Efficacy and Safety Study of Apremilast (CC-10004) in Pediatric Subjects From 6 Through 17 Years of Age With Moderate to Severe Plaque Psoriasis
NCT ID: NCT03701763
Last Updated: 2024-12-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
245 participants
INTERVENTIONAL
2018-12-19
2023-03-27
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Administration of Apremilast (CC-10004) - 20mg
Apremilast 20mg Twice Daily (BID)
Apremilast (CC-10004)
Apremilast (CC-10004)
Administration of Apremilast (CC-10004) - 30mg
Apremilast 30mg Twice Daily (BID)
Apremilast (CC-10004)
Apremilast (CC-10004)
Administration of Placebo
Placebo tablet Twice Daily (BID)
Placebo
Placebo
Interventions
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Apremilast (CC-10004)
Apremilast (CC-10004)
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
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)
5. Disease inadequately controlled by or inappropriate for topical therapy for psoriasis
6. Candidate for systemic therapy or phototherapy
Exclusion Criteria
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 to Screening or randomization in the study, or major psychiatric illness requiring hospitalization within 3 years prior to signing the assent and informed consent
4. Answer "Yes" to any question on the Columbia-Suicide Severity Rating Scale during Screening or at Baseline
5. Current or planned concurrent use of the following therapies that may have a possible effect on psoriasis
a. Topical therapy within 2 weeks prior to randomization (including but not limited to 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 groin in 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 the clinic visit.
b. Conventional systemic therapy for psoriasis within 4 weeks prior to randomization c. Phototherapy treatment (ie, ultraviolet B \[UVB\], PUVA) within 4 weeks prior to randomization d. Biologic therapy within 4 weeks prior to randomization or 5 PK/PD half-lives (whichever is longer).
6 Years
17 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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University of Alabama Birmingham
Birmingham, Alabama, United States
Phoenix Childrens Hospital
Phoenix, Arizona, United States
Johnson Dermatology Clinic
Fort Smith, Arkansas, United States
Zenith Research Inc.
Beverly Hills, California, United States
First OC Dermatology
Fountain Valley, California, United States
Avance Clinical Trials
Laguna Niguel, California, United States
Stanford University
Palo Alto, California, United States
Coastal Family Dermatology
San Luis Obispo, California, United States
University of California Los Angeles
Santa Monica, California, United States
California Dermatology Institute
Thousand Oaks, California, United States
Solutions Through Advanced Research Inc
Jacksonville, Florida, United States
Glick Skin Institute Clinical Research
Margate, Florida, United States
University of Miami Hospital
Miami, Florida, United States
Ciocca Dermatology
Miami, Florida, United States
University of South Florida Health Morsani Center for Advanced Healthcare
Tampa, Florida, United States
Skin Care Physicians of Georgia
Macon, Georgia, United States
Treasure Valley Medical Research
Meridian, Idaho, United States
DeNova Research
Chicago, Illinois, United States
Dawes Fretzin Dermatology Group Inc
Indianapolis, Indiana, United States
Epiphany Dermatology of Kansas, LLC
Overland Park, Kansas, United States
ActivMed Practices and Research Inc
Beverly, Massachusetts, United States
Mayo Clinic
Rochester, Minnesota, United States
J Woodson Dermatology and Associates Ltd
Henderson, Nevada, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Forest Hills Dermatology Group
Forest Hills, New York, United States
SUNY Downstate Medical Center
Manhasset, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Cincinnati Childrens Hospital Medical Center
Cincinnati, Ohio, United States
Wright State Physicians
Fairborn, Ohio, United States
Essential Medical Research, LLC
Tulsa, Oklahoma, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Arlington Research Center
Arlington, Texas, United States
Driscoll Childrens Hospital
Corpus Christi, Texas, United States
Modern Research Associates PLLC
Dallas, Texas, United States
Mosaic Dermatology
Houston, Texas, United States
Texas Dermatology and Laser Specialists
San Antonio, Texas, United States
Jordan Valley Dermatology Center
West Jordan, Utah, United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States
Childrens Hospital of Wisconsin
Milwaukee, Wisconsin, United States
Centre Hospitalier Universitaire Saint Pierre
Brussels, , Belgium
Cliniques Universitaires St Luc
Brussels, , Belgium
Universitair Ziekenhuis Gent
Ghent, , Belgium
