Psoriasis Clinical Trial

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

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.

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Full 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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Males or female subjects 6 to 17 years of age, inclusive, at the time the informed consent 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 for psoriasis
Candidate for systemic therapy or phototherapy

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 to Screening or randomization in the study, or major psychiatric illness requiring hospitalization within 3 years prior to signing the assent and informed consent
Answer "Yes" to any question on the Columbia-Suicide Severity Rating Scale during Screening or at Baseline

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).

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

245

Study ID:

NCT03701763

Recruitment Status:

Terminated

Sponsor:

Amgen

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There are 98 Locations for this study

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University of Alabama Birmingham
Birmingham Alabama, 35233, United States
Phoenix Childrens Hospital
Phoenix Arizona, 85016, United States
Johnson Dermatology Clinic
Fort Smith Arkansas, 72916, United States
Zenith Research Inc.
Beverly Hills California, 90212, United States
First OC Dermatology
Fountain Valley California, 92708, United States
Avance Clinical Trials
Laguna Niguel California, 92677, United States
Stanford University
Palo Alto California, 94304, United States
Coastal Family Dermatology
San Luis Obispo California, 93401, United States
University of California Los Angeles
Santa Monica California, 90404, United States
California Dermatology Institute
Thousand Oaks California, 91320, United States
Solutions Through Advanced Research Inc
Jacksonville Florida, 32256, United States
Glick Skin Institute Clinical Research
Margate Florida, 33063, United States
University of Miami Hospital
Miami Florida, 33136, United States
Ciocca Dermatology
Miami Florida, 33173, United States
University of South Florida Health Morsani Center for Advanced Healthcare
Tampa Florida, 33612, United States
Skin Care Physicians of Georgia
Macon Georgia, 31217, United States
Treasure Valley Medical Research
Meridian Idaho, 83646, United States
DeNova Research
Chicago Illinois, 60602, United States
Dawes Fretzin Dermatology Group Inc
Indianapolis Indiana, 46256, United States
Epiphany Dermatology of Kansas, LLC
Overland Park Kansas, 66210, United States
ActivMed Practices and Research Inc
Beverly Massachusetts, 01915, United States
Mayo Clinic
Rochester Minnesota, 55905, United States
J Woodson Dermatology and Associates Ltd
Henderson Nevada, 89052, United States
Dartmouth-Hitchcock Medical Center
Lebanon New Hampshire, 03766, United States
Montefiore Medical Center
Bronx New York, 10467, United States
Forest Hills Dermatology Group
Forest Hills New York, 11375, United States
SUNY Downstate Medical Center
Manhasset New York, 11030, United States
Cincinnati Childrens Hospital Medical Center
Cincinnati Ohio, 45229, United States
Wright State Physicians
Fairborn Ohio, 45324, United States
Essential Medical Research, LLC
Tulsa Oklahoma, 74137, United States
Medical University of South Carolina
Charleston South Carolina, 29425, United States
Arlington Research Center
Arlington Texas, 76011, United States
Driscoll Childrens Hospital
Corpus Christi Texas, 78411, United States
Modern Research Associates PLLC
Dallas Texas, 75231, United States
Mosaic Dermatology
Houston Texas, 77065, United States
Texas Dermatology and Laser Specialists
San Antonio Texas, 78218, United States
Jordan Valley Dermatology Center
West Jordan Utah, 84088, United States
