A Study of Apremilast in Pediatric Participants in Children With Mild to Moderate Plaque Psoriasis
a study on Psoriasis
Summary
- Eligibility
- for people ages 6-17 (full criteria)
- Location
- at UC Irvine
- Dates
- study startedcompletion around
Description
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.
Official Title
A Phase 3, Multi-center, Open-label, Single-arm Study to Assess the Safety of Apremilast (AMG 407) in Pediatric Participants From 6 Through 17 Years of Age With Mild to Moderate Plaque Psoriasis
Keywords
Plaque Psoriasis, Apremilast, Otezla, AMG 407, CC-10004, Pediatric, Psoriasis
Eligibility
You can join if…
Open to people ages 6-17
- 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.
You CAN'T join if...
- 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.
Locations
- University of California Irvine
accepting new patients
Orange California 92868 United States - Clinical Science Institute
terminated
Santa Monica California 90404 United States - MedDerm Associates
accepting new patients
San Diego California 92103 United States - Avance Clinical Trials
accepting new patients
Laguna Niguel California 92677 United States - California Dermatology Institute
accepting new patients
Thousand Oaks California 91320 United States
Details
- Status
- accepting new patients
- Start Date
- Completion Date
- (estimated)
- Sponsor
- Amgen
- Links
- AmgenTrials clinical trials website
- ID
- NCT06088199
- Phase
- Phase 3 Psoriasis Research Study
- Study Type
- Interventional
- Participants
- Expecting 50 study participants
- Last Updated