Impact of apremilast in patients with specific manifestations of plaquepsoriasis and a significantly impaired quality of life.
- Conditions
- Plaque PsoriasisMedDRA version: 20.0Level: LLTClassification code 10071117Term: Plaque psoriasisSystem Organ Class: 100000004858Therapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2018-002850-58-IT
- Lead Sponsor
- CELGENE INTERNATIONAL II SàR
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 255
1. Subject is = 18 years of age at the time of signing the informed
consent form (ICF).
2. Subject must understand and voluntarily sign an ICF prior to any
study-related assessments/procedures being conducted.
3. Subject is willing and able to adhere to the study visit schedule and
other protocol requirements.
4. Subject has diagnosis of chronic plaque psoriasis for at least 6 months
prior to baseline.
5. Subject has a PASI score ranging from =3 to = 10 at baseline.
6. Subject has a DLQI score > 10 at baseline.
7. Subject has presence of = 1 clinical manifestations of plaque
psoriasis, defined as at least one of the following:
a. Moderate to severe scalp psoriasis, defined as Scalp Physician Global
Assessment (ScPGA) = 3
b. Nail psoriasis, defined as onycholysis and onychodystrophy in at least
2 fingernails
c. Moderate to severe genital plaque psoriasis, defined as modified static
Physicians Global Assessment of Genitalia (sPGA-G) = 3
d. Moderate to severe palmoplantar psoriasis, defined as Palmoplantar
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Psoriasis Physicians Global Assessment (PPPGA) = 3
e. Moderate to severe plaque psoriasis in visible locations (dorsal hand,
face, neck, and hairline) with static Physicians Global Assessment
(sPGA) = 3
8. Subject must be in general good health (except for psoriasis) as
judged by the Investigator, based on medical history, physical
examination, and clinical laboratories.
(NOTE: The definition of good health means a subject does not have
uncontrolled significant co-morbid conditions.)
9. Subject must have failed to respond to, be contraindicated to, or
intolerant to other conventional systemic therapy (including, but not
limited to, cyclosporine, methotrexate, acitretin, OR fumaric acid esters)
or biologic therapies.
10. Subjects (in Italy only) must be non-responder to, contraindicated
to, or intolerant to other systemic therapy (including cyclosporine,
methotrexate, or PUVA) AND also be contraindicated to, or intolerant to
biologics.
11. Females of childbearing potential (FCBP)† must have a negative
pregnancy test at Screening and Baseline. While on investigational
product and for at least 28 days after taking the last dose of
investigational product, 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 highly 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 (latex 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.
A female of childbearing potential is defined as a sexually mature female
who 1) has not undergone a hysterectomy (the surgical removal of the
uterus) or bilateral oophorectomy (the surgical removal of both ovaries)
or 2) has not been postmenopausal for at least 24 consecutive months
(that is, has had menses at any time during the preceding 24
consecutive months).
§ The female subject's chosen form of contraception must be effective by
the time the female subject is randomized into the study (for example,
hormonal contraception should be initiated at least 28 days before
randomization).
Are the trial subjects und
1. Subject has any significant medical condition, laboratory abnormality,
or psychiatric illness that would prevent the subject from participating in
the study.
2. Subject has any condition, including other inflammatory diseases or
dermatologic conditions, which confounds the ability to interpret data
from the study, including other types of psoriasis (ie, erythrodermic, or
guttate), other than plaque psoriasis, inverse psoriasis.
3. Subject has history of drug-induced psoriasis.
4. Subject has arthritis that requires systemic treatment.
5. Subject unable to avoid use of tanning booths for at least 4 weeks
prior to baseline and during study.
6. Subject is currently enrolled in any other clinical trial involving an
investigational product.
7. Other than psoriasis, subject has any clinically significant (asdetermined by the Investigator) cardiac, endocrinologic, pulmonary,
neurologic, psychiatric, hepatic, renal, hematologic, immunologic
disease, or other major disease that is currently uncontrolled.
8. Malignancy or history of malignancy or myeloproliferative or
lymphoproliferative disease within the past 3 years, except for treated
(ie, cured) basal cell or squamous cell
in situ skin carcinomas.
9. Bacterial infections requiring treatment with oral or injectable
antibiotics, or significant viral or fungal infections, within 4 weeks of
Screening. Any treatment for such infections must have been completed
and the infection cured, at least 4 weeks prior to Screening and no new
or recurrent infections prior to the Baseline Visit.
10. Subject has received a live vaccine within 3 months of baseline or
plans to do so during study.
11. Subject is a pregnant or breastfeeding (lactating) woman.
12. Subject has used topical therapy within 2 weeks of randomization
(including, but not limited to, topical corticosteroids, retinoids or vitamin
D analog preparations, tacrolimus, pimecrolimus, anthralin/dithranol, or
moisturizers which contain urea or salicylic acid). Use of phototherapy
within 4 weeks prior to randomization. Use of conventional systemic
therapy or systemic corticosteroids within 4 weeks prior to
randomization, except for conditions other than psoriasis or psoriatic
arthritis. Use of biologic therapy within 5 pharmacokinetic half-lives.
13. Prior treatment with apremilast, or participation in a clinical study,
involving apremilast.
14. Subject has any condition including the presence of laboratory
abnormalities, which places the subject at unacceptable risk if he/she
were to participate in the study.
15. Subject has any condition that confounds the ability to interpret data
from the study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of the study is to assess the impact of apremilast,<br>compared to placebo, on health related quality of life (qol) in subjects<br>with manifestations of plaque psoriasis and impaired quality of life at<br>Week 16.;Secondary Objective: - To assess the efficacy and safety of apremilast compared to placebo in<br>subjects with manifestations of plaque psoriasis and impaired quality of<br>life at Week 16<br>- To assess the long-term effects of apremilast with respect to quality of<br>life, efficacy, and safety at Weeks 32 and 52;Primary end point(s): Dermatology Life Quality Index (DLQI) - Proportion of subjects who<br>achieve a = 4-point reduction from baseline;Timepoint(s) of evaluation of this end point: Week 16
- Secondary Outcome Measures
Name Time Method