A Study of Apremilast in Pediatric Participants in Children With Mild to Moderate Plaque Psoriasis
UCI Specialty Area: Dermatology
Principal Investigator:
Michelle Min
Official Title:
A Phase 3, Multi-center, Open-Label, Single-arm Study to Assess the Safety of Apremilast (AMG 407) in Pediatric Subjects from 6 Through 17 Years of Age with Mild to Moderate Plaque Psoriasis
A Study On:
Psoriasis
Skin - Dermatologic
Study Description
Eligibility
- Participants must have a weight of greater than or equal to 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.
- 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:
a) Etanercept (or biosimilar) treatment 28 days prior to Study Day 1
b) Adalimumab (or biosimilar) treatment 10 weeks prior to Study Day 1
c) 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
d) 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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