Phase
Condition
Warts
Scalp Disorders
Rash
Treatment
Apremilast (CC-10004)
Placebo
Clinical Study ID
Ages 6-17 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Males or female subjects 6 to 17 years of age, inclusive, at the time the informedconsent form is signed by the legal guardian
Subjects must have a weight of ≥ 20 kg
Diagnosis of chronic plaque psoriasis for at least 6 months prior to Screening.
Has moderate to severe plaque psoriasis at Screening and Baseline as defined by:
PASI score ≥ 12; and
Body surface area (BSA) ≥ 10%; and
sPGA ≥ 3 (moderate to severe)
Disease inadequately controlled by or inappropriate for topical therapy forpsoriasis
Candidate for systemic therapy or phototherapy
Exclusion
Exclusion Criteria:
Guttate, erythrodermic, or pustular psoriasis at Screening and Baseline
Psoriasis flare or rebound within 4 weeks prior to Screening
Prior history of suicide attempt at any time in the subject's lifetime prior toScreening or randomization in the study, or major psychiatric illness requiringhospitalization within 3 years prior to signing the assent and informed consent
Answer "Yes" to any question on the Columbia-Suicide Severity Rating Scale duringScreening or at Baseline
Current or planned concurrent use of the following therapies that may have apossible effect on psoriasis a. Topical therapy within 2 weeks prior to randomization (including but not limitedto topical corticosteroids, topical retinoid or vitamin D analog preparations,tacrolimus, pimecrolimus, or anthralin/dithranol) Exceptions*: i. Low potency or weak corticosteroids (please refer to the Investigators' Manual)will be allowed as background therapy for treatment of the face, axillae and groinin accordance with manufacturer's suggested usage ii. Unmedicated skin moisturizer (eg, Eucerin®) will also be permitted for body lesions
*Subjects should not use these topical treatments within 24 hours prior to theclinic visit. b. Conventional systemic therapy for psoriasis within 4 weeks prior to randomizationc. Phototherapy treatment (ie, ultraviolet B [UVB], PUVA) within 4 weeks prior torandomization d. Biologic therapy within 4 weeks prior to randomization or 5 PK/PDhalf-lives (whichever is longer).
Study Design
Study Description
Connect with a study center
Centre Hospitalier Universitaire Saint Pierre
Brussels, 1000
BelgiumSite Not Available
Cliniques Universitaires St Luc
Bruxelles, 1200
BelgiumSite Not Available
Universitair Ziekenhuis Gent
Gent, 9000
BelgiumSite Not Available
Kirk Barber Research
Calgary, Alberta T2G 1B1
CanadaSite Not Available
Stollery Children's Hospital
Edmonton, Alberta T6G 2B7
CanadaSite Not Available
Enverus Medical Research
Surrey, British Columbia V3R 6A7
CanadaSite Not Available
Winnipeg Clinic Dermatology Research
Winnipeg, Manitoba R3C 0N2
CanadaSite Not Available
Karma Clinical Trials
Saint John's, Newfoundland and Labrador A1A 4Y3
CanadaSite Not Available
Research Site
St. John's, Newfoundland and Labrador A1A 5E8
CanadaSite Not Available
AvantDerm
Toronto, Ontario M5A 3R6
CanadaSite Not Available
CHU Saint-Justine
Montreal, Quebec H3T 1C5
CanadaSite Not Available
Skin Care Centre
Vancouver, V5Z 4E8
CanadaSite Not Available
Fakultni nemocnice Hradec Kralove
Hradec Kralove, 500 05
CzechiaSite Not Available
Fakultni nemocnice Kralovske Vinohrady
Prague 10, 100 34
CzechiaSite Not Available
Synexus Czech sro
Praha, 120 00
CzechiaSite Not Available
Fakultni nemocnice Kralovske Vinohrady
Praha 1, 110 00
CzechiaSite Not Available
Research Site
Praha 10, 100 34
CzechiaSite Not Available
Centre Hospitalier Victor Dupouy Argenteuil
Argenteuil, 95107
FranceSite Not Available
Centre Hospitalier Victor Dupouy Argenteuil
Argenteuil CEDEX, 95107
FranceSite Not Available
Research Site
Bron, 69500
FranceSite Not Available
Centre Hospitalier Universitaire Lyon
Bron cedex, 69677
FranceSite Not Available
Cabinet du Docteur Ruer-Mulard Mireille
Martigues, 13500
FranceSite Not Available
Hotel Dieu CHU Nantes
Nantes, 44093
FranceSite Not Available
Research Site
Nantes Cedex 01, 44093
FranceSite Not Available
Centre Hospitalier Universitaire de Nice
Nice, 06202
FranceSite Not Available
Centre Hospitalier Universitaire de Nice - Hopital L'Archet
Nice CEDEX 3, 06202
FranceSite Not Available
Hopital Necker
Paris Cedex 15, 75015
FranceSite Not Available
Centre Hospitalier de Cornouaille - Hopital Laennec
