Karma Clinical Trials | St. Johns, NL
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About
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Subject must satisfy the following criteria to be enrolled in the study:
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:
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.
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.
Primary purpose
Allocation
Interventional model
Masking
160 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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