Efficacy and Safety Study of Apremilast (CC-10004) in Pediatric Subjects From 6 Through 17 Years of Age With Moderate to Severe Plaque Psoriasis

Last updated: December 13, 2024
Sponsor: Amgen
Overall Status: Completed

Phase

3

Condition

Warts

Scalp Disorders

Rash

Treatment

Apremilast (CC-10004)

Placebo

Clinical Study ID

NCT03701763
CC-10004-PPSO-003
2018-002918-12
U1111-1219-3112
  • Ages 6-17
  • All Genders

Study Summary

This is a Phase 3, multicenter, randomized, placebo-controlled, double-blind study of the efficacy and safety of apremilast (CC-10004) in pediatric subjects with moderate to severe plaque psoriasis.

At least 230 pediatric subjects (ages 6 through 17 years) will be randomized 2:1 to receive either apremilast or placebo for the first 16 weeks and then all subjects will receive apremilast during the 36 week Extension Phase for a total of 52 weeks. Randomization to apremilast arm or placebo arm will be stratified by age group (6 to 11 years or 12 to 17 years). Subjects will receive apremilast treatment of either 20 mg twice daily (BID) or 30 mg BID, depending on weight. This Phase 3 study is being conducted to evaluate the safety and efficacy of apremilast in the treatment of pediatric subjects.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Males or female subjects 6 to 17 years of age, inclusive, at the time the informedconsent form is signed by the legal guardian

  2. Subjects must have a weight of ≥ 20 kg

  3. Diagnosis of chronic plaque psoriasis for at least 6 months prior to Screening.

  4. 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)

  1. Disease inadequately controlled by or inappropriate for topical therapy forpsoriasis

  2. Candidate for systemic therapy or phototherapy

Exclusion

Exclusion Criteria:

  1. Guttate, erythrodermic, or pustular psoriasis at Screening and Baseline

  2. Psoriasis flare or rebound within 4 weeks prior to Screening

  3. 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

  4. Answer "Yes" to any question on the Columbia-Suicide Severity Rating Scale duringScreening or at Baseline

  5. 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

Total Participants: 245
Treatment Group(s): 2
Primary Treatment: Apremilast (CC-10004)
Phase: 3
Study Start date:
December 19, 2018
Estimated Completion Date:
March 27, 2023

Study Description

Treatment will be assigned by weight with subjects 20 kg to < 50 kg receiving apremilast 20 mg BID or placebo BID and subjects ≥ 50 kg receiving apremilast 30 mg BID or placebo BID. Total study duration is up to 71 weeks. Subjects completing all 52 weeks of the treatment and extension phase will be able to enter the Long-term study. Subjects not entering the Long-term study will return for 3 observational follow-up visits, 4, 8 and 14 weeks after last dose of study drug.

