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

NCT04175613 | Completed Phase 3 DMC FDA Drug

• 3 other identifiers: CC-10004-PPSO-004U1111-1242-35372019-003497-13
• Study Type: interventional
• Target: 160
• Locations: 9 countries
• Sites: 50

Brief 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.

Conditions

Psoriasis

Keywords

Plaque Psoriasis; CC-10004; Apremilast; Pediatric; Age 6 - 17 years

Outcome Measures

Primary Outcomes (6)

• Adverse Events (AEs)

  An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the subject's health, including laboratory test values, regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) should be considered an AE.

  Up to approximately 4 years

• Columbia-Suicide Severity Rating Scale (C-SSRS)

  Questionnaire to monitor depression, suicidal thoughts and behavior

  Collected at each study visit throughout the life of the study - up to 4 years

• Weight of patients treated with Apremilast

  Body weight in kg

  Collected at each study visit throughout the life of the study - up to 4 years

• Mean body mass index of the patient treated with Apremilast

  BMI (combined outcome of weight and height in the form of kg/m\^2)

  Collected at each study visit throughout the life of the study - up to 4 years

• Height patients treated with Apremilast

  Height (inches or centimeters) will be collected for all pediatric subjects and descriptively summarized

  Collected at each study visit throughout the life of the study - up to 4 years

• Assessment of sexual maturity

  Sexual maturation, assessed by Tanner staging system, will be conducted for all pediatric subjects and descriptively summarized

  Collected every 52 weeks throughout the life of the study - up to 4 years

Secondary Outcomes (1)

• Static Physician Global Assessment (sPGA)

  Collected at each study visit throughout the life of the study - up to 4 years

Study Arms (1)

Patients treated with Apremilast

EXPERIMENTAL

Subjects with a weight between 20 kg to \< 50 kg will receive apremilast 20 mg BID and subjects with weight ≥ 50 kg at Visit 1 will receive apremilast 30 mg BID. Subjects that begin the study receiving apremilast 20 mg BID and later record a body weight ≥ 50 kg, will be switched to apremilast 30 mg BID.

Drug: Apremilast

Interventions

Apremilast DRUG

Apremilast dose will be increased from 20 mg BID to 30 mg BID for those subjects that reach a weight of 50 kg or more during the study

Also known as: CC-10004, Otezla

Patients treated with Apremilast

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Subject must satisfy the following criteria to be enrolled in the study:
• 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.
• Subject must have a weight of ≥ 20 kg.
• 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.
• Subject must have completed Week 52 (Apremilast Extension Phase) of Study CC-10004-PPSO-003.
• 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.
• Subject is willing and able to adhere to the study visit schedule and other protocol requirements.
• 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;
• 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.

You may not qualify if:

• The presence of any of the following will exclude a subject from enrollment:
• 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.
• Subject has a condition that confounds the ability to interpret data from the study.
• Subject has evidence of skin conditions, other than psoriasis, that would interfere with clinical assessments.
• Subject is pregnant or breastfeeding.
• Subject has guttate, erythrodermic, or pustular psoriasis.
• Subject has active tuberculosis (TB) or a history of incompletely treated TB.
• Subject answers "Yes" to any question on the Columbia-Suicide Severity Rating Scale at Visit 16 of study CC-10004-PPSO-003.
• Subject plans concurrent use of the following therapies that may have a possible effect on psoriasis.
• 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)
• 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
• Subject has prolonged sun exposure or use of tanning booths or other ultraviolet (UV) light sources.
• 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.

