A Study of Apremilast in Pediatric Participants in Children With Mild to Moderate Plaque Psoriasis
- Registration Number
- NCT06088199
- Lead Sponsor
- Amgen
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 50
- 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.
-
Guttate, erythrodermic, or pustular psoriasis at screening and Study Day 1.
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Psoriasis flare or rebound within 4 weeks prior to screening.
-
Active tuberculosis (TB) or a history of incompletely treated TB per local guidelines.
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History of recurrent significant infections.
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Active infection or infection treated with antibiotic treatment within 14 days of Study Day 1.
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Any history of or active malignancy or myeloproliferative or lymphoproliferative disease.
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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).
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Phototherapy treatment (ie, ultraviolet B [UVB], PUVA) within 28 days prior to Study Day 1.
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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.
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Use of tanning booths or other ultraviolet light sources.
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Answer "Yes" to any question on the Columbia-Suicide Severity Rating Scale during screening or at Study Day 1.
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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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Apremilast 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.
- Primary Outcome Measures
Name Time Method Number of Participants With Treatment-emergent Adverse Events Day 1 up to approximately 285 days
- Secondary Outcome Measures
Name Time Method Number of Participants Experiencing Diarrhea Sympotms as Assessed by Stool Diaries Day 1 to Day 225 Number of Participants with Clinically Significant Changes in Laboratory Parameters Up to approximately 225 days Growth and Development as Assessed by Weight Day 1 up to approximately 285 days Number of Participants With Psoriasis Flare Up to approximately 285 days Growth and Development as Assessed by Height Day 1 up to approximately 285 days Tanner Staging of Sexual Maturity Day 1 and Day 225 Number of Participants with Clinically Significant Changes in Vital Signs 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 Number of Participants With Psoriasis Rebound Up to approximately 285 days
Trial Locations
- Locations (30)
Endeavor Health Clinical Trials Center
🇺🇸Skokie, Illinois, United States
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
🇺🇸Coral Gables, Florida, United States
Ciocca Dermatology
🇺🇸Miami, Florida, United States
University of South Florida
🇺🇸Tampa, Florida, 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 Cancer Detroit (Brigitte Harris Cancer Pavilion)
🇺🇸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
Frontier Derm Partners
🇺🇸Mill Creek, Washington, United States
Stride Clinical Research LLC
🇺🇸Sugar Land, Texas, United States