A Phase 2, Multicenter, Randomized, Double-Blind, Double-Dummy, Active-Controlled, Dose-Finding Study to Compare the Safety and Efficacy of Oral Ibrexafungerp (SCY-078) vs. Oral Fluconazole in Subjects With Acute Vulvovaginal Candidiasis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 186
- 试验地点
- 24
- 主要终点
- Clinical Cure (Complete Resolution of Signs and Symptoms)
研究概览
简要总结
This is a multicenter, randomized, double-blind, double-dummy, active-controlled, dose-finding study to compare the efficacy, safety and tolerability of oral SCY-078 versus oral fluconazole in adult female subjects 18 years and older with moderate to severe Acute Vulvovaginal Candidiasis (AVVC). Approximately 180 eligible subjects (30 subjects per treatment group) will be enrolled and randomized into the study.
详细描述
This is a Phase 2, multicenter, randomized, double-blind, double-dummy, active-controlled, dose-ranging study of female subjects with moderate to severe Acute Vulvovaginal Candidiasis. Subjects will be randomized to either the investigational arm (SCY-078) with 5 different dose regiments ranging from 1 to 3 days of treatment or to the active-control arm (fluconazole) for 1 day of treatment. After randomization subjects may be seen on study Day 3 (on site visit for PK subjects) , Day 10 (±2,) and Day 25 (+4).
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Subject is a female of at least 18 years of age
- •Subject has a diagnosis of symptomatic AVVC at baseline including a positive microscopic examination with 10% KOH in a vaginal sample revealing yeast forms (hyphae/pseudohyphae) or budding yeasts, and vaginal pH (≤4.5)
排除标准
- •Subject has any vaginal condition other than AVVC that may interfere with the diagnosis or evaluation of response to therapy, such as suspected or confirmed concurrent causes of vulvovaginitis and/or cervicitis (mixed infection)
- •Need for systemic and/or topical (vaginal) antifungal treatment, including prescription or over-the-counter products during the study and treatment for VVC 28 days prior to randomization
- •Subject is actively menstruating at the time of the Baseline visit.
- •Subject has uncontrolled diabetes mellitus.
- •Subject has a vaginal sample with pH >4.
- •Subject has a history of or an active cervical/vaginal cancer.
研究组 & 干预措施
Fluconazole
150 mg/day for 1 day
干预措施: Fluconazole (Drug)
Ibrexafungerp 750mg
750mg QD for 1 day only
干预措施: SCY-078 (Drug)
Ibrexafungerp 300mg
300mg BID for 1 day only
干预措施: SCY-078 (Drug)
Ibrexafungerp 450mg
450mg BID for 1 day only
干预措施: SCY-078 (Drug)
Ibrexafungerp 150mg
150mg BID for 3 days
干预措施: SCY-078 (Drug)
Ibrexafungerp 300mg D1-D3
300mg BID for 3 days
干预措施: SCY-078 (Drug)
结局指标
主要结局
Clinical Cure (Complete Resolution of Signs and Symptoms)
时间窗: 8-12 days
Measured by the percentage of subjects with clinical cure (complete resolution of signs and symptoms) at the test-of-cure (TOC) visit
次要结局
- Co-occurrence of Clinical and Mycological Cure(29 days)