A Study of Apremilast in Pediatric Participants in Children 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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Plaque Psoriasis
• Intervention / Treatment: Drug: Apremilast

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 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.

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 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Apremilast; Apremilast will be dosed by participant's body weight and administered twice daily (BID) in the form of oral tablets, approximately 12 hours apart, without restriction of food or drink.	Drug: Apremilast; Oral tablet; Other Names: CC-10004; Otezla; AMG 407

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Participants With Treatment-emergent Adverse Events	Day 1 up to approximately 285 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Growth and Development as Assessed by Height	Day 1 up to approximately 285 days
Growth and Development as Assessed by Weight	Day 1 up to approximately 285 days
Growth and Development as Assessed by Body Mass Index (BMI)	Day 1 up to approximately 285 days
Columbia-Suicide Severity rating Scale (C-SSRS)	Day 1 to Day 225
Tanner Staging of Sexual Maturity	Day 1 and Day 225
Number of Participants With Psoriasis Flare	Up to approximately 285 days
Number of Participants With Psoriasis Rebound	Up to approximately 285 days
Number of Participants Experiencing Diarrhea Sympotms as Assessed by Stool Diaries	Day 1 to Day 225
Number of Participants with Clinically Significant Changes in Laboratory Parameters	Up to approximately 225 days
Number of Participants with Clinically Significant Changes in Vital Signs	Up to approximately 285 days

Collaborators and Investigators

• Sponsor: Amgen
• Investigators: Study Director: MD, Amgen

Publications and helpful links

Helpful Links

• AmgenTrials clinical trials website

Study record dates

Study Major Dates

• Study Start (Actual): October 24, 2023
• Primary Completion (Estimated): August 6, 2026
• Study Completion (Estimated): August 6, 2026

Study Registration Dates

• First Submitted: October 12, 2023
• First Submitted That Met QC Criteria: October 12, 2023
• First Posted (Actual): October 18, 2023

Study Record Updates

• Last Update Posted (Actual): November 17, 2025
• Last Update Submitted That Met QC Criteria: November 14, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Pediatric; CC-10004; Apremilast; Otezla; Plaque psoriasis; AMG 407
• Additional Relevant MeSH Terms: Skin Diseases, Papulosquamous; Skin Diseases; Psoriasis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Antirheumatic Agents; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Anti-Inflammatory Agents, Non-Steroidal; Phosphodiesterase Inhibitors; Phosphodiesterase 4 Inhibitors; apremilast
• Other Study ID Numbers: 20200196

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
• IPD Sharing Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
• IPD Sharing Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No