A Long-term Extension Study of Apremilast (CC-10004) in Pediatric Subjects From 6 Through 17 Years of Age With Moderate to Severe Plaque Psoriasis
- Registration Number
- NCT04175613
- Lead Sponsor
- Amgen
- Brief Summary
This study was created to provide subjects who complete Week 52 (end of Apremilast Extension Phase) of study CC-10004-PPSO-003 the option to continue to receive open-label apremilast therapy.
The study will consist of up to 208 weeks of long-term treatment followed by an 8-week observational follow-up phase.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 160
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 informed consent document is signed by the legal guardian.
- Subject must have a weight of โฅ 20 kg.
- Subjects must have an age and sex specific BMI value no lower in range than the 5th percentile on the Centers for Disease Control (CDC) growth chart for children and adolescents.
- Subject must have completed Week 52 (Apremilast Extension Phase) of Study CC-10004-PPSO-003.
- Subject is able to sign an assent with a legal guardian/s who understand/s and voluntarily sign/s an informed consent prior to any study-related assessments/procedures being conducted.
- Subject is willing and able to adhere to the study visit schedule and other protocol requirements.
- All female subjects of childbearing potential (FCBP) must either practice abstinence from heterosexual contact or use one of the approved contraceptive options as described below while on apremilast and for at least 28 days after administration of the last dose of apremilast. For the purpose of this study, a female subject is considered of childbearing potential if she is โฅ 12 years old or has reached menarche, 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.
The presence of any of the following will exclude a subject from enrollment:
-
Subject has a condition, including the presence of laboratory abnormalities, or psychiatric illness, that would place the subject at unacceptable risk if he/she were 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 interfere with 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 Scale at Visit 16 of study CC-10004-PPSO-003.
-
Subject plans concurrent use of the following therapies that may have a possible effect on psoriasis.
- Conventional systemic therapy for psoriasis (including but not limited to cyclosporine, corticosteroids, methotrexate, oral retinoids, mycophenolate, thioguanine, hydroxyurea, sirolimus, sulfasalazine, azathioprine, and fumaric acid esters)
- Biologic therapy:
i. Etanercept (or biosimilar) treatment ii. Adalimumab (or biosimilar) treatment iii. Other TNF or interleukin (IL)-17 blockers (such as infliximab, certolizumab pegol, secukinumab, ixekizumab, brodalumab, or their biosimilars) iv. Anti-IL-12 or anti-IL-23 treatment (such as ustekinumab, guselkumab, or tildrakizumab) c) Use of any 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 an agency, organization, institution or entity by the courts, the government or a government body, acting in accordance with powers conferred on them by law or regulation.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Patients treated with Apremilast Apremilast Subjects with a weight between 20 kg to \< 50 kg will receive apremilast 20 mg BID and subjects with weight โฅ 50 kg at Visit 1 will receive apremilast 30 mg BID. Subjects that begin the study receiving apremilast 20 mg BID and later record a body weight โฅ 50 kg, will be switched to apremilast 30 mg BID.
- Primary Outcome Measures
Name Time Method Adverse Events (AEs) Up to approximately 4 years An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the subject's health, including laboratory test values, regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) should be considered an AE.
Columbia-Suicide Severity Rating Scale (C-SSRS) Collected at each study visit throughout the life of the study - up to 4 years Questionnaire to monitor depression, suicidal thoughts and behavior
Weight of patients treated with Apremilast Collected at each study visit throughout the life of the study - up to 4 years Body weight in kg
Height patients treated with Apremilast Collected at each study visit throughout the life of the study - up to 4 years Height (inches or centimeters) will be collected for all pediatric subjects and descriptively summarized
Mean body mass index of the patient treated with Apremilast Collected at each study visit throughout the life of the study - up to 4 years BMI (combined outcome of weight and height in the form of kg/m\^2)
Assessment of sexual maturity Collected every 52 weeks throughout the life of the study - up to 4 years Sexual maturation, assessed by Tanner staging system, will be conducted for all pediatric subjects and descriptively summarized
- Secondary Outcome Measures
Name Time Method Static Physician Global Assessment (sPGA) Collected at each study visit throughout the life of the study - up to 4 years is the assessment by the Investigator of the overall disease severity at the time of evaluation. The sPGA is a 5-point scale ranging from 0 (clear) to 4 (severe), incorporating an assessment of the severity of the three primary signs of the disease: erythema, scaling and plaque elevation.
