A Study of Apremilast in Pediatric Participants in Children With Mild to Moderate Plaque Psoriasis

Running, not enrolling · Phase 3

Conditions studied: Plaque Psoriasis

In brief

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.

Key facts

Study ID

NCT06088199

Run by

Amgen

People needed

51

Starts

2023-10-24

Expected to finish

2026-08-06

Last updated by the study team

2025-11-17

Who can join

Age: 6 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 may not qualify 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.

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Affiliated Dermatology — Scottsdale, Arizona, United States
• Clear Dermatology — Scottsdale, Arizona, United States
• Johnson Dermatology Clinic — Fort Smith, Arkansas, United States
• Avance Clinical Trials — Laguna Niguel, California, United States
• University of California Irvine — Orange, California, United States
• MedDerm Associates — San Diego, California, United States
• Clinical Science Institute — Santa Monica, California, United States
• California Dermatology Institute — Thousand Oaks, California, United States
• Pediatric Skin Research LLC — Coral Gables, Florida, United States
• Ciocca Dermatology — Miami, Florida, United States
• University of South Florida — Tampa, Florida, United States
• Endeavor Health Clinical Trials Center — Skokie, Illinois, United States
• Dawes Fretzin Clinical Research Group, LLC — Indianapolis, Indiana, United States
• Southern Indiana Clinical Trials — New Albany, Indiana, United States
• Great Lakes Research Group Inc- Sheffield — Bay City, Michigan, United States
• Henry Ford Medical Center - New Center One — Detroit, Michigan, United States
• Dermatology and Skin Cancer Center of Lees Summit — Lee's Summit, Missouri, United States
• Boeson Research — Missoula, Montana, United States
• Empire Dermatology — East Syracuse, New York, United States
• State University of New York, Downstate Medical Center — Manhasset, New York, United States
• OptiSkin Medical — New York, New York, United States
• Hightower Clinical LLC — Oklahoma City, Oklahoma, United States
• Dermatology Research Center of Oklahoma, PLLC — Tulsa, Oklahoma, United States
• Oregon Health and Science University — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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