Connect with a study center

  • Centre Hospitalier Universitaire Saint Pierre

    Brussels, 1000
    Belgium

    Site Not Available

  • Cliniques Universitaires St Luc

    Bruxelles, 1200
    Belgium

    Site Not Available

  • Universitair Ziekenhuis Gent

    Gent, 9000
    Belgium

    Site Not Available

  • Kirk Barber Research

    Calgary, Alberta T2G 1B1
    Canada

    Site Not Available

  • Stollery Children's Hospital

    Edmonton, Alberta T6G 2B7
    Canada

    Site Not Available

  • Enverus Medical Research

    Surrey, British Columbia V3R 6A7
    Canada

    Site Not Available

  • Winnipeg Clinic Dermatology Research

    Winnipeg, Manitoba R3C 0N2
    Canada

    Site Not Available

  • Karma Clinical Trials

    Saint John's, Newfoundland and Labrador A1A 4Y3
    Canada

    Site Not Available

  • Research Site

    St. John's, Newfoundland and Labrador A1A 5E8
    Canada

    Site Not Available

  • AvantDerm

    Toronto, Ontario M5A 3R6
    Canada

    Site Not Available

  • CHU Saint-Justine

    Montreal, Quebec H3T 1C5
    Canada

    Site Not Available

  • Skin Care Centre

    Vancouver, V5Z 4E8
    Canada

    Site Not Available

  • Fakultni nemocnice Hradec Kralove

    Hradec Kralove, 500 05
    Czechia

    Site Not Available

  • Fakultni nemocnice Kralovske Vinohrady

    Prague 10, 100 34
    Czechia

    Site Not Available

  • Synexus Czech sro

    Praha, 120 00
    Czechia

    Site Not Available

  • Fakultni nemocnice Kralovske Vinohrady

    Praha 1, 110 00
    Czechia

    Site Not Available

  • Research Site

    Praha 10, 100 34
    Czechia

    Site Not Available

  • Centre Hospitalier Victor Dupouy Argenteuil

    Argenteuil, 95107
    France

    Site Not Available

  • Centre Hospitalier Victor Dupouy Argenteuil

    Argenteuil CEDEX, 95107
    France

    Site Not Available

  • Research Site

    Bron, 69500
    France

    Site Not Available

  • Centre Hospitalier Universitaire Lyon

    Bron cedex, 69677
    France

    Site Not Available

  • Cabinet du Docteur Ruer-Mulard Mireille

    Martigues, 13500
    France

    Site Not Available

  • Hotel Dieu CHU Nantes

    Nantes, 44093
    France

    Site Not Available

  • Research Site

    Nantes Cedex 01, 44093
    France

    Site Not Available

  • Centre Hospitalier Universitaire de Nice

    Nice, 06202
    France

    Site Not Available

  • Centre Hospitalier Universitaire de Nice - Hopital L'Archet

    Nice CEDEX 3, 06202
    France

    Site Not Available

  • Hopital Necker

    Paris Cedex 15, 75015
    France

    Site Not Available

  • Centre Hospitalier de Cornouaille - Hopital Laennec

    Quimper, 29018
    France

    Site Not Available

  • CHU Saint Etienne Hopital Nord

    Saint Etienne, 42055
    France

    Site Not Available

  • Research Site

    Saint Priest en Jarez, 42270
    France

    Site Not Available

  • CHU Saint Etienne Hopital Nord

    Saint-Priest En Jarrez, 42055
    France

    Site Not Available

  • CHU Saint Etienne Hopital Nord

    Saint-Priest-en-Jarez, 42055
    France

    Site Not Available

  • Research Site

    Saint-Étienne, 42055
    France

    Site Not Available

  • Centre Hospitalier Universitaire de Toulouse - Hopital Larrey

    Toulouse Cedex 9, 31059
    France

    Site Not Available

  • Centre Hospitalier de Valence

    Valence, 26000
    France

    Site Not Available

  • Charite - Campus Mitte

    Berlin, 10117
    Germany

    Site Not Available

  • Universitatsklinikum Carl Gustav Carus

    Dresden, 01307
    Germany

    Site Not Available

  • Universitaetsklinikum Erlangen

    Erlangen, 91052
    Germany

    Site Not Available

  • Klinikum der Johann Wolfgang Goethe Universitat

    Frankfurt am Main, 60590
    Germany

    Site Not Available

  • Praxis Dr. med S. Rotterdam

    Gelsenkirchen, 45883
    Germany

    Site Not Available

  • Universitaetsklinik Hamburg - Eppendorf

    Hamburg, 20246
    Germany

    Site Not Available

  • Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz

    Mainz, 55131
    Germany

    Site Not Available

  • Universitatsklinikum Muenster

    Munster, 48149
    Germany

    Site Not Available

  • University of Tubingen

    Tübingen, 72076
    Germany

    Site Not Available

  • Universitaetsklinikum Wuerzburg

    Wuerzburg, 97080
    Germany

    Site Not Available

  • Debreceni Egyetem Klinikai Kozpont

    Debrecen, 4032
    Hungary

    Site Not Available

  • Somogy Megyei Kaposi Mor Oktato Korhaz

    Kaposvar, 7400
    Hungary

    Site Not Available

  • Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz

    Miskolc, 3526
    Hungary

    Site Not Available

  • Szegedi Tudomanyegyetem - Szent-Gyorgyi Albert Klinikai Kozpont

    Szeged, 6720
    Hungary

    Site Not Available

  • Veszprem Megyei Csolnoky Ferenc Korhaz-Rendelointezet

    Veszprém, 8200
    Hungary

    Site Not Available

  • Soroka University Medical Center

    Bear-Sheva, 84101
    Israel

    Site Not Available

  • Research Site

    Beer-Sheva, 8410101
    Israel

    Site Not Available

  • Chaim Sheba Medical Center

    Ramat Gan, 5262000
    Israel

    Site Not Available

  • Azienda Ospedaliero Universitaria Di Bologna Policlinico S Orsola Malpighi

    Bologna, 40138
    Italy

    Site Not Available

  • Azienda Ospedaliero Universitaria Di Cagliari

    Caglari, 09124
    Italy

    Site Not Available

  • Azienda Ospedaliera Universitaria di Cagliari

    Cagliari, 09124
    Italy

    Site Not Available

  • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

    Milano, 20122
    Italy

    Site Not Available

  • Azienda Ospedaliera Universitaria Federico II

    Napoli, 80131
    Italy

    Site Not Available

  • Research Site

    Napoli, Campania, 80131
    Italy

    Site Not Available

  • Azienda Ospedaliera di Padova

    Padova, 35128
    Italy

    Site Not Available

  • Azienda Ospedaliera di Reggio Emilia Arcispedale Santa Maria Nuova

    Reggio Emilia, 42123
    Italy

    Site Not Available

  • Istituto Dermatologico San Gallicano IRCCS Dermatologia Clinica

    Roma, 00144
    Italy

    Site Not Available

  • Policlinico Tor Vergata

    Roma, 00133
    Italy

    Site Not Available

  • Istituto Dermatologico San Gallicano IRCCS Dermatologia Clinica

    Rome, 00144
    Italy

    Site Not Available

  • Derma-Norte

    Bosques Del Prado Sur, 20127
    Mexico

    Site Not Available

  • Centro Multidisciplinario para el Desarrollo Especializado de la Investigacion Clinica en Yucatan S

    Merida, 97130
    Mexico

    Site Not Available

  • Hospital Infantil de Mexico Federico Gomez

    Mexico, 06720
    Mexico

    Site Not Available

  • Hospital Universitario "Dr. Jose E. Gonzalez"

