A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Ibrexafungerp (SCY-078) vs. Placebo in Subjects With Acute Vulvovaginal Candidiasis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 376
- 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 Phase 3, randomized, multicenter, double-blind, placebo-controlled study to evaluate the efficacy and safety of oral Ibrexafungerp (SCY-078) compared to placebo in female subjects 12 years and older with AVVC.
详细描述
Subjects who meet all of the inclusion and none of the exclusion criteria will be enrolled into the study and will be randomized in a 2:1 ratio to either oral ibrexafungerp or ibrexafungerp matching placebo, as follows:
- Oral ibrexafungerp 300-mg dose BID for 1 day
- Oral ibrexafungerp matching placebo BID for 1 day
Subjects will receive their first dose of study drug at the site and will be dispensed the second dose for self-administration at home 12 hours after the first dose. Study Blinding, Randomization and Stratification: This is a randomized, double-blind study.
All site and sponsor personnel will be blinded to treatment assignment. Approximately 366 eligible subjects will be enrolled and randomized in a 2:1 ratio to one of the two study treatment groups. For the purpose of maintaining treatment blinding, all subjects randomized to the placebo group will receive matching ibrexafungerp placebo tablets.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Subject is a postmenarchal female subject 12 years and older
- •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
Ibrexafungerp (SCY-078)
300 mg orally every 12 hrs for 1 day (2 doses in 1 day)
干预措施: Ibrexafungerp (Drug)
Placebo
Matching Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Clinical Cure (Complete Resolution of Signs and Symptoms)
时间窗: Day 8-14
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
- Clinical Cure and Mycological Eradication (Responder Outcome)(Day 8-14)
- Overall Treatment-Emergent Adverse Events (Safety Set)(Up to 29 days)
- Mycological Eradication (Negative Culture for Growth of Yeast)(Day 8-14)
- Complete Clinical Response at Follow-Up(Day 25)