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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 6 Years - 17 Years
Gender All
More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04175613
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Amgen
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

MD
Principal Investigator Affiliation Amgen
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Active, not recruiting
Countries Belgium, Canada, Czechia, France, Israel, Italy, Russian Federation, Spain, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Psoriasis
Study Website: View Trial Website
Arms & Interventions

Arms

Experimental: Patients treated with Apremilast

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.

Interventions

Drug: - Apremilast

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Phoenix Childrens Hospital, Phoenix, Arizona

Status

Address

Phoenix Childrens Hospital

Phoenix, Arizona, 85016

Johnson Dermatology Clinic, Fort Smith, Arkansas

Status

Address

Johnson Dermatology Clinic

Fort Smith, Arkansas, 72916

First OC Dermatology, Irvine, California

Status

Address

First OC Dermatology

Irvine, California, 92697

Stanford University School of Medicine, Palo Alto, California

Status

Address

Stanford University School of Medicine

Palo Alto, California, 94304

California Dermatology Institute, Thousand Oaks, California

Status

Address

California Dermatology Institute

Thousand Oaks, California, 91320

Solutions Through Advanced Research Inc, Jacksonville, Florida

Status

Address

Solutions Through Advanced Research Inc

Jacksonville, Florida, 32256

Ciocca Dermatology, Miami, Florida

Status

Address

Ciocca Dermatology

Miami, Florida, 33173

Skin Care Physicians of Georgia, Macon, Georgia

Status

Address

Skin Care Physicians of Georgia

Macon, Georgia, 31217

Dawes Fretzin Dermatology Group Inc, Indianapolis, Indiana

Status

Address

Dawes Fretzin Dermatology Group Inc

Indianapolis, Indiana, 46256

Wright State Physicians, Fairborn, Ohio

Status

Address

Wright State Physicians

Fairborn, Ohio, 45324

Medical University of South Carolina, Charleston, South Carolina

Status

Address

Medical University of South Carolina

Charleston, South Carolina, 29425

Driscoll Children's Hospital, San Antonio, Texas

Status

Address

Driscoll Children's Hospital

San Antonio, Texas, 78218

Madison, Wisconsin

Status

Address

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, 53715-1375

International Sites

Brussels, Belgium

Status

Address

Centre Hospitalier Universitaire Saint Pierre

Brussels, , 1000

Cliniques Universitaires Saint Luc, Brussels, Belgium

Status

Address

Cliniques Universitaires Saint Luc

Brussels, , 1200

Universitair Ziekenhuis Gent, Gent, Belgium

Status

Address

Universitair Ziekenhuis Gent

Gent, , 9000

Stollery Childrens Hospital, Edmonton, Alberta, Canada

Status

Address

Stollery Childrens Hospital

Edmonton, Alberta, T6G 2B7

Winnipeg Clinic Dermatology Research, Winnipeg, Manitoba, Canada

Status

Address

Winnipeg Clinic Dermatology Research

Winnipeg, Manitoba, R3C 0N2

Karma Clinical Trials, St. John's, Newfoundland and Labrador, Canada

Status

Address

Karma Clinical Trials

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

AvantDerm, Toronto, Ontario, Canada

Status

Address

AvantDerm

Toronto, Ontario, M5A 3R6

Fakultni nemocnice Kralovske Vinohrady, Praha 10, Czechia

Status

Address

Fakultni nemocnice Kralovske Vinohrady

Praha 10, , 100 34

Synexus Czech sro, Praha, Czechia

Status

Address

Synexus Czech sro

Praha, , 120 00

Cabinet du Docteur Ruer-Mulard Mireille, Martigues, France

Status

Address

Cabinet du Docteur Ruer-Mulard Mireille

Martigues, , 13500

Toulouse, France

Status

Address

Centre Hospitalier Universitaire de Toulouse - Hopital Larrey

Toulouse, , 31000

Soroka University Medical Center, Bear Sheva, Israel

Status

Address

Soroka University Medical Center

Bear Sheva, , 8410101

Cagliari, Italy

Status

Address

Azienda Ospedaliero Universitaria Di Cagliari

Cagliari, , 09124

Milano, Italy

Status

Address

Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

Milano, , 20122

Azienda Ospedaliera di Padova, Padova, Italy

Status

Address

Azienda Ospedaliera di Padova

Padova, , 35020

Altai State Medical University, Barnaul, Russian Federation

Status

Address

Altai State Medical University

Barnaul, , 656038

Chelyabinsk, Russian Federation

Status

Address

Chelyabinsk Regional Clinical Skin and Venereal Dispensary

Chelyabinsk, , 454048

Ekaterinburg, Russian Federation

Status

Address

Ural Scientific Research Institute of Dermatovenereology and Immunopathology

Ekaterinburg, , 620076

Kazan, Russian Federation

Status

Address

Republican Clinical Dermatology and Venerology Dispensary

Kazan, , 420012

Krasnodar, Russian Federation

Status

Address

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

Krasnodar, , 350020

Moscow, Russian Federation

Status

Address

State Scientific Center for Dermatovenereology and Cosmetology

Moscow, , 107076

Moscow, Russian Federation

Status

Address

Moscow Scientific Practical Center of Dermatology Venerology and Cosmetology

Moscow, , 119071

Moscow, Russian Federation

Status

Address

National Medical Research Center for Children Health

Moscow, , 119991

LLC Medical Center Zdorovaya Semiya, Novosibirsk, Russian Federation

Status

Address

LLC Medical Center Zdorovaya Semiya

Novosibirsk, , 630099

Saint Petersburg, Russian Federation

Status

Address

Pierre Wolkenshtein Skin Diseases Clinic LLC

Saint Petersburg, , 191123

Saint Petersburg, Russian Federation

Status

Address

Saint Petersburg State Pediatric Medical University

Saint Petersburg, , 194100

LLC PiterKlinika, Saint Petersburg, Russian Federation

Status

Address

LLC PiterKlinika

Saint Petersburg, , 196158

Bashkiria State Medical University, Ufa, Russian Federation

Status

Address

Bashkiria State Medical University

Ufa, , 450083

Yarosavl State Medical Academy, Yaroslavl, Russian Federation

Status

Address

Yarosavl State Medical Academy

Yaroslavl, , 150000

Hospital Sant Joan de Deu, Esplugues de Llobregat, Cataluña, Spain

Status

Address

Hospital Sant Joan de Deu

Esplugues de Llobregat, Cataluña, 08950

General University Hospital of Alicante, Alicante, Spain

Status

Address

General University Hospital of Alicante

Alicante, , 3010

Hopsital Germans Trias I Pujol, Badalona, Spain

Status

Address

Hopsital Germans Trias I Pujol

Badalona, , 08916

Madrid, Spain

Status

Address

Hospital General Universitario Gregorio Maranon

Madrid, , 28007

Madrid, Spain

Status

Address

Hospital Infantil Universitario Nino Jesus

Madrid, , 28009

Hospital 12 de Octubre, Madrid, Spain

Status

Address

Hospital 12 de Octubre

Madrid, , 28041

Hospital La Paz, Madrid, Spain

Status

Address

Hospital La Paz

Madrid, , 28046

Hospital Marques de Valdecilla, Santander, Spain

Status

Address

Hospital Marques de Valdecilla

Santander, , 39008

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