Quimper, 29018
FranceSite Not Available
CHU Saint Etienne Hopital Nord
Saint Etienne, 42055
FranceSite Not Available
Research Site
Saint Priest en Jarez, 42270
FranceSite Not Available
CHU Saint Etienne Hopital Nord
Saint-Priest En Jarrez, 42055
FranceSite Not Available
CHU Saint Etienne Hopital Nord
Saint-Priest-en-Jarez, 42055
FranceSite Not Available
Research Site
Saint-Étienne, 42055
FranceSite Not Available
Centre Hospitalier Universitaire de Toulouse - Hopital Larrey
Toulouse Cedex 9, 31059
FranceSite Not Available
Centre Hospitalier de Valence
Valence, 26000
FranceSite Not Available
Charite - Campus Mitte
Berlin, 10117
GermanySite Not Available
Universitatsklinikum Carl Gustav Carus
Dresden, 01307
GermanySite Not Available
Universitaetsklinikum Erlangen
Erlangen, 91052
GermanySite Not Available
Klinikum der Johann Wolfgang Goethe Universitat
Frankfurt am Main, 60590
GermanySite Not Available
Praxis Dr. med S. Rotterdam
Gelsenkirchen, 45883
GermanySite Not Available
Universitaetsklinik Hamburg - Eppendorf
Hamburg, 20246
GermanySite Not Available
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
Mainz, 55131
GermanySite Not Available
Universitatsklinikum Muenster
Munster, 48149
GermanySite Not Available
University of Tubingen
Tübingen, 72076
GermanySite Not Available
Universitaetsklinikum Wuerzburg
Wuerzburg, 97080
GermanySite Not Available
Debreceni Egyetem Klinikai Kozpont
Debrecen, 4032
HungarySite Not Available
Somogy Megyei Kaposi Mor Oktato Korhaz
Kaposvar, 7400
HungarySite Not Available
Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz
Miskolc, 3526
HungarySite Not Available
Szegedi Tudomanyegyetem - Szent-Gyorgyi Albert Klinikai Kozpont
Szeged, 6720
HungarySite Not Available
Veszprem Megyei Csolnoky Ferenc Korhaz-Rendelointezet
Veszprém, 8200
HungarySite Not Available
Soroka University Medical Center
Bear-Sheva, 84101
IsraelSite Not Available
Research Site
Beer-Sheva, 8410101
IsraelSite Not Available
Chaim Sheba Medical Center
Ramat Gan, 5262000
IsraelSite Not Available
Azienda Ospedaliero Universitaria Di Bologna Policlinico S Orsola Malpighi
Bologna, 40138
ItalySite Not Available
Azienda Ospedaliero Universitaria Di Cagliari
Caglari, 09124
ItalySite Not Available
Azienda Ospedaliera Universitaria di Cagliari
Cagliari, 09124
ItalySite Not Available
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Milano, 20122
ItalySite Not Available
Azienda Ospedaliera Universitaria Federico II
Napoli, 80131
ItalySite Not Available
Research Site
Napoli, Campania, 80131
ItalySite Not Available
Azienda Ospedaliera di Padova
Padova, 35128
ItalySite Not Available
Azienda Ospedaliera di Reggio Emilia Arcispedale Santa Maria Nuova
Reggio Emilia, 42123
ItalySite Not Available
Istituto Dermatologico San Gallicano IRCCS Dermatologia Clinica
Roma, 00144
ItalySite Not Available
Policlinico Tor Vergata
Roma, 00133
ItalySite Not Available
Istituto Dermatologico San Gallicano IRCCS Dermatologia Clinica
Rome, 00144
ItalySite Not Available
Derma-Norte
Bosques Del Prado Sur, 20127
MexicoSite Not Available
Centro Multidisciplinario para el Desarrollo Especializado de la Investigacion Clinica en Yucatan S
Merida, 97130
MexicoSite Not Available
Hospital Infantil de Mexico Federico Gomez
Mexico, 06720
MexicoSite Not Available
Hospital Universitario "Dr. Jose E. Gonzalez"
Monterrey, 64460
MexicoSite Not Available
Radboud university medical center
NIjmegen,
NetherlandsSite Not Available
Altai State Medical University
Barnaul, 656038
Russian FederationSite Not Available
Chelyabinsk Regional Clinical Skin and Venereal Dispensary
Chelyabinsk, 454092
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, 420004
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's Health
Moscow, 119991
Russian FederationSite Not Available
Russian Children's Clinical Hospital
Moscow, 117997
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
Skin Disease Clinic if Pier Wolkenstein, LLC
Saint Peresburg, 191123
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 Petesburg, 194100
Russian FederationSite Not Available
Saratov State Medical University
Saratov, 410028
Russian FederationSite Not Available
Bashkiria State Medical University
Ufa, 450008
Russian FederationSite Not Available
Yarosavl State Medical Academy
Yaroslavl, 150000
Russian FederationSite Not Available
Hospital Marques de Valdecilla
Santander, Cantabria 39008
