EUCTR2018-002850-58-IT进行中（未招募）1 期
A PHASE 4, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLEDSTUDY OF THE IMPACT OF APREMILAST (CC-10004) ONQUALITY OF LIFE, EFFICACY, AND SAFETY IN SUBJECTS WITHMANIFESTATIONS OF PLAQUE PSORIASIS AND IMPAIRED QUALITY OFLIFE - EMBRACE
CELGENE INTERNATIONAL II SàR0 个研究点目标入组 255 人开始时间: 2021年1月22日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 255
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
- •XML File Identifier: Vjfu/bRaIlcBdlVvThjEUIpekBU=
- •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
- •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;
- •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.
- 另有 11 项未显示
排除标准
- •1. Subject has any significant medical condition, laboratory abnormality,
- •or psychiatric illness that would prevent the subject from participating in
- •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.
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