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Active, Not Recruiting

NCT Number: NCT06088199

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Alabama at Birmingham, Birmingham, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Apremilast

Drug

Oral tablet

Other names: AMG 407, Otezla, CC-10004

Primary outcomes

  1. Number of Participants With Treatment-emergent Adverse Events

    Time frame: Day 1 up to approximately 285 days

Secondary outcomes

  1. Growth and Development as Assessed by Height

    Time frame: Day 1 up to approximately 285 days

  2. Growth and Development as Assessed by Weight

    Time frame: Day 1 up to approximately 285 days

  3. Growth and Development as Assessed by Body Mass Index (BMI)

    Time frame: Day 1 up to approximately 285 days

  4. Columbia-Suicide Severity rating Scale (C-SSRS)

    Time frame: Day 1 to Day 225

  5. Tanner Staging of Sexual Maturity

    Time frame: Day 1 and Day 225

  6. Number of Participants With Psoriasis Flare

    Time frame: Up to approximately 285 days

  7. Number of Participants With Psoriasis Rebound

    Time frame: Up to approximately 285 days

  8. Number of Participants Experiencing Diarrhea Sympotms as Assessed by Stool Diaries

    Time frame: Day 1 to Day 225

  9. Number of Participants with Clinically Significant Changes in Laboratory Parameters

    Time frame: Up to approximately 225 days

  10. Number of Participants with Clinically Significant Changes in Vital Signs

    Time frame: Up to approximately 285 days

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Oct 18, 2023
Registry last updated
Nov 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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