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Status:

ACTIVE_NOT_RECRUITING

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

Lead Sponsor:

Amgen

Conditions:

Plaque Psoriasis

Eligibility:

All Genders

6-17 years

Phase:

PHASE3

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

  • 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

  • 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.

Key Trial Info

Start Date :

October 24 2023

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

August 6 2026

Estimated Enrollment :

51 Patients enrolled

Trial Details

Trial ID

NCT06088199

Start Date

October 24 2023

End Date

August 6 2026

Last Update

November 17 2025

Active Locations (30)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 8 (30 locations)

1

University of Alabama at Birmingham

Birmingham, Alabama, United States, 35233

2

Affiliated Dermatology

Scottsdale, Arizona, United States, 85255

3

Clear Dermatology

Scottsdale, Arizona, United States, 85255

4

Johnson Dermatology Clinic

Fort Smith, Arkansas, United States, 72916