Clinical Science Institute | Santa Monica, CA
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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.
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Inclusion criteria
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:
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.
Primary purpose
Allocation
Interventional model
Masking
50 participants in 1 patient group
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Central trial contact
Amgen Call Center
Data sourced from clinicaltrials.gov
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