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

Description

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.

Conditions

Plaque Psoriasis

Study Overview

Study Details

Study overview

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.

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

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

Condition
Plaque Psoriasis
Intervention / Treatment

-

Contacts and Locations

Birmingham

University of Alabama at Birmingham, Birmingham, Alabama, United States, 35233

Scottsdale

Affiliated Dermatology, Scottsdale, Arizona, United States, 85255

Scottsdale

Clear Dermatology, Scottsdale, Arizona, United States, 85255

Fort Smith

Johnson Dermatology Clinic, Fort Smith, Arkansas, United States, 72916

Laguna Niguel

Avance Clinical Trials, Laguna Niguel, California, United States, 92677

Orange

University of California Irvine, Orange, California, United States, 92868

San Diego

MedDerm Associates, San Diego, California, United States, 92103

Santa Monica

Clinical Science Institute, Santa Monica, California, United States, 90404

Thousand Oaks

California Dermatology Institute, Thousand Oaks, California, United States, 91320

Coral Gables

Pediatric Skin Research, Coral Gables, Florida, United States, 33146

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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.
  • * 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.

Ages Eligible for Study

6 Years to 17 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Amgen,

MD, STUDY_DIRECTOR, Amgen

Study Record Dates

2026-12-17