A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of VT-1161 Oral Tablets in the Treatment of Patients With Distal Lateral Subungual Onychomycosis of the Toenail
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 259
- 试验地点
- 27
- 主要终点
- The Proportion of Subjects in the Intent-to-treat Population With Complete Cure, Defined as Clinical AND Mycological Cure, at Week 48
研究概览
简要总结
Several properties of VT-1161 suggest that it might be a safer and more effective treatment for onychomycosis of the toenail (also known as toenail fungus) than other oral antifungal medicines.
This study will evaluate the effectiveness and safety of VT-1161 for the treatment of toenail onychomycosis and consists of a screening phase, a 24-week treatment phase in which the patient will take either active drug, placebo or a combination of the 2 (according to random assignment), an initial observational phase of 36 weeks and an additional observational study extension of 9 months.
The additional 9-month observational study extension was added with a protocol amendment and patient participation was optional.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Distal subungual onychomycosis of the great toenail, affecting at least ≥25 to ≤75% of nail.
- •Positive culture for dermatophytes and positive KOH.
- •Nail ≤ 3 mm thick at the distal end.
- •At least ≥ 2 mm of the proximal end of the great toenail must be free of infection.
- •Subjects must be able to swallow tablets.
- •Women of childbearing potential and males must use acceptable birth control methods throughout the study.
排除标准
- •Presence of subungual hematoma or melanonychia.
- •Presence of dermatophytoma/nail streaks and severe onychorrhexis.
- •Significant dystrophy or anatomic abnormalities of the great toenail.
- •Presence of any other infections of the foot.
- •Evidence of clinically significant major organ disease.
- •Poorly controlled diabetes mellitus.
- •Onychomycosis involving more than 8 toe nails.
- •Recent use of systemic antifungal therapy.
- •Recent of any topical antifungal nail therapy.
- •Recent use of systemic corticosteroid therapy.
- •Recent use of immunosuppressive medication.
- •History of prolonged QT intervals.
- •Known human immunodeficiency virus (HIV) infection.
- •Known significant renal or hepatic impairment.
- •Known history of intolerance or hypersensitivity to azole antifungal drugs.
研究组 & 干预措施
Low dose 12-week
2 VT-1161 150mg tablets and 2 placebo tablets once daily for 2 weeks, then once weekly for 10 weeks, followed by 4 placebo tablets once weekly for 12 weeks
干预措施: VT-1161 (Drug)
Low dose 24-week
2 VT-1161 150mg tablets and 2 placebo tablets once daily for 2 weeks, then once weekly for 22 weeks
干预措施: VT-1161 (Drug)
High dose 12-week
4 VT-1161 150mg tablets once daily for 2 weeks, then once weekly for 10 weeks, followed by 4 placebo tablets once weekly for 12 weeks
干预措施: VT-1161 (Drug)
High dose 24-week
4 VT-1161 150mg tablets once daily for 2 weeks, then once weekly for 22 weeks
干预措施: VT-1161 (Drug)
Placebo
4 placebo tablets once daily for 2 weeks, then once weekly for 22 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
The Proportion of Subjects in the Intent-to-treat Population With Complete Cure, Defined as Clinical AND Mycological Cure, at Week 48
时间窗: 48 weeks
Complete cure was defined as 0% nail involvement and an Investigator Global Assessment (IGA) score of 0. Mycological cure was defined as negative potassium hydroxide (KOH) and negative dermatophyte culture. Investigator Global Assessment (IGA) scoring: 0: 0% nail involvement 1. \>0% to ≤10% nail involvement 2. \>10% to \<25% nail involvement 3. ≥25% to ≤50% nail involvement 4. \>50% to ≤75% nail involvement 5. \>75% nail involvement
Study Extension - Number of Subjects Who Experienced Treatment-emergent Adverse Events and Lab Abnormalities
时间窗: 9 months
次要结局
未报告次要终点