Clinical trial NCT06088199: A Study of Apremilast in Pediatric Participants in Children With Mild to Moderate Plaque Psoriasis
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Plaque Psoriasis
Keywords: Apremilast
Otezla
AMG 407
CC-10004
Pediatric
Plaque psoriasis
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2023-10-18
Enrollment: 50
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Number of Participants With Treatment-emergent Adverse Events
timeFrame: Day 1 up to approximately 285 days
Secondary outcomes:
measure: Growth and Development as Assessed by Height
timeFrame: Day 1 up to approximately 285 days
measure: Growth and Development as Assessed by Weight
timeFrame: Day 1 up to approximately 285 days
measure: Growth and Development as Assessed by Body Mass Index (BMI)
timeFrame: Day 1 up to approximately 285 days
measure: Columbia-Suicide Severity rating Scale (C-SSRS)
timeFrame: Day 1 to Day 225
measure: Tanner Staging of Sexual Maturity
timeFrame: Day 1 and Day 225
measure: Number of Participants With Psoriasis Flare
timeFrame: Up to approximately 285 days
measure: Number of Participants With Psoriasis Rebound
timeFrame: Up to approximately 285 days
measure: Number of Participants Experiencing Diarrhea Sympotms as Assessed by Stool Diaries
timeFrame: Day 1 to Day 225
measure: Number of Participants with Clinically Significant Changes in Laboratory Parameters
timeFrame: Up to approximately 225 days
measure: Number of Participants with Clinically Significant Changes in Vital Signs
timeFrame: Up to approximately 285 days
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Scottsdale
country: United States
facility: Affiliated Dermatology
state: Arizona
city: Scottsdale
country: United States
facility: Clear Dermatology
state: Arizona
city: Fort Smith
country: United States
facility: Johnson Dermatology Clinic
state: Arkansas
city: Laguna Niguel
country: United States
facility: Avance Clinical Trials
state: California
city: Orange
country: United States
facility: University of California Irvine
state: California
city: San Diego
country: United States
facility: MedDerm Associates
state: California
city: Santa Monica
country: United States
facility: Clinical Science Institute
state: California
city: Thousand Oaks
country: United States
facility: California Dermatology Institute
state: California
city: Coral Gables
country: United States
facility: Pediatric Skin Research
state: Florida
city: Miami
country: United States
facility: Ciocca Dermatology
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Skokie
country: United States
facility: Endeavor Health Clinical Trials Center
state: Illinois
city: Indianapolis
country: United States
facility: Dawes Fretzin Clinical Research Group, LLC
state: Indiana
city: New Albany
country: United States
facility: Southern Indiana Clinical Trials
state: Indiana
city: Bay City
country: United States
facility: Great Lakes Research Group Inc- Sheffield
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Cancer Detroit (Brigitte Harris Cancer Pavilion)
state: Michigan
city: Lee's Summit
country: United States
facility: Dermatology and Skin Cancer Center of Lees Summit
state: Missouri
city: Missoula
country: United States
facility: Boeson Research
state: Montana
city: East Syracuse
country: United States
facility: Empire Dermatology
state: New York
city: Manhasset
country: United States
facility: State University of New York, Downstate Medical Center
state: New York
city: New York
country: United States
facility: OptiSkin Medical
state: New York
city: Oklahoma City
country: United States
facility: Hightower Clinical LLC
state: Oklahoma
city: Tulsa
country: United States
facility: Dermatology Research Center of Oklahoma, PLLC
state: Oklahoma
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Cypress
country: United States
facility: Studies in Dermatology LLC
state: Texas
city: Pflugerville
country: United States
facility: Austin Institute for Clinical Research
state: Texas
city: Sugar Land
country: United States
facility: Stride Clinical Research LLC
state: Texas
city: Mill Creek
country: United States
facility: Frontier Derm Partners
state: Washington
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: