A Long-term Extension Study of Apremilast (CC-10004) in Pediatric Subjects From 6 Through 17 Years of Age With Moderate to Severe Plaque Psoriasis

Last updated: June 11, 2025
Sponsor: Amgen
Overall Status: Active - Not Recruiting

Phase

3

Condition

Warts

Rosacea

Scalp Disorders

Treatment

Apremilast

Clinical Study ID

NCT04175613
CC-10004-PPSO-004
2019-003497-13
U1111-1242-3537
  • Ages 6-17
  • All Genders

Study Summary

This study was created to provide subjects who complete Week 52 (end of Apremilast Extension Phase) of study CC-10004-PPSO-003 the option to continue to receive open-label apremilast therapy.

The study will consist of up to 208 weeks of long-term treatment followed by an 8-week observational follow-up phase.

Eligibility Criteria

Inclusion

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 informedconsent 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 5thpercentile on the Centers for Disease Control (CDC) growth chart for children andadolescents.

  4. Subject must have completed Week 52 (Apremilast Extension Phase) of StudyCC-10004-PPSO-003.

  5. Subject is able to sign an assent with a legal guardian/s who understand/s andvoluntarily sign/s an informed consent prior to any study-relatedassessments/procedures being conducted.

  6. Subject is willing and able to adhere to the study visit schedule and other protocolrequirements.

  7. All female subjects of childbearing potential (FCBP) must either practice abstinencefrom heterosexual contact or use one of the approved contraceptive options asdescribed below while on apremilast and for at least 28 days after administration ofthe last dose of apremilast. For the purpose of this study, a female subject isconsidered of childbearing potential if she is ≥ 12 years old or has reachedmenarche, 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

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, orpsychiatric illness, that would place the subject at unacceptable risk if he/shewere 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 interferewith 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 Scaleat Visit 16 of study CC-10004-PPSO-003.

  8. Subject plans concurrent use of the following therapies that may have a possibleeffect on psoriasis.

  9. Conventional systemic therapy for psoriasis (including but not limited tocyclosporine, corticosteroids, methotrexate, oral retinoids, mycophenolate,thioguanine, hydroxyurea, sirolimus, sulfasalazine, azathioprine, and fumaricacid esters)

  10. Biologic therapy: i. Etanercept (or biosimilar) treatment ii. Adalimumab (or biosimilar) treatmentiii. Other TNF or interleukin (IL)-17 blockers (such as infliximab, certolizumabpegol, secukinumab, ixekizumab, brodalumab, or their biosimilars) iv. Anti-IL-12 oranti-IL-23 treatment (such as ustekinumab, guselkumab, or tildrakizumab) c) Use ofany investigational drug other than apremilast

  11. Subject has prolonged sun exposure or use of tanning booths or other ultraviolet (UV) light sources.

  12. Children in Care: a child who has been placed under the control or protection of anagency, organization, institution or entity by the courts, the government or agovernment body, acting in accordance with powers conferred on them by law orregulation.

Study Design

Total Participants: 160
Treatment Group(s): 1
Primary Treatment: Apremilast
Phase: 3
Study Start date:
December 20, 2019
Estimated Completion Date:
December 16, 2025

