NCT04029116

Phase 3 Study of Oral Ibrexafungerp (SCY-078) Vs. Placebo in Subjects With Recurrent Vulvovaginal Candidiasis (VVC)

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Ibrexafungerp (SCY-078) Compared to Placebo in Subjects With Recurrent Vulvovaginal Candidiasis (VVC)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 440 (actual)
• Sponsor: Scynexis, Inc. · Industry
• Sex: Female
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

This study is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of oral ibrexafungerp (formerly "SCY-078") compared to placebo in female subjects 12 years and older with recurrent VVC (RVVC).

Detailed description

This study is a Phase 3, multicenter, randomized, double-blind study to evaluate the efficacy and safety of oral ibrexafungerp (formerly "SCY-078") compared to placebo in female subjects 12 years and older with RVVC. The primary objective of the study is to evaluate the efficacy of oral ibrexafungerp in preventing recurrences of VVC in subjects with RVVC based on Clinical Success. Approximately 320 subjects are planned to be enrolled into the study. All subjects will receive treatment with oral fluconazole for their acute episode present at screening. Subjects who respond to fluconazole for their acute episode will be enrolled in the prevention of recurrence phase of the study and randomized to ibrexafungerp or placebo. Subjects who fail treatment with fluconazole for their acute episode will be included in a nested open label Sub-Study, in which they will be offered one-day oral ibrexafungerp for their unresolved acute episode.

Conditions

• Recurrent Vulvovaginal Candidiasis

Interventions

Type	Name	Description
DRUG	Fluconazole Tablet	150 mg every 72 hours for 3 doses
DRUG	IBREXAFUNGERP	300 mg BID (one day) every 4 weeks for a total of 6 dosing days
DRUG	Placebo oral tablet	BID (one day) every 4 weeks for a total of 6 dosing days

Timeline

• Start date: 2019-10-21
• Primary completion: 2021-09-01
• Completion: 2021-11-29
• First posted: 2019-07-23
• Last updated: 2023-06-18
• Results posted: 2023-06-18

Locations

25 sites across 1 country: United States

Regulatory

• FDA-regulated drug study