for people ages 6-17 (full criteria)
at Orange, California and other locations
study started
completion around



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


Plaque Psoriasis, Apremilast, Otezla, AMG 407, CC-10004, Pediatric, Psoriasis


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.


  • University of California Irvine accepting new patients
    Orange California 92868 United States
  • Avance Clinical Trials accepting new patients
    Laguna Niguel California 92677 United States


accepting new patients
Start Date
Completion Date
AmgenTrials clinical trials website
Phase 3 Psoriasis Research Study
Study Type
Expecting 50 study participants
Last Updated