Psoriasis Clinical Trial

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

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.

View Eligibility Criteria

Eligibility Criteria

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 is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

50

Study ID:

NCT06088199

Recruitment Status:

Recruiting

Sponsor:

Amgen

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 25 Locations for this study

See Locations Near You

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
Coral Gables Florida, 33146, United States
Ciocca Dermatology
Miami Florida, 33173, United States
University of South Florida
Tampa Florida, 33612, United States
NorthShore University HealthSystem
Skokie Illinois, 60077, United States
Dawes Fretzin Clinical Research Group, LLC
Indianapolis Indiana, 46250, United States
Great Lakes Research Group Inc- Sheffield
Bay City Michigan, 48706, United States
Henry Ford Health System
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
OptiSkin Medical
New York New York, 10029, 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
Acclaim Dermatology
Sugar Land Texas, 77479, United States
Frontier Derm Partners
Mill Creek Washington, 98012, United States

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

50

Study ID:

NCT06088199

Recruitment Status:

Recruiting

Sponsor:


Amgen

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.