A 12-Week, Exploratory, Open-Label, Nonrandomized, Dose-Escalation Study of the Efficacy, Safety and Tolerability of Oral CEP-701 in Patients With Severe, Recalcitrant, Plaque Type Psoriasis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 3
- 主要终点
- Physicians Static Global (PSGA) Score
研究概览
简要总结
A 12-Week, Exploratory, Open-Label, Nonrandomized, Dose-Escalation Study of the Efficacy, Safety and Tolerability of Oral CEP-701 in Patients with Severe, Recalcitrant, Plaque Type Psoriasis.
详细描述
A 12-Week, Exploratory, Open-Label, Nonrandomized, Dose-Escalation Study of the Efficacy, Safety and Tolerability of Oral CEP-701 in Patients with Severe, Recalcitrant, Plaque Type Psoriasis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients are included in the study if all of the following criteria are met:
- •the patient is at least 21 years old.
- •The patient has sever, recalcitrant, plaque-type psoriasis and has failed at least 1 systemic therapy (for the purposes of this study psoralen with ultraviolet light A is considered to be a systemic therapy).
- •The patient has psoriatic involvement of at least 10% of BSA.
- •The patient has a PSGA score of 4 or greater.
- •The patient, if a woman, is surgically sterile or 2 years postmenopausal, or if of childbearing potential is currently using a medically accepted method of contraception, and agrees to continue use of this method for the duration of the study (and for 30 days after participation in the study). Acceptable methods of contraception include: abstinence, steroidal contraceptive (oral, transdermal, implanted, or injected) in conjunction with a barrier method, or intrauterine device (IUD).
- •The patient, if a main, is surgically sterile, or if capable of producing offspring, is currently using an approved method of birth control, and agrees to continued use of this method for the duration of the study (and for 60 days after taking the last dose of CEP-701 because of the possible effects on spermatogenesis).
- •The patient must be willing and able to comply with study procedures and restrictions and willing to return to the clinic for the follow-up evaluation as specified in this protocol.
排除标准
- •The patient has received treatment with systemic psoriasis treatments (specifically, retinoids, methotrexate, cyclosporine A, etanercept, efalizumab, other biological agents or other immunomodulators) within 4 weeks, or UV based therapy within 2 weeks, or alefacept within 6 weeks of the planned 1st day of study treatment.
- •The patient has received treatment with potent CYP3A4 inhibitors including cyclosporine, clotrimazole, fluconazole, itraconazole, ketoconazole, voriconazole, erythromycin, clarithromycin, and troleandomycin, human immunodeficiency virus (HIV) protease inhibitors, or nefazodone within 1 week (7 days) of the planned 1st day of study treatment.
- •The patient is currently receiving warfarin.
- •The patient has hypersensitivity to CEP-701 or any component of CEP-
- •The patient has one or more of the following serum chemistry values as determined at the screening visit (visit 1):
- •bilirubin levels greater than 2 times the upper limit of normal (ULN)
- •ALT or AST levels greater than 2 times the ULN
- •serum creatinine levels or more than 2mg/dL
- •The patient requires current treatment for HIV with protease inhibitors.
- •The patient is taking medication for a clinical diagnosis of gastrointestinal ulceration or has experienced melena or hematoemesis in the previous 3 weeks.
- •The patient is a woman who is pregnant or lactating.
- •The patient has received treatment with an investigation drug within 4 weeks of the planned 1st day of study treatment.
研究组 & 干预措施
CEP-701 20mg
Patient Cohort 1
干预措施: CEP-701 20mg (Drug)
CEP-701 40mg
Patient Cohort 2
干预措施: CEP-701 20mg (Drug)
CEP-701 40mg
Patient Cohort 2
干预措施: CEP-701 40mg (Drug)
CEP-701 60mg
Patient Cohort 3
干预措施: CEP-701 20mg (Drug)
CEP-701 60mg
Patient Cohort 3
干预措施: CEP-701 40mg (Drug)
CEP-701 60mg
Patient Cohort 3
干预措施: CEP-701 60mg (Drug)
CEP-701 80mg
Patient Cohort 4
干预措施: CEP-701 20mg (Drug)
CEP-701 80mg
Patient Cohort 4
干预措施: CEP-701 40mg (Drug)
CEP-701 80mg
Patient Cohort 4
干预措施: CEP-701 60mg (Drug)
CEP-701 80mg
Patient Cohort 4
干预措施: CEP-701 80mg (Drug)
结局指标
主要结局
Physicians Static Global (PSGA) Score
时间窗: 87 Days
The primary objective of the study is to evaluate the efficacy of oral escalating dosages of CEP-701 at 20, 40, 60, and 80 mg given twice daily (bid) in achieving complete or nearly clearing of psoriasis in patients with severe, recalcitrant, plaque-type psoriasis, as assessed by the Physicians Static Global (PSGA) at baseline and at the end of treatment. A PSGA score of 0 is defined as no evidence of plaque elevation, no evidence of erythema, and no evidence of scaling. A PSGA score of 5 is defined as plaque elevation (2.5 mm or greater)dusky to deep red coloration, very thick tenacious scale predominates.
次要结局
- PSGA Change from Baseline(87 days)
- Psoriasis Area and Severity Index (PASI)(87 Days)