Status:
ACTIVE_NOT_RECRUITING
A Study of Apremilast in Pediatric Participants in Children With Mild to Moderate Plaque Psoriasis
Lead Sponsor:
Amgen
Conditions:
Plaque Psoriasis
Eligibility:
All Genders
6-17 years
Phase:
PHASE3
Brief 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
- 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
- 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.
Key Trial Info
Start Date :
October 24 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 6 2026
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT06088199
Start Date
October 24 2023
End Date
August 6 2026
Last Update
November 17 2025
Active Locations (30)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
2
Affiliated Dermatology
Scottsdale, Arizona, United States, 85255
3
Clear Dermatology
Scottsdale, Arizona, United States, 85255
4
Johnson Dermatology Clinic
Fort Smith, Arkansas, United States, 72916