EUCTR2006-000057-22-DE进行中（未招募）不适用
A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Comparison Study of CC-10004 in Subjects with Moderate-to-severe Plaque-Type Psoriasis
Celgene Corporation, Inc.0 个研究点目标入组 255 人开始时间: 2006年3月7日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 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.Must understand and voluntarily sign an informed consent form
- •2.Must be a male or female of any ethnic origin or race, aged 18 years or older at time of consent
- •3.Must be in good health as judged by the investigator, based on medical history, physical examination, 12-lead ECG, serum chemistry, hematology, and urinalysis
- •4.Must be able to adhere to the study visit schedule and other protocol requirements
- •5.Must have a =6-month history of moderate-to-severe plaque-type psoriasis immediately prior to enrollment. Note that the severity must have been moderate-to-severe during the entire 6-month period before screening
- •6.Must have a PASI score =10 and BSA =10%
- •7.Must meet the following laboratory criteria:
- •a.White blood cell count =3000/mm3 (=3.0 X 10^9/L) and < 20,000/mm3 (<20 X 10^9/L)
- •b.Platelet count =100,000/µL (=100 X 10^9/L)
- •c.Serum creatinine =1.5 mg/dl (=132.6 µmol/L)
- •d.AST (SGOT) and ALT (SGPT) =1.5 X upper limit of normal (ULN)
- •8.Must be a candidate for photo/systemic therapy (a subject is considered a candidate for photo/systemic therapy if in the judgment of a clinician the subject requires any systemic therapy, e.g., ultraviolet light A [UVA], ultraviolet light B [UVB], psoralens and long-wave ultraviolet radiation [PUVA], cyclosporine, corticosteroids, methotrexate, oral retinoids, mycophenolate mofetil, thioguanine, hydroxyurea, sirolimus, tacrolimus, azathioprine, or biological agents to control psoriasis whether or not that subject has a history of receiving systemic therapy).
- •9.Women of childbearing potential (WCBP)* must have a negative urine pregnancy test at screening (Visit 1). In addition, sexually active WCBP must agree to use two of the following adequate forms of contraception methods such as: oral, injectable or implantable hormonal contraception; tubal ligation; intrauterine device; barrier contraceptive with spermicide or vasectomized partner while on study. A WCBP must agree to have pregnancy tests every 4 weeks while on study medication.
- •10.Males (including those who have had a vasectomy) must agree to use barrier contraception (latex condoms) when engaging in reproductive sexual activity with WCBP while on study medication and for 4 weeks after taking the last dose of study medication
- •*A woman of child bearing potential is a sexually mature woman who has not undergone a hysterectomy or who has not been naturally postmenopausal for at least 24 consecutive months (i.e., women who have had menses at any time in the preceding 24 consecutive months)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Must not have a history of clinically significant (as determined by the investigator) cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic disease, or other major disease
- •2.Must not be pregnant or lactating females
- •3.Must not have any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study
- •4.Must not have a history of active mycobacterium tuberculosis infection (any subspecies) within 3 years prior to the screening visit
- •5.Must not have a history of incompletely treated active or latent mycobacterium tuberculosis (any subspecies) infection
- •6.Must not have a known history of exposure to an infectious case (smear-positive) of mycobacterium tuberculosis within 2 years prior to the screening visit
- •7.Must not be an immigrant from a high-incidence country for mycobacterium tuberculosis disease within 2 years prior to the screening visit (see Appendix 21.7 for a listing of countries at high risk for mycobacterium tuberculosis disease)
- •8.Must not have current erythrodermic, guttate, or pustular psoriasis
- •9.Must not have a clinical history of failure to adequately respond to treatment in the investigator’s opinion to one or more treatment courses of cyclosporine or the following biologic therapies: alefacept, etanercept, efalizumab, infliximab or adalimumab
- •10.Must not use topical therapy (including but not limited to topical steroids, topical vitamin A or D analog preparations, tacrolimus, pimecrolimus, or anthralin) within 14 days of randomization. (Exception: moderate-to-low potency corticosteroids will be allowed for treatment of the palms, face, plantar surfaces, axillae and groin in accordance with the manufacturers suggested usage during the course of the study)
- •11.Must not use systemic therapy for psoriasis (including but not limited to cyclosporine, corticosteroids, methotrexate, oral retinoids, mycophenolate mofetil, thioguanine, hydroxyurea, sirolimus, tacrolimus, azathioprine, fumaric acid esters) within 28 days of randomization
- •12.Must not use phototherapy (UVA, UVB, PUVA) within 28 days of randomization
- •13.Must not use adalimumab or infliximab within 3 months of randomization
- •14.Must not use etanercept or efalizumab within 56 days of randomization
- •15.Must not use alefacept within 6 months of randomization
- •16.Must not use any investigational drug within 30 days of randomization
- •19.Must not have a clinically significant abnormality on 12-lead ECG at screening
- •20.No known HIV, Hepatitis B or Hepatitis C infection
- •21.Must not have a history of malignancy within 5 years prior to the screening visit (except basal cell carcinoma or < 3 squamous-cell carcinomas of the skin)
- •22.Must not have evidence of skin conditions that would interfere with evaluations of the effect of study medication on psoriasis
研究者
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