Connect with a study center

  • Centre Hospitalier Universitaire Saint Pierre

    Brussels, 1000
    Belgium

    Site Not Available

  • Cliniques Universitaires Saint Luc

    Brussels, 1200
    Belgium

    Site Not Available

  • Universitair Ziekenhuis Gent

    Gent, 9000
    Belgium

    Site Not Available

  • Stollery Children's Hospital

    Edmonton, Alberta T6G 2B7
    Canada

    Site Not Available

  • Stollery Childrens Hospital

    Edmonton, Alberta T6G 2B7
    Canada

    Site Not Available

  • Winnipeg Clinic Dermatology Research

    Winnipeg, Manitoba R3C 0N2
    Canada

    Site Not Available

  • Karma Clinical Trials

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

    Site Not Available

  • AvantDerm

    Toronto, Ontario M5A 3R6
    Canada

    Site Not Available

  • Synexus Czech sro

    Praha, 120 00
    Czechia

    Site Not Available

  • Fakultni nemocnice Kralovske Vinohrady

    Praha 10, 100 34
    Czechia

    Site Not Available

  • Cabinet du Docteur Ruer-Mulard Mireille

    Martigues, 13500
    France

    Site Not Available

  • Centre Hospitalier Universitaire de Toulouse - Hopital Larrey

    Toulouse, 31400
    France

    Site Not Available

  • Soroka University Medical Center

    Bear Sheva, 8410101
    Israel

    Site Not Available

  • Soroka University Medical Centre

    Bear Sheva, 8410101
    Israel

    Site Not Available

  • Soroka University Medical Centre

    Bear-Sheva, 84101
    Israel

    Site Not Available

  • Azienda Ospedaliero Universitaria Di Cagliari

    Cagliari, 09124
    Italy

    Site Not Available

  • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

    Milano, 20122
    Italy

    Site Not Available

  • Azienda Ospedaliera di Padova

    Padova, 35020
    Italy

    Site Not Available

  • Altai State Medical University

    Barnaul, 656038
    Russian Federation

    Site Not Available

  • Chelyabinsk Regional Clinical Skin and Venereal Dispensary

    Chelyabinsk, 454048
    Russian Federation

    Site Not Available

  • Ural Scientific Research Institute of Dermatovenereology and Immunopathology

    Ekaterinburg, 620076
    Russian Federation

    Site Not Available

  • Republican Clinical Dermatology and Venerology Dispensary

    Kazan, 420012
    Russian Federation

    Site Not Available

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

    Krasnodar, 350020
    Russian Federation

    Site Not Available

  • Moscow Scientific Practical Center of Dermatology Venerology and Cosmetology

    Moscow, 119071
    Russian Federation

    Site Not Available

  • National Medical Research Center for Children Health

    Moscow, 119991
    Russian Federation

    Site Not Available

  • National Medical Research Center for Children's Health

    Moscow, 119991
    Russian Federation

    Site Not Available

  • State Scientific Center for Dermatovenereology and Cosmetology

    Moscow, 107076
    Russian Federation

    Site Not Available

  • LLC Medical Center Zdorovaya Semiya

    Novosibirsk, 630099
    Russian Federation

    Site Not Available

  • LLC PiterKlinika

    Saint Petersburg, 196158
    Russian Federation

    Site Not Available

  • Pierre Wolkenshtein Skin Diseases Clinic LLC

    Saint Petersburg, 191123
    Russian Federation

    Site Not Available

  • Saint Petersburg State Pediatric Medical University

    Saint Petersburg, 194100
    Russian Federation

    Site Not Available

  • Bashkiria State Medical University

    Ufa, 450083
    Russian Federation

    Site Not Available

  • Yarosavl State Medical Academy

    Yaroslavl, 150000
    Russian Federation

    Site Not Available

  • Hospital Sant Joan de Deu

    Esplugues de Llobregat, Cataluña 08950
    Spain

    Site Not Available

  • General University Hospital of Alicante

    Alicante, 3010
    Spain

    Site Not Available

  • Hopsital Germans Trias I Pujol

    Badalona, 08916
    Spain

    Site Not Available

  • Hopsital Germans Trias I Pujol

    Badalona (Barcelona), 08916
    Spain

    Site Not Available

  • Hospital Sant Joan de Deu

    Barcelona, 08950
    Spain

    Site Not Available

  • Hospital 12 de Octubre

    Madrid, 28041
    Spain

    Site Not Available

  • Hospital General Universitario Gregorio Maranon

    Madrid, 28007
    Spain

    Site Not Available

  • Hospital Infantil Universitario Nino Jesus

    Madrid, 28009
    Spain

    Site Not Available

  • Hospital La Paz

    Madrid, 28046
    Spain

    Site Not Available

  • Hospital Marques de Valdecilla

    Santander, 39008
    Spain

    Site Not Available

  • Phoenix Childrens Hospital

    Phoenix, Arizona 85016
    United States

    Site Not Available

  • Johnson Dermatology Clinic

    Fort Smith, Arkansas 72916
    United States

    Site Not Available

  • Research Site

    Little Rock, Arkansas 72205-7199
    United States

    Site Not Available

  • Research Site

    Fountain Valley, California 92708
    United States

    Site Not Available

  • First OC Dermatology

    Irvine, California 92697
    United States

    Site Not Available

  • Stanford University School of Medicine

    Palo Alto, California 94304
    United States

    Site Not Available

  • California Dermatology Institute

    Thousand Oaks, California 91320
    United States

    Site Not Available

  • Solutions Through Advanced Research Inc

    Jacksonville, Florida 32256
    United States

    Site Not Available

  • Ciocca Dermatology

    Miami, Florida 33173
    United States

    Site Not Available

  • Skin Care Physicians of Georgia

    Macon, Georgia 31217
    United States

    Site Not Available

  • Dawes Fretzin Dermatology Group Inc

    Indianapolis, Indiana 46256
    United States

    Site Not Available

  • Wright State Physicians

    Fairborn, Ohio 45324
    United States

    Site Not Available

  • Medical University of South Carolina

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • Driscoll Children's Hospital

    San Antonio, Texas 78218
    United States

    Site Not Available

  • Driscoll Childrens Hospital

    San Antonio, Texas 78218
    United States

    Site Not Available

  • University of Wisconsin Hospital and Clinics

    Madison, Wisconsin 53715-1375
    United States

    Site Not Available

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