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 (AVVC).
Overview
- Phase
- Phase 3
- Intervention
- Ibrexafungerp
- Conditions
- Candida Vulvovaginitis
- Sponsor
- Scynexis, Inc.
- Enrollment
- 455
- Locations
- 40
- Primary Endpoint
- Clinical Cure (Complete Resolution of Signs and Symptoms)
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
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.
Detailed Description
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 (bis in die) for 1 day * Oral ibrexafungerp matching placebo BID for 1 day This is a randomized, double-blind study. Approximately 366 eligible subjects will be enrolled and randomized in a 2:1 ratio to one of the two study treatment groups. Subjects will be followed for assessments of efficacy and safety for approximately one month after study drug administration. The design of this study is identical to VANISH 303 Study: NCT03734991
Investigators
Eligibility Criteria
Inclusion Criteria
- •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% Potassium Hydroxide (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) anti fungal treatment, including prescription or over-the-counter products during the study and treatment for vulvovaginal candidiasis (VVC) 28 days prior to randomization.
- •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
Ibrexafungerp (SCY-078)
300 mg BID for one day
Intervention: Ibrexafungerp
Placebo
Matching Placebo
Intervention: Placebo
Outcomes
Primary Outcomes
Clinical Cure (Complete Resolution of Signs and Symptoms)
Time Frame: Day 8-14
The percentage of subjects with clinical cure (complete resolution of signs and symptoms) at the test-of-cure (TOC) visit
Secondary Outcomes
- Complete Clinical Response at Follow-up(Day 25)
- Mycological Eradication (Negative Culture for Growth of Yeast)(Day 8-14)
- Clinical Cure and Mycological Eradication (Responder Outcome)(Day 8-14)
- Safety and Tolerability of Ibrexafungerp(Up to 29 Days)