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Kids with psoriasis get extended relief in new drug study

NCT ID NCT04175613

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study looked at the long-term safety and effects of the drug apremilast in 160 children aged 6 to 17 with moderate to severe plaque psoriasis. Participants who had already completed one year of treatment could continue taking the drug for up to 208 weeks (about 4 years). The goal was to monitor side effects, growth, and sexual development while managing the skin condition over time.

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

160 people

The number who actually took part.

Started

Dec 2019

Finished

Dec 2025

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: Subject must satisfy the following criteria to be enrolled in the study: 1. Subject is male or female 6 to 17 years of age, inclusive, at the time the informed consent document is signed by the legal guardian. 2. Subject must have a weight of ≥ 20 kg. 3. Subjects must have an age and sex specific BMI value no lower in range than the 5th percentile on the Centers for Disease Control (CDC) growth chart for children and adolescents. 4. Subject must have completed Week 52 (Apremilast Extension Phase) of Study CC-10004-PPSO-003. 5. Subject is able to sign an assent with a legal guardian/s who understand/s and voluntarily sign/s an informed consent prior to any study-related assessments/procedures being conducted. 6. Subject is willing and able to adhere to the study visit schedule and other protocol requirements. 7. All female subjects of childbearing potential (FCBP) must either practice abstinence from heterosexual contact or use one of the approved contraceptive options as described below while on apremilast and for at least 28 days after administration of the last dose of apremilast. For the purpose of this study, a female subject is considered of childbearing potential if she is ≥ 12 years old or has reached menarche, whichever occurred first. At the time of study entry, and at any time during the study when a female subject of childbearing potential's contraceptive measures or ability to become pregnant changes, the Investigator will educate the subject regarding abstinence or contraception options and the correct and consistent use of effective contraceptive methods in order to successfully prevent pregnancy. Females of childbearing potential must have a negative pregnancy test at each visit. All FCBP who engage in activity in which conception is possible must use one of the approved contraceptive options described below: Option 1: Any one of the following effective methods: hormonal contraception (oral, injection, implant, transdermal patch, vaginal ring); intrauterine device (IUD); tubal ligation; or partner's vasectomy; OR Option 2: Male or female condom or nonlatex condom NOT made out of natural \[animal\] membrane \[for example, polyurethane\]; PLUS one additional barrier method: (a) diaphragm with spermicide; (b) cervical cap with spermicide; or (c) contraceptive sponge with spermicide. NOTE: Option 2 may not be acceptable as a contraception option in all countries per local guidelines/regulations. Exclusion Criteria: The presence of any of the following will exclude a subject from enrollment: 1. Subject has a condition, including the presence of laboratory abnormalities, or psychiatric illness, that would place the subject at unacceptable risk if he/she were to participate in the study. 2. Subject has a condition that confounds the ability to interpret data from the study. 3. Subject has evidence of skin conditions, other than psoriasis, that would interfere with clinical assessments. 4. Subject is pregnant or breastfeeding. 5. Subject has guttate, erythrodermic, or pustular psoriasis. 6. Subject has active tuberculosis (TB) or a history of incompletely treated TB. 7. Subject answers "Yes" to any question on the Columbia-Suicide Severity Rating Scale at Visit 16 of study CC-10004-PPSO-003. 8. Subject plans concurrent use of the following therapies that may have a possible effect on psoriasis. 1. Conventional systemic therapy for psoriasis (including but not limited to cyclosporine, corticosteroids, methotrexate, oral retinoids, mycophenolate, thioguanine, hydroxyurea, sirolimus, sulfasalazine, azathioprine, and fumaric acid esters) 2. Biologic therapy: i. Etanercept (or biosimilar) treatment ii. Adalimumab (or biosimilar) treatment iii. Other TNF or interleukin (IL)-17 blockers (such as infliximab, certolizumab pegol, secukinumab, ixekizumab, brodalumab, or their biosimilars) iv. Anti-IL-12 or anti-IL-23 treatment (such as ustekinumab, guselkumab, or tildrakizumab) c) Use of any investigational drug other than apremilast 9. Subject has prolonged sun exposure or use of tanning booths or other ultraviolet (UV) light sources. 10. Children in Care: a child who has been placed under the control or protection of an agency, organization, institution or entity by the courts, the government or a government body, acting in accordance with powers conferred on them by law or regulation.

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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.

