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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 6 Years - 17 Years
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06088199
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Amgen
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

MD
Principal Investigator Affiliation Amgen
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Plaque Psoriasis
Study Website: View Trial Website
Arms & Interventions

Arms

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.

Interventions

Drug: - Apremilast

Oral tablet

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Affiliated Dermatology, Scottsdale, Arizona

Status

Recruiting

Address

Affiliated Dermatology

Scottsdale, Arizona, 85255

Clear Dermatology, Scottsdale, Arizona

Status

Recruiting

Address

Clear Dermatology

Scottsdale, Arizona, 85255

Johnson Dermatology Clinic, Fort Smith, Arkansas

Status

Recruiting

Address

Johnson Dermatology Clinic

Fort Smith, Arkansas, 72916

Avance Clinical Trials, Laguna Niguel, California

Status

Recruiting

Address

Avance Clinical Trials

Laguna Niguel, California, 92677

University of California Irvine, Orange, California

Status

Recruiting

Address

University of California Irvine

Orange, California, 92868

MedDerm Associates, San Diego, California

Status

Recruiting

Address

MedDerm Associates

San Diego, California, 92103

Clinical Science Institute, Santa Monica, California

Status

Recruiting

Address

Clinical Science Institute

Santa Monica, California, 90404

California Dermatology Institute, Thousand Oaks, California

Status

Recruiting

Address

California Dermatology Institute

Thousand Oaks, California, 91320

Pediatric Skin Research, Coral Gables, Florida

Status

Recruiting

Address

Pediatric Skin Research

Coral Gables, Florida, 33146

Ciocca Dermatology, Miami, Florida

Status

Recruiting

Address

Ciocca Dermatology

Miami, Florida, 33173

University of South Florida, Tampa, Florida

Status

Recruiting

Address

University of South Florida

Tampa, Florida, 33612

NorthShore University HealthSystem, Skokie, Illinois

Status

Recruiting

Address

NorthShore University HealthSystem

Skokie, Illinois, 60077

Indianapolis, Indiana

Status

Recruiting

Address

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, 46250

Bay City, Michigan

Status

Recruiting

Address

Great Lakes Research Group Inc- Sheffield

Bay City, Michigan, 48706

Lee's Summit, Missouri

Status

Recruiting

Address

Dermatology and Skin Cancer Center of Lees Summit

Lee's Summit, Missouri, 64064

Boeson Research, Missoula, Montana

Status

Recruiting

Address

Boeson Research

Missoula, Montana, 59804

Empire Dermatology, East Syracuse, New York

Status

Recruiting

Address

Empire Dermatology

East Syracuse, New York, 13057

OptiSkin Medical, New York, New York

Status

Recruiting

Address

OptiSkin Medical

New York, New York, 10029

Tulsa, Oklahoma

Status

Recruiting

Address

Dermatology Research Center of Oklahoma, PLLC

Tulsa, Oklahoma, 74132

Oregon Health and Science University, Portland, Oregon

Status

Recruiting

Address

Oregon Health and Science University

Portland, Oregon, 97239

Medical University of South Carolina, Charleston, South Carolina

Status

Recruiting

Address

Medical University of South Carolina

Charleston, South Carolina, 29425

Studies in Dermatology LLC, Cypress, Texas

Status

Recruiting

Address

Studies in Dermatology LLC

Cypress, Texas, 77429

Austin Institute for Clinical Research, Pflugerville, Texas

Status

Recruiting

Address

Austin Institute for Clinical Research

Pflugerville, Texas, 78660

Acclaim Dermatology, Sugar Land, Texas

Status

Recruiting

Address

Acclaim Dermatology

Sugar Land, Texas, 77479

Frontier Derm Partners, Mill Creek, Washington

Status

Recruiting

Address

Frontier Derm Partners

Mill Creek, Washington, 98012

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