ACTIVE_NOT_RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

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

Quick Facts

Study Start:2023-10-24
Study Completion:2026-08-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06088199

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.

Ages Eligible for Study:6 Years to 17 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Participants must have a weight of ≥ 20 kg.
  2. * 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.
  3. * Participant is able to swallow the study medication tablet.
  4. * Diagnosis of chronic plaque psoriasis for at least 6 months prior to screening.
  5. * Has mild to moderate plaque psoriasis at screening and Study Visit 1 as defined by:
  6. * Psoriasis Area Severity Index score 2-15,
  7. * Body surface area 2-15%, and
  8. * Static Physician Global Assessment score of 2-3 (mild to moderate)
  9. * Disease inadequately controlled by or inappropriate for topical therapy for psoriasis.
  1. * Guttate, erythrodermic, or pustular psoriasis at screening and Study Day 1.
  2. * Psoriasis flare or rebound within 4 weeks prior to screening.
  3. * Active tuberculosis (TB) or a history of incompletely treated TB per local guidelines.
  4. * History of recurrent significant infections.
  5. * Active infection or infection treated with antibiotic treatment within 14 days of Study Day 1.
  6. * Any history of or active malignancy or myeloproliferative or lymphoproliferative disease.
  7. * Current use of the following therapies that may have a possible effect on psoriasis:
  8. * 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).
  9. * Phototherapy treatment (ie, ultraviolet B \[UVB\], PUVA) within 28 days prior to Study Day 1.
  10. * Biologic therapy:
  11. * Etanercept (or biosimilar) treatment 28 days prior to Study Day 1
  12. * Adalimumab (or biosimilar) treatment 10 weeks prior to Study Day 1
  13. * 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
  14. * Anti-IL-12 or anti-IL-23 treatment (such as ustekinumab, guselkumab, or tildrakizumab) within 24 weeks prior to Study Day 1.
  15. * Use of tanning booths or other ultraviolet light sources.
  16. * Answer "Yes" to any question on the Columbia-Suicide Severity Rating Scale during screening or at Study Day 1.
  17. * 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.

Contacts and Locations

Principal Investigator

MD
STUDY_DIRECTOR
Amgen

Study Locations (Sites)

University of Alabama at Birmingham
Birmingham, Alabama, 35233
United States
Affiliated Dermatology
Scottsdale, Arizona, 85255
United States
Clear Dermatology
Scottsdale, Arizona, 85255
United States
Johnson Dermatology Clinic
Fort Smith, Arkansas, 72916
United States
Avance Clinical Trials
Laguna Niguel, California, 92677
United States
University of California Irvine
Orange, California, 92868
United States
MedDerm Associates
San Diego, California, 92103
United States
Clinical Science Institute
Santa Monica, California, 90404
United States
California Dermatology Institute
Thousand Oaks, California, 91320
United States
Pediatric Skin Research LLC
Coral Gables, Florida, 33146
United States
Ciocca Dermatology
Miami, Florida, 33173
United States
University of South Florida
Tampa, Florida, 33612
United States
Endeavor Health Clinical Trials Center
Skokie, Illinois, 60077
United States
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, 46250
United States
Southern Indiana Clinical Trials
New Albany, Indiana, 47150
United States
Great Lakes Research Group Inc- Sheffield
Bay City, Michigan, 48706
United States
Henry Ford Medical Center - New Center One
Detroit, Michigan, 48202
United States
Dermatology and Skin Cancer Center of Lees Summit
Lee's Summit, Missouri, 64064
United States
Boeson Research
Missoula, Montana, 59804
United States
Empire Dermatology
East Syracuse, New York, 13057
United States
State University of New York, Downstate Medical Center
Manhasset, New York, 11030
United States
OptiSkin Medical
New York, New York, 10029
United States
Hightower Clinical LLC
Oklahoma City, Oklahoma, 73120
United States
Dermatology Research Center of Oklahoma, PLLC
Tulsa, Oklahoma, 74132
United States
Oregon Health and Science University
Portland, Oregon, 97239
United States
Medical University of South Carolina
Charleston, South Carolina, 29425
United States
Studies in Dermatology LLC
Cypress, Texas, 77429
United States
Austin Institute for Clinical Research
Pflugerville, Texas, 78660
United States
Stride Clinical Research LLC
Sugar Land, Texas, 77479
United States
Frontier Derm Partners
Mill Creek, Washington, 98012
United States

Collaborators and Investigators

Sponsor: Amgen

  • MD, STUDY_DIRECTOR, Amgen

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-24
Study Completion Date2026-08-06

Study Record Updates

Study Start Date2023-10-24
Study Completion Date2026-08-06

Terms related to this study

Keywords Provided by Researchers

  • Apremilast
  • Otezla
  • AMG 407
  • CC-10004
  • Pediatric
  • Plaque psoriasis

Additional Relevant MeSH Terms

  • Plaque Psoriasis