Sponsors & Collaborators

• Amgen: lead

Study Sites (50)

Phoenix Childrens Hospital

Phoenix, Arizona, 85016, United States

Location

Johnson Dermatology Clinic

Fort Smith, Arkansas, 72916, United States

Location

First OC Dermatology

Irvine, California, 92697, United States

Location

Stanford University School of Medicine

Palo Alto, California, 94304, United States

Location

California Dermatology Institute

Thousand Oaks, California, 91320, United States

Location

Solutions Through Advanced Research Inc

Jacksonville, Florida, 32256, United States

Location

Ciocca Dermatology

Miami, Florida, 33173, United States

Location

Skin Care Physicians of Georgia

Macon, Georgia, 31217, United States

Location

Dawes Fretzin Dermatology Group Inc

Indianapolis, Indiana, 46256, United States

Location

Wright State Physicians

Fairborn, Ohio, 45324, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Driscoll Childrens Hospital

San Antonio, Texas, 78218, United States

Location

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, 53715-1375, United States

Location

Centre Hospitalier Universitaire Saint Pierre

Brussels, 1000, Belgium

Location

Cliniques Universitaires Saint Luc

Brussels, 1200, Belgium

Location

Universitair Ziekenhuis Gent

Ghent, 9000, Belgium

Location

Stollery Childrens Hospital

Edmonton, Alberta, T6G 2B7, Canada

Location

Winnipeg Clinic Dermatology Research

Winnipeg, Manitoba, R3C 0N2, Canada

Location

Karma Clinical Trials

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

Location

AvantDerm

Toronto, Ontario, M5A 3R6, Canada

Location

Fakultni nemocnice Kralovske Vinohrady

Prague, 100 34, Czechia

Location

Synexus Czech sro

Prague, 120 00, Czechia

Location

Cabinet du Docteur Ruer-Mulard Mireille

Martigues, 13500, France

Location

Centre Hospitalier Universitaire de Toulouse - Hopital Larrey

Toulouse, 31400, France

Location

Soroka University Medical Center

Bear Sheva, 8410101, Israel

Location

Azienda Ospedaliero Universitaria Di Cagliari

Cagliari, 09124, Italy

Location

Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

Milan, 20122, Italy

Location

Azienda Ospedaliera di Padova

Padua, 35020, Italy

Location

Altai State Medical University

Barnaul, 656038, Russia

Location

Chelyabinsk Regional Clinical Skin and Venereal Dispensary

Chelyabinsk, 454048, Russia

Location

Republican Clinical Dermatology and Venerology Dispensary

Kazan', 420012, Russia

Location

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

Krasnodar, 350020, Russia

Location

State Scientific Center for Dermatovenereology and Cosmetology

Moscow, 107076, Russia

Location

Moscow Scientific Practical Center of Dermatology Venerology and Cosmetology

Moscow, 119071, Russia

Location

National Medical Research Center for Children Health

Moscow, 119991, Russia

Location

LLC Medical Center Zdorovaya Semiya

Novosibirsk, 630099, Russia

Location

Pierre Wolkenshtein Skin Diseases Clinic LLC

Saint Petersburg, 191123, Russia

Location

Saint Petersburg State Pediatric Medical University

Saint Petersburg, 194100, Russia

Location

LLC PiterKlinika

Saint Petersburg, 196158, Russia

Location

Bashkiria State Medical University

Ufa, 450083, Russia

Location

Yarosavl State Medical Academy

Yaroslavl, 150000, Russia

Location

Ural Scientific Research Institute of Dermatovenereology and Immunopathology

Yekaterinburg, 620076, Russia

Location

Hospital Sant Joan de Deu

Esplugues de Llobregat, Catalonia, 08950, Spain

Location

General University Hospital of Alicante

Alicante, 3010, Spain

Location

Hopsital Germans Trias I Pujol

Badalona, 08916, Spain

Location

Hospital General Universitario Gregorio Maranon

Madrid, 28007, Spain

Location

Hospital Infantil Universitario Nino Jesus

Madrid, 28009, Spain

Location

Hospital 12 de Octubre

Madrid, 28041, Spain

Location

Hospital La Paz

Madrid, 28046, Spain

Location

Hospital Marques de Valdecilla

Santander, 39008, Spain

Location

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Psoriasis

Interventions

apremilast

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2019
• First Posted: November 25, 2019
• Study Start: December 20, 2019
• Primary Completion: October 30, 2025
• Study Completion: December 12, 2025
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
• Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.

Locations

RU (14); US (13); CA (4); BE (3); IL (1); CZ (2); IT (3); FR (2); ES (8)