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Psoriasis drug apremilast tested in kids for safety

NCT ID NCT06088199

Disease control Sponsor: Amgen Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 28, 2026 · Updated 1 time

Summary

This study is testing the safety of the drug apremilast (Otezla) in 51 children and teens aged 6 to 17 with mild to moderate plaque psoriasis. Participants take the drug as an oral tablet, and researchers monitor for side effects, growth, and development. The goal is to see if this existing psoriasis treatment is safe for younger patients.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
apremilast (Otezla)
What this could lead to
If successful, this could confirm that apremilast is a safe option for managing psoriasis in children and teens.
What could go wrong
This is a small, open-label study without a placebo group, so results may not prove effectiveness. Side effects are possible, and long-term safety in growing children is still being studied.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

51 people

The number who actually took part.

Started

Oct 2023

Finished

Aug 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

6 to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

psoriasis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Plaque psoriasis

Contacts and locations

Locations

  • Affiliated Dermatology

    Scottsdale, Arizona, 85255, United States

  • Austin Institute for Clinical Research

    Pflugerville, Texas, 78660, United States

  • Avance Clinical Trials

    Laguna Niguel, California, 92677, United States

  • Boeson Research

    Missoula, Montana, 59804, United States

  • California Dermatology Institute

    Thousand Oaks, California, 91320, United States

  • Ciocca Dermatology

    Miami, Florida, 33173, United States

  • Clear Dermatology

    Scottsdale, Arizona, 85255, United States

  • Clinical Science Institute

    Santa Monica, California, 90404, United States

  • Dawes Fretzin Clinical Research Group, LLC

    Indianapolis, Indiana, 46250, United States

  • Dermatology Research Center of Oklahoma, PLLC

    Tulsa, Oklahoma, 74132, United States

  • Dermatology and Skin Cancer Center of Lees Summit

    Lee's Summit, Missouri, 64064, United States

  • Empire Dermatology

    East Syracuse, New York, 13057, United States

  • Endeavor Health Clinical Trials Center

    Skokie, Illinois, 60077, United States

  • Frontier Derm Partners

    Mill Creek, Washington, 98012, United States

  • Great Lakes Research Group Inc- Sheffield

    Bay City, Michigan, 48706, United States

  • Henry Ford Medical Center - New Center One

    Detroit, Michigan, 48202, United States

  • Hightower Clinical LLC

    Oklahoma City, Oklahoma, 73120, United States

  • Johnson Dermatology Clinic

    Fort Smith, Arkansas, 72916, United States

  • MedDerm Associates

    San Diego, California, 92103, United States

  • Medical University of South Carolina

    Charleston, South Carolina, 29425, United States

  • OptiSkin Medical

    New York, New York, 10029, United States

  • Oregon Health and Science University

    Portland, Oregon, 97239, United States

  • Pediatric Skin Research LLC

    Coral Gables, Florida, 33146, United States

  • Southern Indiana Clinical Trials

    New Albany, Indiana, 47150, United States

  • State University of New York, Downstate Medical Center

    Manhasset, New York, 11030, United States

  • Stride Clinical Research LLC

    Sugar Land, Texas, 77479, United States

  • Studies in Dermatology LLC

    Cypress, Texas, 77429, United States

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233, United States

  • University of California Irvine

    Orange, California, 92868, United States

  • University of South Florida

    Tampa, Florida, 33612, United States

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