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

Last updated: April 2, 2025
Sponsor: Amgen
Overall Status: Active - Recruiting

Phase

3

Condition

Rash

Rosacea

Warts

Treatment

Apremilast

Clinical Study ID

NCT06088199
20200196
  • Ages 6-17
  • All Genders

Study 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

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 thefifth 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 forpsoriasis.

Exclusion

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 localguidelines.

  • History of recurrent significant infections.

  • Active infection or infection treated with antibiotic treatment within 14 days ofStudy Day 1.

  • Any history of or active malignancy or myeloproliferative or lymphoproliferativedisease.

  • 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, oralretinoids, mycophenolate, thioguanine, hydroxyurea, sirolimus, sulfasalazine,azathioprine, and fumaric acid esters).

  • Phototherapy treatment (ie, ultraviolet B [UVB], PUVA) within 28 days prior to StudyDay 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 weeksprior to Study Day 1

  • Anti-IL-12 or anti-IL-23 treatment (such as ustekinumab, guselkumab, ortildrakizumab) 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 duringscreening or at Study Day 1.

  • Female participant of childbearing potential with a positive pregnancy test assessedat screening and/or Study Day 1 by a serum and/or urine pregnancy test.

Study Design

Total Participants: 50
Treatment Group(s): 1
Primary Treatment: Apremilast
Phase: 3
Study Start date:
October 24, 2023
Estimated Completion Date:
July 06, 2026

Connect with a study center

  • University of Alabama at Birmingham

    Birmingham, Alabama 35233
    United States

    Active - Recruiting

  • Affiliated Dermatology

    Scottsdale, Arizona 85255
    United States

    Terminated

  • Clear Dermatology

    Scottsdale, Arizona 85255
    United States

    Active - Recruiting

  • Johnson Dermatology

    Fort Smith, Arkansas 72916
    United States

    Active - Recruiting

  • Johnson Dermatology Clinic

    Fort Smith, Arkansas 72916
    United States

    Active - Recruiting

  • Avance Clinical Trials

    Laguna Niguel, California 92677
    United States

    Active - Recruiting

  • University of California Irvine

    Orange, California 92868
    United States

    Active - Recruiting

  • MedDerm Associates

    San Diego, California 92103
    United States

    Active - Recruiting

  • Clinical Science Institute

    Santa Monica, California 90404
    United States

    Terminated

  • California Dermatology Institute

    Thousand Oaks, California 91320
    United States

    Active - Recruiting

  • Pediatric Skin Research

    Coral Gables, Florida 33146
    United States

    Active - Recruiting

  • Ciocca Dermatology

    Miami, Florida 33173
    United States

    Active - Recruiting

  • University of South Florida

    Tampa, Florida 33612
    United States

    Active - Recruiting

  • Endeavor Health Clinical Trials Center

    Skokie, Illinois 60077
    United States

    Active - Recruiting

  • NorthShore University HealthSystem

    Skokie, Illinois 60077
    United States

    Active - Recruiting

  • Dawes Fretzin Clinical Research Group, LLC

    Indianapolis, Indiana 46250
    United States

    Active - Recruiting

  • Southern Indiana Clinical Trials

    New Albany, Indiana 47150
    United States

    Active - Recruiting

  • Great Lakes Research Group Inc- Sheffield

    Bay City, Michigan 48706
    United States

    Active - Recruiting

  • Henry Ford Cancer Detroit (Brigitte Harris Cancer Pavilion)

    Detroit, Michigan 48202
    United States

    Active - Recruiting

  • Henry Ford Health System

    Detroit, Michigan 48202
    United States

    Active - Recruiting

  • Dermatology and Skin Cancer Center of Lees Summit

    Lee's Summit, Missouri 64064
    United States

    Active - Recruiting

  • Boeson Research

    Missoula, Montana 59804
    United States

    Active - Recruiting

  • Empire Dermatology

    East Syracuse, New York 13057
    United States

    Active - Recruiting

  • State University of New York, Downstate Medical Center

    Manhasset, New York 11030
    United States

    Active - Recruiting

  • OptiSkin Medical

    New York, New York 10029
    United States

    Active - Recruiting

  • Hightower Clinical LLC

    Oklahoma City, Oklahoma 73120
    United States

    Active - Recruiting

  • Dermatology Research Center of Oklahoma, PLLC

    Tulsa, Oklahoma 74132
    United States

    Active - Recruiting

  • Oregon Health and Science University

    Portland, Oregon 97239
    United States

    Active - Recruiting

  • Medical University of South Carolina

    Charleston, South Carolina 29425
    United States

    Active - Recruiting

  • Studies in Dermatology

    Cypress, Texas 77433
    United States

    Active - Recruiting

  • Studies in Dermatology LLC

    Cypress, Texas 77429
    United States

    Active - Recruiting

  • Stride Clinical Research LLC

    Missouri City, Texas 77459
    United States

    Site Not Available

  • Austin Institute for Clinical Research

    Pflugerville, Texas 78660
    United States

    Terminated

  • Acclaim Dermatology

    Sugar Land, Texas 77479
    United States

    Site Not Available

  • Stride Clinical Research LLC

    Sugar Land, Texas 77479
    United States

    Active - Recruiting

  • Frontier Derm Partners

    Mill Creek, Washington 98012
    United States

    Active - Recruiting

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