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

• Status: Active, not recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: Female

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Scynexis, Inc.
• Treatments: Fluconazole; Ibrexafungerp

Criteria

Key Inclusion Criteria:

• Diagnosis of symptomatic VVC with microscopic examination with KOH positive for yeast and normal vaginal pH.

• History of 3 or more episodes of VVC in the past 12 months.

• Culture confirmation and resolution of the signs and symptoms of the initial VVC episode (with treatment).

• Able to take oral tablets and capsules.

Key exclusion Criteria:

• Vaginal conditions other than recurrent VVC that may interfere with the diagnosis or evaluation of response to therapy.

• Recent use of systemic and/or topical vaginal antifungal products.

• Pregnant.

• History of major system organ disease.