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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 293
- 试验地点
- 18
- 主要终点
- Number of Subjects Achieving Psoriasis Area and Severity Index (PASI) 75 at 12 Weeks
研究概览
简要总结
Eligible patients with Psoriasis will be treated with CF101 or placebo twice daily for 16 weeks. All subjects will receive open-lable CF101 in weeks 17-32.
详细描述
Eligible patients will be randomly assigned to parallel dosing groups of CF101 2 mg or matching placebo tablets twice daily (BID) in a 1:1 ratio for the 16-week controlled treatment period. Approximately 94 patients will be assigned to each group.
Medication will be taken orally BID for 16 weeks in a double-blinded fashion. At the end of 16 weeks, all patients assigned to CF101 will continue CF101, while patients originally assigned to placebo will be reassigned to CF101.
Assessment of peripheral blood mononuclear cell (PBMC) adenosine A3 receptor (A3AR) expression at baseline and during treatment with CF101 in selected sites.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, 18 to 80 years of age, inclusive
- •Diagnosis of moderate-to-severe chronic plaque-type psoriasis with body surface area involvement ≥10%
- •Duration of psoriasis of at least 6 months
- •Physician global assessment (PGA) ≥3
- •Candidate for systemic treatment or phototherapy for psoriasis
- •Electrocardiogram (ECG) is normal
- •Females of child-bearing potential must have a negative serum pregnancy test
- •Females of child-bearing potential must be willing to use 2 methods of contraception
- •Ability to complete the study in compliance with the protocol
- •Ability to understand and provide written informed consent.
排除标准
- •Erythrodermic, guttate, palmar, plantar, or generalized pustular psoriasis
- •Treatment with systemic retinoids, corticosteroids, or immunosuppressive agents within 4 weeks of the Baseline visit
- •Treatment with high potency topical corticosteroids, keratolytics, or coal tar within 2 weeks of the Baseline visit
- •Ultraviolet or Dead Sea therapy within 4 weeks of the Baseline visit
- •Treatment with a biological agent within a period of time equal to 5 times its circulating half-life
- •Treatment with lithium, hydroxychloroquine or chloroquine within 2 weeks of the Baseline visit
- •Serum creatinine level greater than 1.5 times the laboratory's upper limit of normal
- •Liver aminotransferase levels greater than the laboratory's upper limit of normal
- •Significant acute or chronic medical or psychiatric illness
- •Participation in another investigational drug or vaccine trial concurrently or within 30 days prior to Screening visit.
研究组 & 干预措施
CF101 2 mg
CF101 2mg oral tablets
干预措施: CF101 (Drug)
Placebo
Placebo oral tablets
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Subjects Achieving Psoriasis Area and Severity Index (PASI) 75 at 12 Weeks
时间窗: 12 weeks
Achievement of PASI 75 indicates a 75% reduction in the PASI score, which ranges from 0 (no disease) to 72 (maximal disease)
次要结局
- Numberof Patients Achieving Psoriasis Area and Severity (PASI) Score of 50 or 75(16 weeks)
- Number of Subjects Achieving PGA of 0 or 1(16 weeks)
- Nature and Frequency of Adverse Events(32 weeks)