University of Wisconsin Hospital and Clinics
Madison Wisconsin, 53715, United States
Childrens Hospital of Wisconsin
Milwaukee Wisconsin, 53226, United States
Centre Hospitalier Universitaire Saint Pierre
Brussels , 1000, Belgium
Cliniques Universitaires St Luc
Bruxelles , 1200, Belgium
Universitair Ziekenhuis Gent
Gent , 9000, Belgium
Kirk Barber Research
Calgary Alberta, T2G 1, Canada
Stollery Children's Hospital
Edmonton Alberta, T6G 2, Canada
Enverus Medical Research
Surrey British Columbia, V3R 6, Canada
Winnipeg Clinic Dermatology Research
Winnipeg Manitoba, R3C 0, Canada
Karma Clinical Trials
Saint John's Newfoundland and Labrador, A1A 4, Canada
AvantDerm
Toronto Ontario, M5A 3, Canada
CHU Saint-Justine
Montreal Quebec, H3T 1, Canada
Fakultni nemocnice Hradec Kralove
Hradec Kralove , 500 0, Czechia
Fakultni nemocnice Kralovske Vinohrady
Praha 1 , 110 0, Czechia
Synexus Czech sro
Praha , 120 0, Czechia
Centre Hospitalier Victor Dupouy Argenteuil
Argenteuil , 95107, France
Centre Hospitalier Universitaire Lyon
Bron cedex , 69677, France
Cabinet du Docteur Ruer-Mulard Mireille
Martigues , 13500, France
Hotel Dieu CHU Nantes
Nantes , 44093, France
Centre Hospitalier Universitaire de Nice
Nice , 06202, France
Hopital Necker
Paris Cedex 15 , 75015, France
Centre Hospitalier de Cornouaille - Hopital Laennec
Quimper , 29018, France
CHU Saint Etienne Hopital Nord
Saint-Priest En Jarrez , 42055, France
Centre Hospitalier Universitaire de Toulouse - Hopital Larrey
Toulouse Cedex 9 , 31059, France
Centre Hospitalier de Valence
Valence , 26000, France
Chaim Sheba Medical Center
Ramat Gan , 52620, Israel
Azienda Ospedaliero Universitaria Di Bologna Policlinico S Orsola Malpighi
Bologna , 40138, Italy
Azienda Ospedaliera Universitaria di Cagliari
Cagliari , 09124, Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Milano , 20122, Italy
Azienda Ospedaliera Universitaria Federico II
Napoli , 80131, Italy
Azienda Ospedaliera di Padova
Padova , 35128, Italy
Azienda Ospedaliera di Reggio Emilia Arcispedale Santa Maria Nuova
Reggio Emilia , 42123, Italy
Policlinico Tor Vergata
Roma , 00133, Italy
Istituto Dermatologico San Gallicano IRCCS Dermatologia Clinica
Roma , 00144, Italy
Radboud university medical center
NIjmegen , , Netherlands
Altai State Medical University
Barnaul , 65603, Russian Federation
Chelyabinsk Regional Clinical Skin and Venereal Dispensary
Chelyabinsk , 45409, Russian Federation
Ural Scientific Research Institute of Dermatovenereology and Immunopathology
Ekaterinburg , 62007, Russian Federation
Republican Clinical Dermatology and Venerology Dispensary
Kazan , 42000, 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
Russian Children's Clinical Hospital
Moscow , 11799, 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
LLC PiterKlinika
Saint Petersburg , 19615, Russian Federation
Saint Petersburg State Pediatric Medical University
Saint Petesburg , 19410, Russian Federation
Bashkiria State Medical University
Ufa , 45000, Russian Federation
Yarosavl State Medical Academy
Yaroslavl , 15000, Russian Federation
Hospital Marques de Valdecilla
Santander Cantabria, 39008, Spain
Hospital General Universitario de Alicante
Alicante Comunidad Valenciana, 03010, Spain
Hospital Universitari Germans Trias i Pujol Can Ruti
Badalona , 08916, Spain
Hospital Sant Joan de Deu
Barcelona , 08950, Spain
Hospital Puerta del Mar
Cadiz , 11009, Spain
Hospital Universitario Reina Sofia
Cordoba , 14001, 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
Complexo Hospitalario De Pontevedra
Pontevedra , 36001, Spain
Hospital Universitario Virgen del Rocio - PPDS
Sevilla , 41013, Spain

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

245

Study ID:

NCT03701763

Recruitment Status:

Terminated

Sponsor:


Amgen

How clear is this clinincal trial information?

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