NCT03987620

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

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 455 (actual)
• Sponsor: Scynexis, Inc. · Industry
• Sex: Female
• Age: 12 Years
• Healthy volunteers: Not accepted

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

Conditions

• Candida Vulvovaginitis

Interventions

Type	Name	Description
DRUG	Ibrexafungerp	Ibrexafungerp 300mg BID for one day
DRUG	Placebo	Matching Placebo

Timeline

• Start date: 2019-06-07
• Primary completion: 2020-03-29
• Completion: 2020-04-29
• First posted: 2019-06-17
• Last updated: 2021-09-08
• Results posted: 2021-09-08

Locations

41 sites across 2 countries: United States, Bulgaria

Regulatory

• FDA-regulated drug study