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Completed
NCT06088199
A Study of Apremilast in Pediatric Participants in Children With Mild to Moderate Plaque Psoriasis
Conditions: Plaque Psoriasis
Sex: All
Ages: 6 Years – 17 Years
Healthy volunteers: No
Phase: PHASE3
Enrollment: 51
Sponsor: Amgen
Location: University of Alabama at Birmingham Birmingham Alabama
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.
Source: ClinicalTrials.gov (NCT06088199). StuddyBuddy aggregates publicly available trial information.