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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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)

Conditions
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Recurrent Vulvovaginal Candidiasis

Intervention / Treatment
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* Drug: Fluconazole Tablet
* Drug: IBREXAFUNGERP
* Drug: Placebo oral tablet


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Open label (acute phase treatment) followed by Randomized, Double Blinded phase
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ibrexafungerp<br>Oral Fluconazole 150 mg every 72 hours for 3 doses followed by Oral Ibrexafungerp 300 mg BID (one day) every 4 weeks for a total of 6 dosing days | Drug: Fluconazole Tablet<br>* 150 mg every 72 hours for 3 doses<br>Drug: IBREXAFUNGERP<br>* 300 mg BID (one day) every 4 weeks for a total of 6 dosing days<br>* Other names: SCY-078;|
| Placebo Comparator: Placebo<br>Oral Fluconazole 150 mg every 72 hours for 3 doses followed by Oral Placebo BID (one day) every 4 weeks for a total of 6 dosing days | Drug: Fluconazole Tablet<br>* 150 mg every 72 hours for 3 doses<br>Drug: Placebo oral tablet<br>* BID (one day) every 4 weeks for a total of 6 dosing days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Success | Efficacy as measured by the percentage of subjects with documented Clinical Success. | Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Percentage of Subjects With no Mycologically Proven Recurrence | Efficacy as measured by the percentage of subjects with no Mycologically Proven Recurrence | Week 24 | 
| Safety and Tolerability | Safety as measured by the number of subjects who discontinue due to treatment related adverse events. | Week 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Recurrent yeast infection, Recurrent yeast vaginitis, Chronic yeast vaginitis, Ibrexafungerp, SCY-078, RVVC