A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Ibrexafungerp (SCY-078) Compared to Placebo in Subjects With Recurrent Vulvovaginal Candidiasis (VVC)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 440
- 试验地点
- 25
- 主要终点
- Clinical Success
研究概览
简要总结
This study is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of oral ibrexafungerp (formerly "SCY-078") compared to placebo in female subjects 12 years and older with recurrent VVC (RVVC).
详细描述
This study is a Phase 3, multicenter, randomized, double-blind study to evaluate the efficacy and safety of oral ibrexafungerp (formerly "SCY-078") compared to placebo in female subjects 12 years and older with RVVC. The primary objective of the study is to evaluate the efficacy of oral ibrexafungerp in preventing recurrences of VVC in subjects with RVVC based on Clinical Success. Approximately 320 subjects are planned to be enrolled into the study. All subjects will receive treatment with oral fluconazole for their acute episode present at screening. Subjects who respond to fluconazole for their acute episode will be enrolled in the prevention of recurrence phase of the study and randomized to ibrexafungerp or placebo.
Subjects who fail treatment with fluconazole for their acute episode will be included in a nested open label Sub-Study, in which they will be offered one-day oral ibrexafungerp for their unresolved acute episode.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of symptomatic VVC with microscopic examination with KOH positive for yeast and normal vaginal pH.
- •History of 3 or more episodes of VVC in the past 12 months.
- •Culture confirmation and resolution of the signs and symptoms of the initial VVC episode (with treatment).
- •Able to take oral tablets and capsules.
- •Key exclusion Criteria:
- •Vaginal conditions other than recurrent VVC that may interfere with the diagnosis or evaluation of response to therapy.
- •Recent use of systemic and/or topical vaginal antifungal products.
- •Pregnant.
- •History of major system organ disease.
排除标准
- 未提供
研究组 & 干预措施
Ibrexafungerp
Oral Fluconazole 150 mg every 72 hours for 3 doses followed by Oral Ibrexafungerp 300 mg BID (one day) every 4 weeks for a total of 6 dosing days
干预措施: Fluconazole Tablet (Drug)
Ibrexafungerp
Oral Fluconazole 150 mg every 72 hours for 3 doses followed by Oral Ibrexafungerp 300 mg BID (one day) every 4 weeks for a total of 6 dosing days
干预措施: IBREXAFUNGERP (Drug)
Placebo
Oral Fluconazole 150 mg every 72 hours for 3 doses followed by Oral Placebo BID (one day) every 4 weeks for a total of 6 dosing days
干预措施: Fluconazole Tablet (Drug)
Placebo
Oral Fluconazole 150 mg every 72 hours for 3 doses followed by Oral Placebo BID (one day) every 4 weeks for a total of 6 dosing days
干预措施: Placebo oral tablet (Drug)
结局指标
主要结局
Clinical Success
时间窗: Week 24
Efficacy as measured by the percentage of subjects with documented Clinical Success.
次要结局
- The Percentage of Subjects With no Mycologically Proven Recurrence(Week 24)
- Safety and Tolerability(Week 24)