A Study of Apremilast in Pediatric Participants in Children With Mild to Moderate Plaque Psoriasis
NCT ID: NCT06088199
Last Updated: 2025-11-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
51 participants
INTERVENTIONAL
2023-10-24
2026-08-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
Apremilast
Oral tablet
Interventions
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Apremilast
Oral tablet
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
6 Years
17 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Affiliated Dermatology
Scottsdale, Arizona, United States
Clear Dermatology
Scottsdale, Arizona, United States
Johnson Dermatology Clinic
Fort Smith, Arkansas, United States
Avance Clinical Trials
Laguna Niguel, California, United States
University of California Irvine
Orange, California, United States
MedDerm Associates
San Diego, California, United States
Clinical Science Institute
Santa Monica, California, United States
California Dermatology Institute
Thousand Oaks, California, United States
Pediatric Skin Research LLC
Coral Gables, Florida, United States
Ciocca Dermatology
Miami, Florida, United States
University of South Florida
Tampa, Florida, United States
Endeavor Health Clinical Trials Center
Skokie, Illinois, United States
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, United States
Southern Indiana Clinical Trials
New Albany, Indiana, United States
Great Lakes Research Group Inc- Sheffield
Bay City, Michigan, United States
Henry Ford Medical Center - New Center One
Detroit, Michigan, United States
Dermatology and Skin Cancer Center of Lees Summit
Lee's Summit, Missouri, United States
Boeson Research
Missoula, Montana, United States
Empire Dermatology
East Syracuse, New York, United States
State University of New York, Downstate Medical Center
Manhasset, New York, United States
OptiSkin Medical
New York, New York, United States
Hightower Clinical LLC
Oklahoma City, Oklahoma, United States
Dermatology Research Center of Oklahoma, PLLC
Tulsa, Oklahoma, United States
Oregon Health and Science University
Portland, Oregon, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Studies in Dermatology LLC
Cypress, Texas, United States
Austin Institute for Clinical Research
Pflugerville, Texas, United States
Stride Clinical Research LLC
Sugar Land, Texas, United States
Frontier Derm Partners
Mill Creek, Washington, United States
Countries
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Related Links
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AmgenTrials clinical trials website
Other Identifiers
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20200196
Identifier Type: -
Identifier Source: org_study_id
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