SpainSite Not Available
Hospital General Universitario de Alicante
Alicante, Comunidad Valenciana 03010
SpainSite Not Available
Hospital Universitari Germans Trias i Pujol Can Ruti
Badalona, 08916
SpainSite Not Available
Research Site
Badalona (Barcelona), 08916
SpainSite Not Available
Hospital Sant Joan de Deu
Barcelona, 08950
SpainSite Not Available
Hospital Puerta del Mar
Cadiz, 11009
SpainSite Not Available
Hospital Universitario Reina Sofia
Cordoba, 14001
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
Complexo Hospitalario De Pontevedra
Pontevedra, 36001
SpainSite Not Available
Hospital Marques de Valdecilla
Satander, 39008
SpainSite Not Available
Hospital Universitario Virgen del Rocio - PPDS
Sevilla, 41013
SpainSite Not Available
University of Alabama Birmingham
Birmingham, Alabama 35233
United StatesSite Not Available
Phoenix Childrens Hospital
Phoenix, Arizona 85016
United StatesSite Not Available
Johnson Dermatology Clinic
Fort Smith, Arkansas 72916
United StatesSite Not Available
Zenith Research Inc.
Beverly Hills, California 90212
United StatesSite Not Available
First OC Dermatology
Fountain Valley, California 92708
United StatesSite Not Available
Avance Clinical Trials
Laguna Niguel, California 92677
United StatesSite Not Available
Stanford University
Palo Alto, California 94304
United StatesSite Not Available
Coastal Family Dermatology
San Luis Obispo, California 93401
United StatesSite Not Available
University of California Los Angeles
Santa Monica, California 90404
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
Glick Skin Institute Clinical Research
Margate, Florida 33063
United StatesSite Not Available
Ciocca Dermatology
Miami, Florida 33173
United StatesSite Not Available
University of Miami Hospital
Miami, Florida 33136
United StatesSite Not Available
University of South Florida Health Morsani Center for Advanced Healthcare
Tampa, Florida 33612-4742
United StatesSite Not Available
Skin Care Physicians of Georgia
Macon, Georgia 31217
United StatesSite Not Available
Treasure Valley Medical Research
Meridian, Idaho 83646
United StatesSite Not Available
DeNova Research
Chicago, Illinois 60602
United StatesSite Not Available
Dawes Fretzin Dermatology Group Inc
Indianapolis, Indiana 46256
United StatesSite Not Available
Epiphany Dermatology of Kansas, LLC
Overland Park, Kansas 66210
United StatesSite Not Available
ActivMed Practices and Research Inc
Beverly, Massachusetts 01915
United StatesSite Not Available
Mayo Clinic
Rochester, Minnesota 55905
United StatesSite Not Available
J Woodson Dermatology and Associates Ltd
Henderson, Nevada 89052
United StatesSite Not Available
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire 03756
United StatesSite Not Available
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire 03766
United StatesSite Not Available
Montefiore Medical Center
Bronx, New York 10467
United StatesSite Not Available
SUNY Downstate Medical Center
Brooklyn, New York 11203
United StatesSite Not Available
Forest Hills Dermatology Group
Forest Hills, New York 11375
United StatesSite Not Available
SUNY Downstate Medical Center
Manhasset, New York 11030
United StatesSite Not Available
Cincinnati Childrens Hospital Medical Center
Cincinnati, Ohio 45229
United StatesSite Not Available
Wright State Physicians
Fairborn, Ohio 45324
United StatesSite Not Available
Essential Medical Research, LLC
Tulsa, Oklahoma 74137
United StatesSite Not Available
Medical University of South Carolina
Charleston, South Carolina 29425
United StatesSite Not Available
Arlington Research Center
Arlington, Texas 76011
United StatesSite Not Available
Driscoll Childrens Hospital
Corpus Christi, Texas 78411
United StatesSite Not Available
Modern Research Associates PLLC
Dallas, Texas 75231
United StatesSite Not Available
Mosaic Dermatology
Houston, Texas 77065
United StatesSite Not Available
Texas Dermatology and Laser Specialists
San Antonio, Texas 78218
United StatesSite Not Available
Jordan Valley Dermatology Center
West Jordan, Utah 84088
United StatesSite Not Available
MercyHealth East
Janesville, Wisconsin 53546
United StatesSite Not Available
University of Wisconsin Hospital and Clinics
Madison, Wisconsin 53715
United StatesSite Not Available
Childrens Hospital of Wisconsin
Milwaukee, Wisconsin 53226
United StatesSite Not Available
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