Kirk Barber Research
Calgary, Alberta, Canada
Stollery Children's Hospital
Edmonton, Alberta, Canada
Enverus Medical Research
Surrey, British Columbia, Canada
Winnipeg Clinic Dermatology Research
Winnipeg, Manitoba, Canada
Karma Clinical Trials
St. John's, Newfoundland and Labrador, Canada
AvantDerm
Toronto, Ontario, Canada
CHU Saint-Justine
Montreal, Quebec, Canada
Fakultni nemocnice Hradec Kralove
Hradec Králové, , Czechia
Fakultni nemocnice Kralovske Vinohrady
Prague, , Czechia
Synexus Czech sro
Prague, , Czechia
Centre Hospitalier Victor Dupouy Argenteuil
Argenteuil, , France
Centre Hospitalier Universitaire Lyon
Bron, , France
Cabinet du Docteur Ruer-Mulard Mireille
Martigues, , France
Hotel Dieu CHU Nantes
Nantes, , France
Centre Hospitalier Universitaire de Nice
Nice, , France
Hopital Necker
Paris, , France
Centre Hospitalier de Cornouaille - Hopital Laennec
Quimper, , France
CHU Saint Etienne Hopital Nord
Saint-Priest En Jarrez, , France
Centre Hospitalier Universitaire de Toulouse - Hopital Larrey
Toulouse, , France
Centre Hospitalier de Valence
Valence, , France
Chaim Sheba Medical Center
Ramat Gan, , Israel
Azienda Ospedaliero Universitaria Di Bologna Policlinico S Orsola Malpighi
Bologna, , Italy
Azienda Ospedaliera Universitaria di Cagliari
Cagliari, , Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Milan, , Italy
Azienda Ospedaliera Universitaria Federico II
Napoli, , Italy
Azienda Ospedaliera di Padova
Padua, , Italy
Azienda Ospedaliera di Reggio Emilia Arcispedale Santa Maria Nuova
Reggio Emilia, , Italy
Policlinico Tor Vergata
Roma, , Italy
Istituto Dermatologico San Gallicano IRCCS Dermatologia Clinica
Roma, , Italy
Radboud university medical center
Nijmegen, , Netherlands
Altai State Medical University
Barnaul, , Russia
Chelyabinsk Regional Clinical Skin and Venereal Dispensary
Chelyabinsk, , Russia
Republican Clinical Dermatology and Venerology Dispensary
Kazan', , Russia
Clinical Dispensary of Dermatology and Venereology of Krasnodar Territory of the Ministry of Health
Krasnodar, , Russia
State Scientific Center for Dermatovenereology and Cosmetology
Moscow, , Russia
Russian Children's Clinical Hospital
Moscow, , Russia
Moscow Scientific Practical Center of Dermatology Venerology and Cosmetology
Moscow, , Russia
National Medical Research Center for Children's Health
Moscow, , Russia
LLC Medical Center Zdorovaya Semiya
Novosibirsk, , Russia
Pierre Wolkenshtein Skin Diseases Clinic LLC
Saint Petersburg, , Russia
LLC PiterKlinika
Saint Petersburg, , Russia
Saint Petersburg State Pediatric Medical University
Saint Petesburg, , Russia
Bashkiria State Medical University
Ufa, , Russia
Yarosavl State Medical Academy
Yaroslavl, , Russia
Ural Scientific Research Institute of Dermatovenereology and Immunopathology
Yekaterinburg, , Russia
Hospital Marques de Valdecilla
Santander, Cantabria, Spain
Hospital General Universitario de Alicante
Alicante, Valencia, Spain
Hospital Universitari Germans Trias i Pujol Can Ruti
Badalona, , Spain
Hospital Sant Joan de Deu
Barcelona, , Spain
Hospital Puerta del Mar
Cadiz, , Spain
Hospital Universitario Reina Sofia
Córdoba, , Spain
Hospital General Universitario Gregorio Maranon
Madrid, , Spain
Hospital Infantil Universitario Nino Jesus
Madrid, , Spain
Hospital 12 de Octubre
Madrid, , Spain
Hospital La Paz
Madrid, , Spain
Complexo Hospitalario De Pontevedra
Pontevedra, , Spain
Hospital Universitario Virgen del Rocio - PPDS
Seville, , Spain
Countries
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References
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Fiorillo L, Becker E, de Lucas R, Belloni-Fortina A, Armesto S, Elewski B, Maes P, Oberoi RK, Paris M, Zhang W, Zhang Z, Arkin L. Efficacy and safety of apremilast in pediatric patients with moderate-to-severe plaque psoriasis: 16-week results from SPROUT, a randomized controlled trial. J Am Acad Dermatol. 2024 Jun;90(6):1232-1239. doi: 10.1016/j.jaad.2023.11.068. Epub 2024 Jan 23.
Paller AS, Fiorillo L, Becker E, Armesto S, Kontzias A, Oberoi RK, Zhang W, Amouzadeh H, Zhang Z, Arkin L. Efficacy and safety of apremilast in pediatric patients with moderate to severe plaque psoriasis: 52-week results from the SPROUT randomized controlled trial. Br J Dermatol. 2025 Jul 30:ljaf305. doi: 10.1093/bjd/ljaf305. Online ahead of print.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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AmgenTrials clinical trials website
Other Identifiers
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U1111-1219-3112
Identifier Type: REGISTRY
Identifier Source: secondary_id
2018-002918-12
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CC-10004-PPSO-003
Identifier Type: -
Identifier Source: org_study_id