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
Overview
- Phase
- Phase 2
- Intervention
- Fluconazole
- Conditions
- Candida Vulvovaginitis
- Sponsor
- Scynexis, Inc.
- Enrollment
- 186
- Locations
- 24
- Primary Endpoint
- Clinical Cure (Complete Resolution of Signs and Symptoms)
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
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.
Detailed Description
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).
Investigators
Eligibility Criteria
Inclusion Criteria
- •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)
Exclusion Criteria
- •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.
Arms & Interventions
Fluconazole
150 mg/day for 1 day
Intervention: Fluconazole
Ibrexafungerp 750mg
750mg QD for 1 day only
Intervention: SCY-078
Ibrexafungerp 300mg
300mg BID for 1 day only
Intervention: SCY-078
Ibrexafungerp 450mg
450mg BID for 1 day only
Intervention: SCY-078
Ibrexafungerp 150mg
150mg BID for 3 days
Intervention: SCY-078
Ibrexafungerp 300mg D1-D3
300mg BID for 3 days
Intervention: SCY-078
Outcomes
Primary Outcomes
Clinical Cure (Complete Resolution of Signs and Symptoms)
Time Frame: 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
Secondary Outcomes
- Co-occurrence of Clinical and Mycological Cure(29 days)