NCT03734991

Efficacy and Safety of Oral Ibrexafungerp (SCY-078) vs. Placebo in Subjects With Acute Vulvovaginal Candidiasis (VANISH 303)

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 376 (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 for 1 day * Oral ibrexafungerp matching placebo BID for 1 day Subjects will receive their first dose of study drug at the site and will be dispensed the second dose for self-administration at home 12 hours after the first dose. Study Blinding, Randomization and Stratification: This is a randomized, double-blind study. All site and sponsor personnel will be blinded to treatment assignment. Approximately 366 eligible subjects will be enrolled and randomized in a 2:1 ratio to one of the two study treatment groups. For the purpose of maintaining treatment blinding, all subjects randomized to the placebo group will receive matching ibrexafungerp placebo tablets.

Conditions

• Candida Vulvovaginitis

Interventions

Type	Name	Description
DRUG	Ibrexafungerp	Ibrexafungerp 300 mg BID for 1 day
DRUG	Placebo	Matching placebo

Timeline

• Start date: 2019-01-04
• Primary completion: 2019-08-21
• Completion: 2019-09-04
• First posted: 2018-11-08
• Last updated: 2021-09-08
• Results posted: 2021-09-08

Locations

25 sites across 1 country: United States

Regulatory

• FDA-regulated drug study