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
Status: Recruiting
Location: See all (30) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 6
Maximum Age: 17
Healthy Volunteers: f
View:
• 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.
Locations
United States
Alabama
University of Alabama at Birmingham
RECRUITING
Birmingham
Arkansas
Johnson Dermatology Clinic
RECRUITING
Fort Smith
Arizona
Affiliated Dermatology
TERMINATED
Scottsdale
Clear Dermatology
RECRUITING
Scottsdale
California
Avance Clinical Trials
RECRUITING
Laguna Niguel
University of California Irvine
RECRUITING
Orange
MedDerm Associates
RECRUITING
San Diego
Clinical Science Institute
TERMINATED
Santa Monica
California Dermatology Institute
RECRUITING
Thousand Oaks
Florida
Pediatric Skin Research LLC
RECRUITING
Coral Gables
Ciocca Dermatology
RECRUITING
Miami
University of South Florida
RECRUITING
Tampa
Illinois
Endeavor Health Clinical Trials Center
RECRUITING
Skokie
Indiana
Dawes Fretzin Clinical Research Group, LLC
RECRUITING
Indianapolis
Southern Indiana Clinical Trials
RECRUITING
New Albany
Michigan
Great Lakes Research Group Inc- Sheffield
RECRUITING
Bay City
Henry Ford Cancer Detroit (Brigitte Harris Cancer Pavilion)
RECRUITING
Detroit
Missouri
Dermatology and Skin Cancer Center of Lees Summit
RECRUITING
Lee's Summit
Montana
Boeson Research
RECRUITING
Missoula
New York
Empire Dermatology
RECRUITING
East Syracuse
State University of New York, Downstate Medical Center
RECRUITING
Manhasset
OptiSkin Medical
RECRUITING
New York
Oklahoma
Hightower Clinical LLC
TERMINATED
Oklahoma City
Dermatology Research Center of Oklahoma, PLLC
TERMINATED
Tulsa
Oregon
Oregon Health and Science University
RECRUITING
Portland
South Carolina
Medical University of South Carolina
RECRUITING
Charleston
Texas
Studies in Dermatology LLC
RECRUITING
Cypress
Austin Institute for Clinical Research
TERMINATED
Pflugerville
Stride Clinical Research LLC
RECRUITING
Sugar Land
Washington
Frontier Derm Partners
RECRUITING
Mill Creek
Contact Information
Primary
Amgen Call Center
medinfo@amgen.com
866-572-6436
Time Frame
Start Date:2023-10-24
Estimated Completion Date:2026-07-06
Participants
Target number of participants:50
Treatments
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.