EUCTR2010-024196-83-BG进行中（未招募）不适用
A Phase 2/3 Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study of the Efficacy and Safety of Daily CF101 Administered Orally in Patients with Moderate-to-Severe Plaque Psoriasis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 291
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.Male or female, 18 to 80 years of age, inclusive;
- •2.Diagnosis of moderate-to-severe chronic plaque-type psoriasis with BSA involvement =10%, as judged by the Investigator;
- •3.Duration of psoriasis of at least 6 months;
- •4.PGA =3 (Appendix 2);
- •5.Candidate for systemic treatment or phototherapy for psoriasis;
- •6.Electrocardiogram (ECG) is normal or shows abnormalities which, in the judgment of the Investigator, are not clinically significant;
- •7.Females of child-bearing potential must have a negative serum pregnancy test at screening;
- •8.Females of child-bearing potential must be willing to use 2 methods of contraception deemed adequate by the Investigator (for example, oral contraceptive pills plus a barrier method) to be eligible for, and continue participation in, the study;
- •9.Ability to complete the study in compliance with the protocol; and
- •10.Ability to understand and provide written informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 221
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 70
排除标准
- •1.Erythrodermic, guttate, palmar, plantar, or generalized pustular psoriasis;
- •2.Treatment with systemic retinoids, corticosteroids, or immunosuppressive agents (e.g., methotrexate, cyclosporine) within 4 weeks of the Baseline visit;
- •3.Treatment with high potency topical dermatological corticosteroids (Class I-III), Vitamin D analogs, keratolytics, or coal tar (other than on the scalp, palms, groin, and/or soles) within 2 weeks of the Baseline visit;
- •4.Ultraviolet or Dead Sea therapy within 4 weeks of the Baseline visit, or anticipated need for either of these therapies during the study period;
- •5.Treatment with a biological agent (etanercept, adalimumab, efalizumab, infliximab, ustekinumab, alefacept or others, including investigational agents) within a period of time equal to 5 times its circulating half-life, or 30 days, whichever is longer, prior to the Baseline visit;
- •6.Treatment with lithium, hydroxychloroquine or chloroquine within 2 weeks of the Baseline visit, or anticipated need for such drugs during the study period, unless dose has been stable for 3 months prior to the Screening visit and will remain stable throughout the trial;
- •7.Serum creatinine level greater than 1.5 times the laboratory’s upper limit of normal;
- •8.Liver aminotransferase levels greater than the laboratory’s upper limit of normal;
- •9.Pregnancy, planned pregnancy, lactation, or inadequate contraception as judged by the Investigator;
- •10.Active drug or alcohol dependence;
- •11.Previous receipt of CF101;
- •12.Significant acute or chronic medical or psychiatric illness that, in the judgment of the Investigator, could compromise subject safety, limit the subject’s ability to complete the study, and/or compromise the objectives of the study;
- •13.Participation in another investigational drug or vaccine trial concurrently or within 30 days prior to Screening visit.
研究者
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