Psoriasis

Contacts and locations

Locations

  • Altai State Medical University

    Barnaul, 656038, Russia

  • AvantDerm

    Toronto, Ontario, M5A 3R6, Canada

  • Azienda Ospedaliera di Padova

    Padova, 35020, Italy

  • Azienda Ospedaliero Universitaria Di Cagliari

    Cagliari, 09124, Italy

  • Bashkiria State Medical University

    Ufa, 450083, Russia

  • Cabinet du Docteur Ruer-Mulard Mireille

    Martigues, 13500, France

  • California Dermatology Institute

    Thousand Oaks, California, 91320, United States

  • Centre Hospitalier Universitaire Saint Pierre

    Brussels, 1000, Belgium

  • Centre Hospitalier Universitaire de Toulouse - Hopital Larrey

    Toulouse, 31400, France

  • Chelyabinsk Regional Clinical Skin and Venereal Dispensary

    Chelyabinsk, 454048, Russia

  • Ciocca Dermatology

    Miami, Florida, 33173, United States

  • Clinical Dispensary of Dermatology and Venereology of Krasnodar Territory of the Ministry of Health

    Krasnodar, 350020, Russia

  • Cliniques Universitaires Saint Luc

    Brussels, 1200, Belgium

  • Dawes Fretzin Dermatology Group Inc

    Indianapolis, Indiana, 46256, United States

  • Driscoll Childrens Hospital

    San Antonio, Texas, 78218, United States

  • Fakultni nemocnice Kralovske Vinohrady

    Prague, 100 34, Czechia

  • First OC Dermatology

    Irvine, California, 92697, United States

  • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

    Milan, 20122, Italy

  • General University Hospital of Alicante

    Alicante, 3010, Spain

  • Hopsital Germans Trias I Pujol

    Badalona, 08916, Spain

  • Hospital 12 de Octubre

    Madrid, 28041, Spain

  • Hospital General Universitario Gregorio Maranon

    Madrid, 28007, Spain

  • Hospital Infantil Universitario Nino Jesus

    Madrid, 28009, Spain

  • Hospital La Paz

    Madrid, 28046, Spain

  • Hospital Marques de Valdecilla

    Santander, 39008, Spain

  • Hospital Sant Joan de Deu

    Esplugues de Llobregat, Catalonia, 08950, Spain

  • Johnson Dermatology Clinic

    Fort Smith, Arkansas, 72916, United States

  • Karma Clinical Trials

    St. John's, Newfoundland and Labrador, A1C 2H5, Canada

  • LLC Medical Center Zdorovaya Semiya

    Novosibirsk, 630099, Russia

  • LLC PiterKlinika

    Saint Petersburg, 196158, Russia

  • Medical University of South Carolina

    Charleston, South Carolina, 29425, United States

  • Moscow Scientific Practical Center of Dermatology Venerology and Cosmetology

    Moscow, 119071, Russia

  • National Medical Research Center for Children Health

    Moscow, 119991, Russia

  • Phoenix Childrens Hospital

    Phoenix, Arizona, 85016, United States

  • Pierre Wolkenshtein Skin Diseases Clinic LLC

    Saint Petersburg, 191123, Russia

  • Republican Clinical Dermatology and Venerology Dispensary

    Kazan', 420012, Russia

  • Saint Petersburg State Pediatric Medical University

    Saint Petersburg, 194100, Russia

  • Skin Care Physicians of Georgia

    Macon, Georgia, 31217, United States

  • Solutions Through Advanced Research Inc

    Jacksonville, Florida, 32256, United States

  • Soroka University Medical Center

    Bear Sheva, 8410101, Israel

  • Stanford University School of Medicine

    Palo Alto, California, 94304, United States

  • State Scientific Center for Dermatovenereology and Cosmetology

    Moscow, 107076, Russia

  • Stollery Childrens Hospital

    Edmonton, Alberta, T6G 2B7, Canada

  • Synexus Czech sro

    Prague, 120 00, Czechia

  • Universitair Ziekenhuis Gent

    Ghent, 9000, Belgium

  • University of Wisconsin Hospital and Clinics

    Madison, Wisconsin, 53715-1375, United States

  • Ural Scientific Research Institute of Dermatovenereology and Immunopathology

    Yekaterinburg, 620076, Russia

  • Winnipeg Clinic Dermatology Research

    Winnipeg, Manitoba, R3C 0N2, Canada

  • Wright State Physicians

    Fairborn, Ohio, 45324, United States

  • Yarosavl State Medical Academy

    Yaroslavl, 150000, Russia

More trials for these conditions

Other studies related to the condition(s) this trial covers.