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

Plaque Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06088199
• Other study ID #: 20200196
• Status: Recruiting
• Phase: Phase 3
• Start date: October 24, 2023
• Est. completion date: December 17, 2026

Study information

• Verified date: May 2024
• Source: Amgen
• Contact: Amgen Call Center
• Phone: 866-572-6436
• Email: medinfo[@]amgen.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 17, 2026
• Est. primary completion date: December 17, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Plaque Psoriasis
• Psoriasis

Intervention

Drug:
• Apremilast
Oral tablet

Locations

Country	Name	City	State
United States	Great Lakes Research Group Inc- Sheffield	Bay City	Michigan
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Pediatric Skin Research	Coral Gables	Florida
United States	Studies in Dermatology LLC	Cypress	Texas
United States	Henry Ford Health System	Detroit	Michigan
United States	Empire Dermatology	East Syracuse	New York
United States	Johnson Dermatology Clinic	Fort Smith	Arkansas
United States	Dawes Fretzin Clinical Research Group, LLC	Indianapolis	Indiana
United States	Avance Clinical Trials	Laguna Niguel	California
United States	Dermatology and Skin Cancer Center of Lees Summit	Lee's Summit	Missouri
United States	Ciocca Dermatology	Miami	Florida
United States	Frontier Derm Partners	Mill Creek	Washington
United States	Boeson Research	Missoula	Montana
United States	OptiSkin Medical	New York	New York
United States	University of California Irvine	Orange	California
United States	Austin Institute for Clinical Research	Pflugerville	Texas
United States	Oregon Health and Science University	Portland	Oregon
United States	MedDerm Associates	San Diego	California
United States	Clinical Science Institute	Santa Monica	California
United States	Affiliated Dermatology	Scottsdale	Arizona
United States	Clear Dermatology	Scottsdale	Arizona
United States	NorthShore University HealthSystem	Skokie	Illinois
United States	Acclaim Dermatology	Sugar Land	Texas
United States	University of South Florida	Tampa	Florida
United States	California Dermatology Institute	Thousand Oaks	California
United States	Dermatology Research Center of Oklahoma, PLLC	Tulsa	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Treatment-emergent Adverse Events		Day 1 up to approximately 285 days
Secondary	Growth and Development as Assessed by Height		Day 1 up to approximately 285 days
Secondary	Growth and Development as Assessed by Weight		Day 1 up to approximately 285 days
Secondary	Growth and Development as Assessed by Body Mass Index (BMI)		Day 1 up to approximately 285 days
Secondary	Columbia-Suicide Severity rating Scale (C-SSRS)		Day 1 to Day 225
Secondary	Tanner Staging of Sexual Maturity		Day 1 and Day 225
Secondary	Number of Participants With Psoriasis Flare		Up to approximately 285 days
Secondary	Number of Participants With Psoriasis Rebound		Up to approximately 285 days
Secondary	Number of Participants Experiencing Diarrhea Sympotms as Assessed by Stool Diaries		Day 1 to Day 225
Secondary	Number of Participants with Clinically Significant Changes in Laboratory Parameters		Up to approximately 225 days
Secondary	Number of Participants with Clinically Significant Changes in Vital Signs		Up to approximately 285 days

External Links

•   AmgenTrials clinical trials website