Trial Locations
- Locations (50)
First OC Dermatology
๐บ๐ธIrvine, California, United States
AvantDerm
๐จ๐ฆToronto, Ontario, Canada
Hopsital Germans Trias I Pujol
๐ช๐ธBadalona, Spain
Azienda Ospedaliera di Padova
๐ฎ๐นPadova, Italy
Fakultni nemocnice Kralovske Vinohrady
๐จ๐ฟPraha 10, Czechia
University of Wisconsin Hospital and Clinics
๐บ๐ธMadison, Wisconsin, United States
Hospital La Paz
๐ช๐ธMadrid, Spain
Hospital Marques de Valdecilla
๐ช๐ธSantander, Spain
Stanford University School of Medicine
๐บ๐ธPalo Alto, California, United States
Skin Care Physicians of Georgia
๐บ๐ธMacon, Georgia, United States
Wright State Physicians
๐บ๐ธFairborn, Ohio, United States
Solutions Through Advanced Research Inc
๐บ๐ธJacksonville, Florida, United States
California Dermatology Institute
๐บ๐ธThousand Oaks, California, United States
Centre Hospitalier Universitaire Saint Pierre
๐ง๐ชBrussels, Belgium
Cliniques Universitaires Saint Luc
๐ง๐ชBrussels, Belgium
Universitair Ziekenhuis Gent
๐ง๐ชGent, Belgium
Stollery Childrens Hospital
๐จ๐ฆEdmonton, Alberta, Canada
Karma Clinical Trials
๐จ๐ฆSt. John's, Newfoundland and Labrador, Canada
Winnipeg Clinic Dermatology Research
๐จ๐ฆWinnipeg, Manitoba, Canada
Centre Hospitalier Universitaire de Toulouse - Hopital Larrey
๐ซ๐ทToulouse, France
Cabinet du Docteur Ruer-Mulard Mireille
๐ซ๐ทMartigues, France
Synexus Czech sro
๐จ๐ฟPraha, Czechia
Soroka University Medical Center
๐ฎ๐ฑBear Sheva, Israel
Azienda Ospedaliero Universitaria Di Cagliari
๐ฎ๐นCagliari, Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
๐ฎ๐นMilano, Italy
Altai State Medical University
๐ท๐บBarnaul, Russian Federation
Ural Scientific Research Institute of Dermatovenereology and Immunopathology
๐ท๐บEkaterinburg, Russian Federation
Chelyabinsk Regional Clinical Skin and Venereal Dispensary
๐ท๐บChelyabinsk, Russian Federation
Moscow Scientific Practical Center of Dermatology Venerology and Cosmetology
๐ท๐บMoscow, Russian Federation
National Medical Research Center for Children Health
๐ท๐บMoscow, Russian Federation
LLC Medical Center Zdorovaya Semiya
๐ท๐บNovosibirsk, Russian Federation
Pierre Wolkenshtein Skin Diseases Clinic LLC
๐ท๐บSaint Petersburg, Russian Federation
Saint Petersburg State Pediatric Medical University
๐ท๐บSaint Petersburg, Russian Federation
Bashkiria State Medical University
๐ท๐บUfa, Russian Federation
Yarosavl State Medical Academy
๐ท๐บYaroslavl, Russian Federation
Hospital Sant Joan de Deu
๐ช๐ธEsplugues de Llobregat, Cataluรฑa, Spain
Hospital General Universitario Gregorio Maranon
๐ช๐ธMadrid, Spain
LLC PiterKlinika
๐ท๐บSaint Petersburg, Russian Federation
General University Hospital of Alicante
๐ช๐ธAlicante, Spain
Hospital 12 de Octubre
๐ช๐ธMadrid, Spain
Hospital Infantil Universitario Nino Jesus
๐ช๐ธMadrid, Spain
Phoenix Childrens Hospital
๐บ๐ธPhoenix, Arizona, United States
Ciocca Dermatology
๐บ๐ธMiami, Florida, United States
Dawes Fretzin Dermatology Group Inc
๐บ๐ธIndianapolis, Indiana, United States
Medical University of South Carolina
๐บ๐ธCharleston, South Carolina, United States
Driscoll Childrens Hospital
๐บ๐ธSan Antonio, Texas, United States
Republican Clinical Dermatology and Venerology Dispensary
๐ท๐บKazan, Russian Federation
Johnson Dermatology Clinic
๐บ๐ธFort Smith, Arkansas, United States
Clinical Dispensary of Dermatology and Venereology of Krasnodar Territory of the Ministry of Health
๐ท๐บKrasnodar, Russian Federation
State Scientific Center for Dermatovenereology and Cosmetology
๐ท๐บMoscow, Russian Federation