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 Recurrent Vulvovaginal Candidiasis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 254
- 试验地点
- 29
- 主要终点
- The Percentage of Subjects With 1 or More Culture-verified Acute VVC Episodes Through Week 48 of the Study in the Intent-to-treat Population.
研究概览
简要总结
VT-1161 is a novel, oral inhibitor of fungal lanosterol demethylase (CYP51). In vitro and in vivo pharmacology studies have demonstrated that VT-1161 is highly active against Candida albicans and also non-albicans Candida species that cause vulvovaginal candidiasis. VT-1161 is highly selective for fungal CYP51, and data suggests that it may avoid the side-effect profile that limits the use of commonly prescribed antifungal agents for the treatment of recurrent yeast infections.
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 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of symptomatic acute VVC
- •3 or more episodes of acute VVC in the past 12 months
- •Positive KOH
- •Minimum composite vulvovaginal signs and symptoms score of ≥3 at Screening
- •Composite vulvovaginal signs and symptoms score of <3 at Baseline
- •Must be able to swallow tablets
排除标准
- •Evidence of major organ system disease
- •Presence or a history of another vaginal or vulvar condition(s)
- •History of cervical cancer
- •Poorly controlled diabetes mellitus
- •Recent use of topical or systemic antifungal drugs
- •Recent use of immunosuppressive or system corticosteroid therapies
研究组 & 干预措施
VT-1161 Low-dose 3-month
1 VT-1161 150mg tablet and 1 placebo tablet once daily for 7 days, then once weekly for 11 weeks, followed by 2 placebo tablet once weekly for 12 weeks
干预措施: VT-1161 (Drug)
VT-1161 Low-dose 6-month
1 VT-1161 150mg tablet and 1 placebo tablet once daily for 7 days, then once weekly for 23 weeks
干预措施: VT-1161 (Drug)
VT-1161 High-dose 3-month
2 VT-1161 150mg tablets once daily for 7 days, then once weekly for 11 weeks, followed by 2 placebo tablet once weekly for 12 weeks
干预措施: VT-1161 (Drug)
VT-1161 High-dose 24-week
2 VT-1161 150mg tablets once daily for 7 days, then once weekly for 23 weeks
干预措施: VT-1161 (Drug)
Placebo
2 placebo tablets once daily for 7 days, then once weekly for 23 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
The Percentage of Subjects With 1 or More Culture-verified Acute VVC Episodes Through Week 48 of the Study in the Intent-to-treat Population.
时间窗: 48 Weeks
A culture-verified acute VVC episode was defined as a positive fungal culture for Candida species associated with a clinical signs and symptoms score of ≥3. To calculate the 'signs and symptoms' score, each vulvovaginal sign (erythema, edema, excoriation) and symptom (itching, burning, irritation) was scored using the following scale, with higher scores indicating a worse outcome. 0 = none (complete absence of any sign or symptom) 1. = mild (slight) 2. = moderate (definitely present) 3. = severe (marked, intense)
次要结局
未报告次要终点