    Monterrey, 64460
    Mexico

    Site Not Available

  • Radboud university medical center

    NIjmegen,
    Netherlands

    Site Not Available

  • Altai State Medical University

    Barnaul, 656038
    Russian Federation

    Site Not Available

  • Chelyabinsk Regional Clinical Skin and Venereal Dispensary

    Chelyabinsk, 454092
    Russian Federation

    Site Not Available

  • Ural Scientific Research Institute of Dermatovenereology and Immunopathology

    Ekaterinburg, 620076
    Russian Federation

    Site Not Available

  • Republican Clinical Dermatology and Venerology Dispensary

    Kazan, 420004
    Russian Federation

    Site Not Available

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

    Krasnodar, 350020
    Russian Federation

    Site Not Available

  • Moscow Scientific Practical Center of Dermatology Venerology and Cosmetology

    Moscow, 119071
    Russian Federation

    Site Not Available

  • National Medical Research Center for Children's Health

    Moscow, 119991
    Russian Federation

    Site Not Available

  • Russian Children's Clinical Hospital

    Moscow, 117997
    Russian Federation

    Site Not Available

  • State Scientific Center for Dermatovenereology and Cosmetology

    Moscow, 107076
    Russian Federation

    Site Not Available

  • LLC Medical Center Zdorovaya Semiya

    Novosibirsk, 630099
    Russian Federation

    Site Not Available

  • Skin Disease Clinic if Pier Wolkenstein, LLC

    Saint Peresburg, 191123
    Russian Federation

    Site Not Available

  • LLC PiterKlinika

    Saint Petersburg, 196158
    Russian Federation

    Site Not Available

  • Pierre Wolkenshtein Skin Diseases Clinic LLC

    Saint Petersburg, 191123
    Russian Federation

    Site Not Available

  • Saint Petersburg State Pediatric Medical University

    Saint Petesburg, 194100
    Russian Federation

    Site Not Available

  • Saratov State Medical University

    Saratov, 410028
    Russian Federation

    Site Not Available

  • Bashkiria State Medical University

    Ufa, 450008
    Russian Federation

    Site Not Available

  • Yarosavl State Medical Academy

    Yaroslavl, 150000
    Russian Federation

    Site Not Available

  • Hospital Marques de Valdecilla

    Santander, Cantabria 39008
    Spain

    Site Not Available

  • Hospital General Universitario de Alicante

    Alicante, Comunidad Valenciana 03010
    Spain

    Site Not Available

  • Hospital Universitari Germans Trias i Pujol Can Ruti

    Badalona, 08916
    Spain

    Site Not Available

  • Research Site

    Badalona (Barcelona), 08916
    Spain

    Site Not Available

  • Hospital Sant Joan de Deu

    Barcelona, 08950
    Spain

    Site Not Available

  • Hospital Puerta del Mar

    Cadiz, 11009
    Spain

    Site Not Available

  • Hospital Universitario Reina Sofia

    Cordoba, 14001
    Spain

    Site Not Available

  • Hospital 12 de Octubre

    Madrid, 28041
    Spain

    Site Not Available

  • Hospital General Universitario Gregorio Maranon

    Madrid, 28007
    Spain

    Site Not Available

  • Hospital Infantil Universitario Nino Jesus

    Madrid, 28009
    Spain

    Site Not Available

  • Hospital La Paz

    Madrid, 28046
    Spain

    Site Not Available

  • Complexo Hospitalario De Pontevedra

    Pontevedra, 36001
    Spain

    Site Not Available

  • Hospital Marques de Valdecilla

    Satander, 39008
    Spain

    Site Not Available

  • Hospital Universitario Virgen del Rocio - PPDS

    Sevilla, 41013
    Spain

    Site Not Available

  • University of Alabama Birmingham

    Birmingham, Alabama 35233
    United States

    Site Not Available

  • Phoenix Childrens Hospital

    Phoenix, Arizona 85016
    United States

    Site Not Available

  • Johnson Dermatology Clinic

    Fort Smith, Arkansas 72916
    United States

    Site Not Available

  • Zenith Research Inc.

    Beverly Hills, California 90212
    United States

    Site Not Available

  • First OC Dermatology

    Fountain Valley, California 92708
