Efficacy and Safety of Oral Ibrexafungerp (SCY-078) vs. Placebo in Subjects With Acute Vulvovaginal Candidiasis — Vanish 306  

Candida Vulvovaginitis Clinical Trial

Official title: 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).

Status Completed

Clinical Trial 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.

Clinical Trial 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 ;

Related Conditions & MeSH terms

• Candida Vulvovaginitis
• Candidiasis
• Candidiasis, Vulvovaginal
• Vulvovaginitis

• NCT number: NCT03987620
• Study type: Interventional
• Source: Scynexis, Inc.
• Status: Completed
• Phase: Phase 3
• Start date: June 7, 2019
• Completion date: April 29, 2020