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

Scynexis, Inc.440 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

440

Conditions

Recurrent Vulvovaginal Candidiasis

Interventions

Fluconazole TabletDRUG

150 mg every 72 hours for 3 doses

IBREXAFUNGERPDRUG

300 mg BID (one day) every 4 weeks for a total of 6 dosing days

Placebo oral tabletDRUG

BID (one day) every 4 weeks for a total of 6 dosing days

Eligibility

Sex: FEMALEMin age: 12 Years

Medical Language ↔ Plain English

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.

Locations (25)

Outcomes

Primary Outcomes

Clinical Success

Efficacy as measured by the percentage of subjects with documented Clinical Success.

Time frame: Week 24

Secondary Outcomes

The Percentage of Subjects With no Mycologically Proven Recurrence

Efficacy as measured by the percentage of subjects with no Mycologically Proven Recurrence

Time frame: Week 24

Safety and Tolerability

Safety as measured by the number of subjects who discontinue due to treatment related adverse events.

Time frame: Week 24

Data from ClinicalTrials.gov

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