Clinical trial NCT04175613: 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
Official title: A Phase 3b, Multi Center, Open-label, Long-term Extension Study of Apremilast (CC-10004) in Pediatric Subjects From 6 Through 17 Years of Age With Moderate to Severe Plaque Psoriasis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Psoriasis
Keywords: Plaque Psoriasis
CC-10004
Apremilast
Pediatric
Age 6 - 17 years
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2019-11-25
Enrollment: 160
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

Subject must satisfy the following criteria to be enrolled in the study:

1. 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.
2. Subject must have a weight of ≥ 20 kg.
3. 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.
4. Subject must have completed Week 52 (Apremilast Extension Phase) of Study CC-10004-PPSO-003.
5. 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.
6. Subject is willing and able to adhere to the study visit schedule and other protocol requirements.
7. 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 ≥ 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.

Exclusion Criteria:

The presence of any of the following will exclude a subject from enrollment:

1. 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.
2. Subject has a condition that confounds the ability to interpret data from the study.
3. Subject has evidence of skin conditions, other than psoriasis, that would interfere with clinical assessments.
4. Subject is pregnant or breastfeeding.
5. Subject has guttate, erythrodermic, or pustular psoriasis.
6. Subject has active tuberculosis (TB) or a history of incompletely treated TB.
7. Subject answers "Yes" to any question on the Columbia-Suicide Severity Rating Scale at Visit 16 of study CC-10004-PPSO-003.
8. Subject plans concurrent use of the following therapies that may have a possible effect on psoriasis.

   1. 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)
   2. 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
9. Subject has prolonged sun exposure or use of tanning booths or other ultraviolet (UV) light sources.
10. 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.

Primary outcomes:
measure: Adverse Events (AEs)
timeFrame: Up to approximately 4 years
measure: Columbia-Suicide Severity Rating Scale (C-SSRS)
timeFrame: Collected at each study visit throughout the life of the study - up to 4 years
measure: Weight of patients treated with Apremilast
timeFrame: Collected at each study visit throughout the life of the study - up to 4 years
measure: Mean body mass index of the patient treated with Apremilast
timeFrame: Collected at each study visit throughout the life of the study - up to 4 years
measure: Height patients treated with Apremilast
timeFrame: Collected at each study visit throughout the life of the study - up to 4 years
measure: Assessment of sexual maturity
timeFrame: Collected every 52 weeks throughout the life of the study - up to 4 years
Secondary outcomes:
measure: Static Physician Global Assessment (sPGA)
timeFrame: Collected at each study visit throughout the life of the study - up to 4 years
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Phoenix Childrens Hospital
state: Arizona
city: Fort Smith
country: United States
facility: Johnson Dermatology Clinic
state: Arkansas
city: Irvine
country: United States
facility: First OC Dermatology
state: California
city: Palo Alto
country: United States
facility: Stanford University School of Medicine
state: California
city: Thousand Oaks
country: United States
facility: California Dermatology Institute
state: California
city: Jacksonville
country: United States
facility: Solutions Through Advanced Research Inc
state: Florida
city: Miami
country: United States
facility: Ciocca Dermatology
state: Florida
city: Macon
country: United States
facility: Skin Care Physicians of Georgia
state: Georgia
city: Indianapolis
country: United States
facility: Dawes Fretzin Dermatology Group Inc
state: Indiana
city: Fairborn
country: United States
facility: Wright State Physicians
state: Ohio
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: San Antonio
country: United States
facility: Driscoll Childrens Hospital
state: Texas
city: Madison
country: United States
facility: University of Wisconsin Hospital and Clinics
state: Wisconsin
city: Brussels
country: Belgium
facility: Centre Hospitalier Universitaire Saint Pierre
city: Brussels
country: Belgium
facility: Cliniques Universitaires Saint Luc
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent
city: Edmonton
country: Canada
facility: Stollery Childrens Hospital
state: Alberta
city: Winnipeg
country: Canada
facility: Winnipeg Clinic Dermatology Research
state: Manitoba
city: St. John's
country: Canada
facility: Karma Clinical Trials
state: Newfoundland and Labrador
city: Toronto
country: Canada
facility: AvantDerm
state: Ontario
city: Praha 10
country: Czechia
facility: Fakultni nemocnice Kralovske Vinohrady
city: Praha
country: Czechia
facility: Synexus Czech sro
city: Martigues
country: France
facility: Cabinet du Docteur Ruer-Mulard Mireille
city: Toulouse
country: France
facility: Centre Hospitalier Universitaire de Toulouse - Hopital Larrey
city: Bear Sheva
country: Israel
facility: Soroka University Medical Center
city: Cagliari
country: Italy
facility: Azienda Ospedaliero Universitaria Di Cagliari
city: Milano
country: Italy
facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
city: Padova
country: Italy
facility: Azienda Ospedaliera di Padova
city: Barnaul
country: Russian Federation
facility: Altai State Medical University
city: Chelyabinsk
country: Russian Federation
facility: Chelyabinsk Regional Clinical Skin and Venereal Dispensary
city: Ekaterinburg
country: Russian Federation
facility: Ural Scientific Research Institute of Dermatovenereology and Immunopathology
city: Kazan
country: Russian Federation
facility: Republican Clinical Dermatology and Venerology Dispensary
city: Krasnodar
country: Russian Federation
facility: Clinical Dispensary of Dermatology and Venereology of Krasnodar Territory of the Ministry of Health
city: Moscow
country: Russian Federation
facility: State Scientific Center for Dermatovenereology and Cosmetology
city: Moscow
country: Russian Federation
facility: Moscow Scientific Practical Center of Dermatology Venerology and Cosmetology
city: Moscow
country: Russian Federation
facility: National Medical Research Center for Children Health
city: Novosibirsk
country: Russian Federation
facility: LLC Medical Center Zdorovaya Semiya
city: Saint Petersburg
country: Russian Federation
facility: Pierre Wolkenshtein Skin Diseases Clinic LLC
city: Saint Petersburg
country: Russian Federation
facility: Saint Petersburg State Pediatric Medical University
city: Saint Petersburg
country: Russian Federation
facility: LLC PiterKlinika
city: Ufa
country: Russian Federation
facility: Bashkiria State Medical University
city: Yaroslavl
country: Russian Federation
facility: Yarosavl State Medical Academy
city: Esplugues de Llobregat
country: Spain
facility: Hospital Sant Joan de Deu
state: Cataluña
city: Alicante
country: Spain
facility: General University Hospital of Alicante
city: Badalona
country: Spain
facility: Hopsital Germans Trias I Pujol
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Maranon
city: Madrid
country: Spain
facility: Hospital Infantil Universitario Nino Jesus
city: Madrid
country: Spain
facility: Hospital 12 de Octubre
city: Madrid
country: Spain
facility: Hospital La Paz
city: Santander
country: Spain
facility: Hospital Marques de Valdecilla
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: