies that may have a possible effect on psoriasis:
Conventional systemic therapy for psoriasis within 28 days prior to Study Day 1 (including but not limited to cyclosporine, corticosteroids, methotrexate, oral retinoids, mycophenolate, thioguanine, hydroxyurea, sirolimus, sulfasalazine, azathioprine, and fumaric acid esters).
Phototherapy treatment (ie, ultraviolet B [UVB], PUVA) within 28 days prior to Study Day 1.
Biologic therapy:
Etanercept (or biosimilar) treatment 28 days prior to Study Day 1
Adalimumab (or biosimilar) treatment 10 weeks prior to Study Day 1
Other TNF or IL-17 blockers (such as infliximab, certolizumab pegol, secukinumab, ixekizumab, brodalumab, or their biosimilars) within 12 weeks prior to Study Day 1
Anti-IL-12 or anti-IL-23 treatment (such as ustekinumab, guselkumab, or tildrakizumab) within 24 weeks prior to Study Day 1.
Use of tanning booths or other ultraviolet light sources.
Answer "Yes" to any question on the Columbia-Suicide Severity Rating Scale during screening or at Study Day 1.
Female participant of childbearing potential with a positive pregnancy test assessed at screening and/or Study Day 1 by a serum and/or urine pregnancy test.
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There are 11 Locations for this study
Scottsdale Arizona, 85255, United States
Scottsdale Arizona, 85255, United States
Santa Monica California, 90404, United States
Thousand Oaks California, 91320, United States
Miami Florida, 33173, United States
Indianapolis Indiana, 46250, United States
Missoula Montana, 59804, United States
Tulsa Oklahoma, 74132, United States
Cypress Texas, 77433, United States
Pflugerville Texas, 78660, United States
Sugar Land Texas, 77479, United States
Mill Creek Washington, 98012, United States
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