Dose-Finding Study of Oral Ibrexafungep (SCY-078) vs. Oral Fluconazole in Subjects With Acute Vulvovaginal Candidiasis

Study Overview
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Brief Summary
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This is a multicenter, randomized, double-blind, double-dummy, active-controlled, dose-finding study to compare the efficacy, safety and tolerability of oral SCY-078 versus oral fluconazole in adult female subjects 18 years and older with moderate to severe Acute Vulvovaginal Candidiasis (AVVC). Approximately 180 eligible subjects (30 subjects per treatment group) will be enrolled and randomized into the study.

Detailed Description
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This is a Phase 2, multicenter, randomized, double-blind, double-dummy, active-controlled, dose-ranging study of female subjects with moderate to severe Acute Vulvovaginal Candidiasis. Subjects will be randomized to either the investigational arm (SCY-078) with 5 different dose regiments ranging from 1 to 3 days of treatment or to the active-control arm (fluconazole) for 1 day of treatment. After randomization subjects may be seen on study Day 3 (on site visit for PK subjects) , Day 10 (±2,) and Day 25 (+4).

Official Title
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A Phase 2, Multicenter, Randomized, Double-Blind, Double-Dummy, Active-Controlled, Dose-Finding Study to Compare the Safety and Efficacy of Oral Ibrexafungerp (SCY-078) vs. Oral Fluconazole in Subjects With Acute Vulvovaginal Candidiasis

Conditions
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Candida Vulvovaginitis

Intervention / Treatment
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* Drug: Fluconazole
* Drug: SCY-078


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Subject is a female of at least 18 years of age 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) Key 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: 18 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, double-blind, double-dummy, active-controlled, dose-finding
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Fluconazole<br>150 mg/day for 1 day | Drug: Fluconazole<br>* Oral Antifungal comparator<br>* Other names: Diflucan, Azole antifungal;|
| Experimental: Ibrexafungerp 750mg<br>750mg QD for 1 day only | Drug: SCY-078<br>* Investigational Antifungal<br>* Other names: Ibrexafungerp;|
| Experimental: Ibrexafungerp 300mg<br>300mg BID for 1 day only | Drug: SCY-078<br>* Investigational Antifungal<br>* Other names: Ibrexafungerp;|
| Experimental: Ibrexafungerp 450mg<br>450mg BID for 1 day only | Drug: SCY-078<br>* Investigational Antifungal<br>* Other names: Ibrexafungerp;|
| Experimental: Ibrexafungerp 150mg<br>150mg BID for 3 days | Drug: SCY-078<br>* Investigational Antifungal<br>* Other names: Ibrexafungerp;|
| Experimental: Ibrexafungerp 300mg D1-D3<br>300mg BID for 3 days | Drug: SCY-078<br>* Investigational Antifungal<br>* Other names: Ibrexafungerp;|

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 | 8-12 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Co-occurrence of Clinical and Mycological Cure | The percentage of subjects with both clinical cure and mycological eradication (negative fungal culture) the Test-of cure. | 29 days |