    United States

    Site Not Available

  • Avance Clinical Trials

    Laguna Niguel, California 92677
    United States

    Site Not Available

  • Stanford University

    Palo Alto, California 94304
    United States

    Site Not Available

  • Coastal Family Dermatology

    San Luis Obispo, California 93401
    United States

    Site Not Available

  • University of California Los Angeles

    Santa Monica, California 90404
    United States

    Site Not Available

  • California Dermatology Institute

    Thousand Oaks, California 91320
    United States

    Site Not Available

  • Solutions Through Advanced Research Inc

    Jacksonville, Florida 32256
    United States

    Site Not Available

  • Glick Skin Institute Clinical Research

    Margate, Florida 33063
    United States

    Site Not Available

  • Ciocca Dermatology

    Miami, Florida 33173
    United States

    Site Not Available

  • University of Miami Hospital

    Miami, Florida 33136
    United States

    Site Not Available

  • University of South Florida Health Morsani Center for Advanced Healthcare

    Tampa, Florida 33612-4742
    United States

    Site Not Available

  • Skin Care Physicians of Georgia

    Macon, Georgia 31217
    United States

    Site Not Available

  • Treasure Valley Medical Research

    Meridian, Idaho 83646
    United States

    Site Not Available

  • DeNova Research

    Chicago, Illinois 60602
    United States

    Site Not Available

  • Dawes Fretzin Dermatology Group Inc

    Indianapolis, Indiana 46256
    United States

    Site Not Available

  • Epiphany Dermatology of Kansas, LLC

    Overland Park, Kansas 66210
    United States

    Site Not Available

  • ActivMed Practices and Research Inc

    Beverly, Massachusetts 01915
    United States

    Site Not Available

  • Mayo Clinic

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • J Woodson Dermatology and Associates Ltd

    Henderson, Nevada 89052
    United States

    Site Not Available

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire 03756
    United States

    Site Not Available

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire 03766
    United States

    Site Not Available

  • Montefiore Medical Center

    Bronx, New York 10467
    United States

    Site Not Available

  • SUNY Downstate Medical Center

    Brooklyn, New York 11203
    United States

    Site Not Available

  • Forest Hills Dermatology Group

    Forest Hills, New York 11375
    United States

    Site Not Available

  • SUNY Downstate Medical Center

    Manhasset, New York 11030
    United States

    Site Not Available

  • Cincinnati Childrens Hospital Medical Center

    Cincinnati, Ohio 45229
    United States

    Site Not Available

  • Wright State Physicians

    Fairborn, Ohio 45324
    United States

    Site Not Available

  • Essential Medical Research, LLC

    Tulsa, Oklahoma 74137
    United States

    Site Not Available

  • Medical University of South Carolina

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • Arlington Research Center

    Arlington, Texas 76011
    United States

    Site Not Available

  • Driscoll Childrens Hospital

    Corpus Christi, Texas 78411
    United States

    Site Not Available

  • Modern Research Associates PLLC

    Dallas, Texas 75231
    United States

    Site Not Available

  • Mosaic Dermatology

    Houston, Texas 77065
    United States

    Site Not Available

  • Texas Dermatology and Laser Specialists

    San Antonio, Texas 78218
    United States

    Site Not Available

  • Jordan Valley Dermatology Center

    West Jordan, Utah 84088
    United States

    Site Not Available

  • MercyHealth East

    Janesville, Wisconsin 53546
    United States

    Site Not Available

  • University of Wisconsin Hospital and Clinics

    Madison, Wisconsin 53715
    United States

    Site Not Available

  • Childrens Hospital of Wisconsin

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

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