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

Phase 3

Recruiting

• Conditions: Plaque Psoriasis
• Interventions: Drug: Apremilast

• 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

Study Timeline

• Study First Submitted: 2023-10-12
• Study First Submitted QC: 2023-10-12
• Study First Posted: 2023-10-18
• Study Start: 2023-10-24
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-13
• Last Update Posted: 2025-08-14
• Primary Completion: 2026-07-06
• Study Completion: 2026-07-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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.

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
Tanner Staging of Sexual Maturity	Day 1 and Day 225
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
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 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 Rebound	Up to approximately 285 days

Trial Locations

Locations (30)

Pediatric Skin Research LLC; 🇺🇸 Coral Gables, Florida, 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

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