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

  • STATUS
    Recruiting
  • End date
    Mar 6, 2027
  • participants needed
    140
  • sponsor
    Amgen
Updated on 14 October 2022
cervical cap
tubal ligation
hormonal contraception
option 2
cc-10004
apremilast
plaque psoriasis

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.

Details
Condition Psoriasis
Treatment Apremilast
Clinical Study IdentifierNCT04175613
SponsorAmgen
Last Modified on14 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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 ≥ 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 ≥ 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

Subject has a condition, including the presence of laboratory abnormalities, or
The presence of any of the following will exclude a subject from enrollment
psychiatric illness, that would place the subject at unacceptable risk if he/she were
Subject has a condition that confounds the ability to interpret data from the study
to participate in the study
Subject is pregnant or breastfeeding
Subject has evidence of skin conditions, other than psoriasis, that would interfere
Subject has guttate, erythrodermic, or pustular psoriasis
with clinical assessments
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
Biologic therapy
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)
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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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