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

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Updated on 14 October 2022

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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 Identifier	NCT04175613
Sponsor	Amgen
Last Modified on	14 October 2022

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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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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

Amgen Call Center

Karma Clinical Trials (3.5 mi away) Contact