NCT01001468已完成2 期
A Randomized, Double-Blind, 12-Week, Dose-Ranging Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral VB-201 in Patients With Moderate to Severe Plaque Psoriasis
Vascular Biogenics Ltd. operating as VBL Therapeutics18 个研究点 分布在 3 个国家目标入组 185 人开始时间: 2009年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 185
- 试验地点
- 18
- 主要终点
- Improvement in the Psoriasis Area and Severity Index(PASI 75)from baseline at Week 12
研究概览
简要总结
The purpose of this study is to examine the efficacy, safety and tolerability of VB-201 as compared with placebo on measures of disease activity in patients with psoriasis.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female Patients, ≥18 to ≤75 years of age, who have a diagnosis of chronic plaque psoriasis for at least 6 months
- •Non-anorexic subjects with a BMI ≥20
- •Psoriasis Area and Severity Index (PASI) score of ≥12
- •Plaque psoriasis covering ≥10% of body surface area (BSA)
- •Psoriasis severity at least moderate, scoring at least 3 on the 0 to 5 point Physician Global Assessment (PGA) scale
排除标准
- •The subject presents with the predominant type of psoriasis as guttate, erythrodermic, inverse, pustular or palmo-plantar or an unstable form of psoriasis
- •The subject has not undergone wash-out periods of sufficient duration for the following treatments at Baseline: Topical psoriasis treatments; Systemic, oral or injected, psoriasis treatments; Phototherapy
- •The subject anticipates getting enough ultra-violet light during the study to cause psoriasis to improve
- •The subject has a known allergy or sensitivity to the study treatment(s) or to any of the excipients contained in the study drug formulation
- •History of cancer, the exception is skin cancer
- •Has a clinically significant systemic infection within 30 days of Day 0, or a history or presence of recurrent or chronic infection
- •Evidence of tuberculosis as indicated by a positive tuberculin skin test or a quantiferon test in subjects known to have a + PPD and a negative chest x-ray at screening
- •History of clinically significant hypoglycemia
- •Subjects with currently active peptic ulcer / gastroesophageal reflux disease
研究组 & 干预措施
VB-201 20 mg
Experimental
干预措施: VB-201 (Drug)
VB-201 80 mg
Experimental
干预措施: VB-201 (Drug)
Placebo
Placebo Comparator
Single daily dose of oral placebo
干预措施: Placebo (Other)
结局指标
主要结局
Improvement in the Psoriasis Area and Severity Index(PASI 75)from baseline at Week 12
时间窗: 20 weeks
次要结局
- Change in PGA (Physician Global Assessment) scores from baseline to Week 12(20 weeks)
- Change in Patient Psoriasis Global Assessment scores from baseline to Week 12(20 weeks)
- Change in affected Body Surface Area (BSA) from baseline to Week 12(20 weeks)
- Measurement of improvement in the PASI (50) from baseline at Week 12(20 weeks)
研究者
研究点 (18)
Loading locations...
相似试验
已完成
2 期
Study to Assess the Safety and Efficacy of Multiple Doses of VB-201 on BiomarkersBiomarkerNCT01159730Vascular Biogenics Ltd. operating as VBL Therapeutics320
已完成
2 期
A Study to Evaluate the Efficacy and Safety of VIB4920 in Participants With Sjögren's SyndromeSjögren's SyndromeNCT04129164Amgen183
终止
2 期
A Phase 2 Study to Evaluate the Efficacy and Safety of VIR-2482 for the Prevention of Illness Due to Influenza AInfluenza ANCT05567783Vir Biotechnology, Inc.2,985
已完成
2 期
High Dose Trial in COPDPulmonary Disease, Chronic ObstructiveNCT00128440Boehringer Ingelheim78
终止
2 期
A Study to Assess Efficacy, Safety, Tolerability, and Pharmacokinetics of ABBV-8E12 in Subjects With Progressive Supranuclear Palsy (PSP)Progressive Supranuclear PalsyNCT02985879AbbVie378