Phase
Condition
Warts
Rosacea
Scalp Disorders
Treatment
Apremilast
Clinical Study ID
Ages 6-17 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 informedconsent 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 5thpercentile on the Centers for Disease Control (CDC) growth chart for children andadolescents.
Subject must have completed Week 52 (Apremilast Extension Phase) of StudyCC-10004-PPSO-003.
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.
Subject is willing and able to adhere to the study visit schedule and other protocolrequirements.
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:
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.
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 interferewith 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 Scaleat Visit 16 of study CC-10004-PPSO-003.
Subject plans concurrent use of the following therapies that may have a possibleeffect on psoriasis.
Conventional systemic therapy for psoriasis (including but not limited tocyclosporine, corticosteroids, methotrexate, oral retinoids, mycophenolate,thioguanine, hydroxyurea, sirolimus, sulfasalazine, azathioprine, and fumaricacid esters)
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
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 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
Connect with a study center
Centre Hospitalier Universitaire Saint Pierre
Brussels, 1000
BelgiumSite Not Available
Cliniques Universitaires Saint Luc
Brussels, 1200
BelgiumSite Not Available
Universitair Ziekenhuis Gent
Gent, 9000
BelgiumSite Not Available
Stollery Children's Hospital
Edmonton, Alberta T6G 2B7
CanadaSite Not Available
Stollery Childrens Hospital
Edmonton, Alberta T6G 2B7
CanadaSite Not Available
Winnipeg Clinic Dermatology Research
Winnipeg, Manitoba R3C 0N2
CanadaSite Not Available
Karma Clinical Trials
St. John's, Newfoundland and Labrador A1C 2H5
CanadaSite Not Available
AvantDerm
Toronto, Ontario M5A 3R6
CanadaSite Not Available
Synexus Czech sro
Praha, 120 00
CzechiaSite Not Available
Fakultni nemocnice Kralovske Vinohrady
Praha 10, 100 34
CzechiaSite Not Available
Cabinet du Docteur Ruer-Mulard Mireille
Martigues, 13500
FranceSite Not Available
Centre Hospitalier Universitaire de Toulouse - Hopital Larrey
Toulouse, 31400
FranceSite Not Available
Soroka University Medical Center
Bear Sheva, 8410101
IsraelSite Not Available
Soroka University Medical Centre
Bear Sheva, 8410101
IsraelSite Not Available
Soroka University Medical Centre
Bear-Sheva, 84101
IsraelSite Not Available
Azienda Ospedaliero Universitaria Di Cagliari
Cagliari, 09124
ItalySite Not Available
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Milano, 20122
ItalySite Not Available
Azienda Ospedaliera di Padova
Padova, 35020
ItalySite Not Available
Altai State Medical University
Barnaul, 656038
Russian FederationSite Not Available
Chelyabinsk Regional Clinical Skin and Venereal Dispensary
Chelyabinsk, 454048
Russian FederationSite Not Available
Ural Scientific Research Institute of Dermatovenereology and Immunopathology
Ekaterinburg, 620076
Russian FederationSite Not Available
Republican Clinical Dermatology and Venerology Dispensary
Kazan, 420012
Russian FederationSite Not Available
Clinical Dispensary of Dermatology and Venereology of Krasnodar Territory of the Ministry of Health
Krasnodar, 350020
Russian FederationSite Not Available
Moscow Scientific Practical Center of Dermatology Venerology and Cosmetology
Moscow, 119071
Russian FederationSite Not Available
National Medical Research Center for Children Health
Moscow, 119991
Russian FederationSite Not Available
National Medical Research Center for Children's Health
Moscow, 119991
Russian FederationSite Not Available
State Scientific Center for Dermatovenereology and Cosmetology
Moscow, 107076
Russian FederationSite Not Available
LLC Medical Center Zdorovaya Semiya
Novosibirsk, 630099
Russian FederationSite Not Available
LLC PiterKlinika
Saint Petersburg, 196158
Russian FederationSite Not Available
Pierre Wolkenshtein Skin Diseases Clinic LLC
Saint Petersburg, 191123
Russian FederationSite Not Available
Saint Petersburg State Pediatric Medical University
Saint Petersburg, 194100
Russian FederationSite Not Available
Bashkiria State Medical University
Ufa, 450083
Russian FederationSite Not Available
Yarosavl State Medical Academy
Yaroslavl, 150000
Russian FederationSite Not Available
Hospital Sant Joan de Deu
Esplugues de Llobregat, Cataluña 08950
SpainSite Not Available
General University Hospital of Alicante
Alicante, 3010
SpainSite Not Available
Hopsital Germans Trias I Pujol
Badalona, 08916
SpainSite Not Available
Hopsital Germans Trias I Pujol
Badalona (Barcelona), 08916
SpainSite Not Available
Hospital Sant Joan de Deu
Barcelona, 08950
SpainSite Not Available
Hospital 12 de Octubre
Madrid, 28041
SpainSite Not Available
Hospital General Universitario Gregorio Maranon
Madrid, 28007
SpainSite Not Available
Hospital Infantil Universitario Nino Jesus
Madrid, 28009
SpainSite Not Available
Hospital La Paz
Madrid, 28046
SpainSite Not Available
Hospital Marques de Valdecilla
Santander, 39008
SpainSite Not Available
Phoenix Childrens Hospital
Phoenix, Arizona 85016
United StatesSite Not Available
Johnson Dermatology Clinic
Fort Smith, Arkansas 72916
United StatesSite Not Available
Research Site
Little Rock, Arkansas 72205-7199
United StatesSite Not Available
Research Site
Fountain Valley, California 92708
United StatesSite Not Available
First OC Dermatology
Irvine, California 92697
United StatesSite Not Available
Stanford University School of Medicine
Palo Alto, California 94304
United StatesSite Not Available
California Dermatology Institute
Thousand Oaks, California 91320
United StatesSite Not Available
Solutions Through Advanced Research Inc
Jacksonville, Florida 32256
United StatesSite Not Available
Ciocca Dermatology
Miami, Florida 33173
United StatesSite Not Available
Skin Care Physicians of Georgia
Macon, Georgia 31217
United StatesSite Not Available
Dawes Fretzin Dermatology Group Inc
Indianapolis, Indiana 46256
United StatesSite Not Available
Wright State Physicians
Fairborn, Ohio 45324
United StatesSite Not Available
Medical University of South Carolina
Charleston, South Carolina 29425
United StatesSite Not Available
Driscoll Children's Hospital
San Antonio, Texas 78218
United StatesSite Not Available
Driscoll Childrens Hospital
San Antonio, Texas 78218
United StatesSite Not Available
University of Wisconsin Hospital and Clinics
Madison, Wisconsin 53715-1375
United StatesSite Not Available
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