Psoriasis Clinical Trial

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

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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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;

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:

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.

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

160

Study ID:

NCT04175613

Recruitment Status:

Active, not recruiting

Sponsor:

Amgen

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There are 50 Locations for this study

See Locations Near You

Phoenix Childrens Hospital
Phoenix Arizona, 85016, United States
Johnson Dermatology Clinic
Fort Smith Arkansas, 72916, United States
First OC Dermatology
Irvine California, 92697, United States
Stanford University School of Medicine
Palo Alto California, 94304, United States
California Dermatology Institute
Thousand Oaks California, 91320, United States
Solutions Through Advanced Research Inc
Jacksonville Florida, 32256, United States
Ciocca Dermatology
Miami Florida, 33173, United States
Skin Care Physicians of Georgia
Macon Georgia, 31217, United States
Dawes Fretzin Dermatology Group Inc
Indianapolis Indiana, 46256, United States
Wright State Physicians
Fairborn Ohio, 45324, United States
Medical University of South Carolina
Charleston South Carolina, 29425, United States
Driscoll Children's Hospital
San Antonio Texas, 78218, United States
University of Wisconsin Hospital and Clinics
Madison Wisconsin, 53715, United States
Centre Hospitalier Universitaire Saint Pierre
Brussels , 1000, Belgium
Cliniques Universitaires Saint Luc
Brussels , 1200, Belgium
Universitair Ziekenhuis Gent
Gent , 9000, Belgium
Stollery Children's Hospital
Edmonton Alberta, T6G 2, Canada
Winnipeg Clinic Dermatology Research
Winnipeg Manitoba, R3C 0, Canada
Karma Clinical Trials
St. John's Newfoundland and Labrador, A1C 2, Canada
AvantDerm
Toronto Ontario, M5A 3, Canada
Fakultni nemocnice Kralovske Vinohrady
Praha 10 , 100 3, Czechia
Synexus Czech sro
Praha , 120 0, Czechia
Cabinet du Docteur Ruer-Mulard Mireille
Martigues , 13500, France
Centre Hospitalier Universitaire de Toulouse - Hopital Larrey
Toulouse , 31000, France
Soroka University Medical Centre
Bear Sheva , 84101, Israel
Azienda Ospedaliero Universitaria Di Cagliari
Cagliari , 09124, Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Milano , 20122, Italy
Azienda Ospedaliera di Padova
Padova , 35020, Italy
Altai State Medical University
Barnaul , 65603, Russian Federation
Chelyabinsk Regional Clinical Skin and Venereal Dispensary
Chelyabinsk , 45404, Russian Federation
Ural Scientific Research Institute of Dermatovenereology and Immunopathology
Ekaterinburg , 62007, Russian Federation
Republican Clinical Dermatology and Venerology Dispensary
Kazan , 42001, Russian Federation
Clinical Dispensary of Dermatology and Venereology of Krasnodar Territory of the Ministry of Health
Krasnodar , 35002, Russian Federation
State Scientific Center for Dermatovenereology and Cosmetology
Moscow , 10707, Russian Federation
Moscow Scientific Practical Center of Dermatology Venerology and Cosmetology
Moscow , 11907, Russian Federation
National Medical Research Center for Children's Health
Moscow , 11999, Russian Federation
LLC Medical Center Zdorovaya Semiya
Novosibirsk , 63009, Russian Federation
Pierre Wolkenshtein Skin Diseases Clinic LLC
Saint Petersburg , 19112, Russian Federation
Saint Petersburg State Pediatric Medical University
Saint Petersburg , 19410, Russian Federation
LLC PiterKlinika
Saint Petersburg , 19615, Russian Federation
Bashkiria State Medical University
Ufa , 45008, Russian Federation
Yarosavl State Medical Academy
Yaroslavl , 15000, Russian Federation
Hospital Sant Joan de Deu
Esplugues de Llobregat Cataluña, 08950, Spain
General University Hospital of Alicante
Alicante , 3010, Spain
Hopsital Germans Trias I Pujol
Badalona , 08916, Spain
Hospital General Universitario Gregorio Maranon
Madrid , 28007, Spain
Hospital Infantil Universitario Nino Jesus
Madrid , 28009, Spain
Hospital 12 de Octubre
Madrid , 28041, Spain
Hospital La Paz
Madrid , 28046, Spain
Hospital Marques de Valdecilla
Santander , 39008, Spain

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

160

Study ID:

NCT04175613

Recruitment Status:

Active, not recruiting

Sponsor:


Amgen

How clear is this clinincal trial information?

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