Home › Trials › NCT06088199

Evaluating Apremilast for Children with Mild to Moderate Plaque Psoriasis

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

PHASE3 · Amgen · NCT06088199

This study is testing if a medication called apremilast is safe and well-tolerated for children aged 6 to 17 with mild to moderate plaque psoriasis.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment50 (estimated)
Ages6 Years to 17 Years
SexAll
SponsorAmgen (industry)
Drugs / interventionsAdalimumab, infliximab, certolizumab, secukinumab, ixekizumab, brodalumab, ustekinumab, guselkumab, tildrakizumab, methotrexate
Locations30 sites (Birmingham, Alabama and 29 other locations)
Trial IDNCT06088199 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the safety and tolerability of apremilast in pediatric participants aged 6 to 17 years who have been diagnosed with mild to moderate plaque psoriasis. The study will involve administering the medication to participants who meet specific criteria related to their psoriasis severity and overall health. The primary focus is to determine how well the medication is tolerated in this younger population, which has been less studied in previous research. Participants must have had chronic plaque psoriasis for at least six months and have not responded adequately to topical treatments.

Who should consider this trial

Good fit: Ideal candidates for this study are pediatric patients aged 6 to 17 years with mild to moderate plaque psoriasis who have not adequately responded to topical therapies.

Not a fit: Patients with other forms of psoriasis, such as guttate or pustular psoriasis, or those with active infections may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for children suffering from mild to moderate plaque psoriasis.

How similar studies have performed: Previous studies have shown promising results with apremilast in adult populations, but this specific pediatric application is relatively novel.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Birmingham, Alabama and 29 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Plaque Psoriasis, Apremilast, Otezla, AMG 407, CC-10004, Pediatric, Plaque psoriasis

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.