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

NCT06088199 | Active Not Recruiting Phase 3 FDA Drug

• 1 other identifier: 20200196
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 30

Brief 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.

Conditions

Plaque Psoriasis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Treatment-emergent Adverse Events

  Day 1 up to approximately 285 days

Secondary Outcomes (10)

• 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

Study Arms (1)

Apremilast

EXPERIMENTAL

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

Interventions

Apremilast DRUG

Oral tablet

Also known as: AMG 407, Otezla, CC-10004

Apremilast

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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.

Sponsors & Collaborators

• Amgen: lead

Study Sites (30)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

Affiliated Dermatology

Scottsdale, Arizona, 85255, United States

Location

Clear Dermatology

Scottsdale, Arizona, 85255, United States

Location

Johnson Dermatology Clinic

Fort Smith, Arkansas, 72916, United States

Location

Avance Clinical Trials

Laguna Niguel, California, 92677, United States

Location

University of California Irvine

Orange, California, 92868, United States

Location

MedDerm Associates

San Diego, California, 92103, United States

Location

Clinical Science Institute

Santa Monica, California, 90404, United States

Location

California Dermatology Institute

Thousand Oaks, California, 91320, United States

Location

Pediatric Skin Research LLC

Coral Gables, Florida, 33146, United States

Location

Ciocca Dermatology

Miami, Florida, 33173, United States

Location

University of South Florida

Tampa, Florida, 33612, United States

Location

Endeavor Health Clinical Trials Center

Skokie, Illinois, 60077, United States

Location

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, 46250, United States

Location

Southern Indiana Clinical Trials

New Albany, Indiana, 47150, United States

Location

Great Lakes Research Group Inc- Sheffield

Bay City, Michigan, 48706, United States

Location

Henry Ford Medical Center - New Center One

Detroit, Michigan, 48202, United States

Location

Dermatology and Skin Cancer Center of Lees Summit

Lee's Summit, Missouri, 64064, United States

Location

Boeson Research

Missoula, Montana, 59804, United States

Location

Empire Dermatology

East Syracuse, New York, 13057, United States

Location

State University of New York, Downstate Medical Center

Manhasset, New York, 11030, United States

Location

OptiSkin Medical

New York, New York, 10029, United States

Location

Hightower Clinical LLC

Oklahoma City, Oklahoma, 73120, United States

Location

Dermatology Research Center of Oklahoma, PLLC

Tulsa, Oklahoma, 74132, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Studies in Dermatology LLC

Cypress, Texas, 77429, United States

Location

Austin Institute for Clinical Research

Pflugerville, Texas, 78660, United States

Location

Stride Clinical Research LLC

Sugar Land, Texas, 77479, United States

Location

Frontier Derm Partners

Mill Creek, Washington, 98012, United States

Location

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Interventions

apremilast

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2023
• First Posted: October 18, 2023
• Study Start: October 24, 2023
• Primary Completion (Estimated): August 6, 2026
• Study Completion (Estimated): August 6, 2026
• Last Updated: November 17, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• 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.
• 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.

Locations

US (30)