A Multicenter, Randomized, Evaluator Blinded, Active-Controlled Study to Evaluate the Safety and Efficacy of Oral Ibrexafungerp (SCY-078) vs. Oral Fluconazole in Subjects With Vulvovaginal Candidiasis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 2
- 主要终点
- Proportion of subjects achieving therapeutic cure at the test of cure visit (Day 24 +/-3)
研究概览
简要总结
This is a randomized, multicenter, evaluator blinded study to evaluate the safety, tolerability, efficacy and pharmacokinetics of SCY-078 compared to Fluconazole in adult patients with moderate to severe Vulvovaginal Candidiasis (VVC) and a history of frequent episodes of VVC. Approximately 90 subjects, meeting the inclusion criteria will be enrolled and randomized in a 1:1:1 ratio to one of the 3 treatment arms: Oral SCY-078 in 2 dose regimens or oral Fluconazole. After enrollment, subjects will be evaluated on Day-5 (end of treatment visit), Day-24 (test of cure visit), Day-60, Day 90 and Day 120 (end of observation period visit) or at any time that a recurrence or clinical failure is suspected, up to the end of observation period.
详细描述
This is a randomized, multicenter, evaluator blinded study to evaluate the safety, tolerability, efficacy and pharmacokinetics of SCY-078 compared to Fluconazole in adult patients, from 18 to 65 years of age, with moderate to severe Vulvovaginal Candidiasis (VVC) and a history of frequent episodes of VVC. Approximately 90 subjects, meeting the inclusion criteria will be enrolled and randomized in a 1:1:1 ratio to one of the 3 treatment arms: oral SCY-078 does regimen 1, or oral SCY-078 does regimen 2, or oral Fluconazole. After enrollment, subjects will be evaluated on Day-5 (end of treatment visit), Day-24 (test of cure visit), Day-60, Day 90 and Day 120 (end of observation period visit) or at any time that a recurrence or clinical failure is suspected, up to the end of observation period.
Primary Objectives:
* To evaluate the safety and efficacy of 2 dosing regimens of Oral SCY-078 in subjects with moderate to severe Vulvovaginal Candidiasis (VVC)
Secondary Objectives:
* To estimate the effect of Oral SCY-078 therapy in the rate and time to recurrence in subjects with a history of frequent episodes of VVC
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
- Single (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
- •Subjects must fulfill all of the following criteria to be eligible for study admission:
- •Female subjects from 18 to 65 years of age in good general health
- •Diagnosis of symptomatic moderate to severe vulvovaginal candidiasis
- •The ability to understand and sign a written informed consent form (ICF), which must be obtained prior to treatment and any study-related procedures.
- •The ability to understand and sign a consent or authorization form which shall permit the use, disclosure and transfer of the subject's personal health information (e.g., in the U.S. HIPAA Authorization form).
- •The ability to understand and follow all study-related procedures including study drug administration.
- •Females of childbearing potential must agree to use a medically acceptable method of contraception while receiving protocol-assigned product.
排除标准
- •A subject will be excluded from participation in the study if she meets any of the following exclusion criteria:
- •Any vaginal condition other than VVC that may interfere with the diagnosis or evaluation of response to therapy.
- •Prior use of any prohibited medication(s) or procedure(s) within the protocol specified timeframe including:
- •a. Systemic and/or topical (vaginal) antifungal treatment, prescription or over the counter, within 30 days of the baseline visit.
- •Subjects with history of renal impairment, hepatic impairment or cervical cancer.
- •4 Subjects with known hypersensitivity to enfumafungin derivatives, fluconazole or any of the components of the formulation.
- •HIV infection, chemotherapy or illness serious enough to induce an immune deficiency.
研究组 & 干预措施
Treatment Group 1 (Fluconazole)
Fluconazole
干预措施: Fluconazole (Drug)
Treatment Group 2: (SCY-078)
Dose regimen 1
干预措施: SCY-078 (Drug)
Treatment Group 3 (SCY-078)
Dose regimen 2
干预措施: SCY-078 (Drug)
结局指标
主要结局
Proportion of subjects achieving therapeutic cure at the test of cure visit (Day 24 +/-3)
时间窗: Day 24 +/- 3
Therapeutic Cure defined as achieving both a Clinical Cure (resolution of signs and symptoms) and a Mycological Eradication (negative culture).
次要结局
- Proportion of subjects with recurrence of VVC during the observation period(4-month observation period)