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

Study Overview
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Brief Summary
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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
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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.

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) vs. Placebo in Subjects With Acute Vulvovaginal Candidiasis

Conditions
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Candida Vulvovaginitis

Intervention / Treatment
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* Drug: Ibrexafungerp
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is a postmenarchal female subject 12 years and older Subject has a diagnosis of symptomatic AVVC at baseline including a positive microscopic examination with 10% KOH in a vaginal sample revealing yeast forms (hyphae/pseudohyphae) or budding yeasts, and vaginal pH (≤4.5) Exclusion Criteria: Subject has any vaginal condition other than AVVC that may interfere with the diagnosis or evaluation of response to therapy, such as suspected or confirmed concurrent causes of vulvovaginitis and/or cervicitis (mixed infection) Need for systemic and/or topical (vaginal) antifungal treatment, including prescription or over-the-counter products during the study and treatment for VVC 28 days prior to randomization Subject is actively menstruating at the time of the Baseline visit. Subject has uncontrolled diabetes mellitus. Subject has a vaginal sample with pH >4.5. Subject has a history of or an active cervical/vaginal cancer.

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomized, placebo-controlled, double-blind study
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ibrexafungerp (SCY-078)<br>300 mg orally every 12 hrs for 1 day (2 doses in 1 day) | Drug: Ibrexafungerp<br>* Ibrexafungerp 300 mg BID for 1 day<br>* Other names: SCY-078;|
| Placebo Comparator: Placebo<br>Matching Placebo | Drug: Placebo<br>* Matching placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Cure (Complete Resolution of Signs and Symptoms) | measured by the percentage of subjects with clinical cure (complete resolution of signs and symptoms) at the test-of-cure (TOC) visit | Day 8-14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mycological Eradication (Negative Culture for Growth of Yeast) | percentage of subjects with mycological eradication (negative culture for growth of Candida species) at the TOC visit | Day 8-14 | 
| Clinical Cure and Mycological Eradication (Responder Outcome) | percentage of subjects with clinical cure and mycological eradication (responder outcome) at the TOC visit | Day 8-14 | 
| Complete Clinical Response at Follow-Up | percentage of subjects with complete resolution of signs and symptoms at the Follow-up (FU) visit | Day 25 | 
| Overall Treatment-Emergent Adverse Events (Safety Set) | Number of subjects with treatment related adverse events | Up to 29 days |