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

Scynexis, Inc.186 enrolled

Overview

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.

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

186

Conditions

Candida Vulvovaginitis

Interventions

FluconazoleDRUG

Oral Antifungal comparator

SCY-078DRUG

Investigational Antifungal

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Key Inclusion Criteria: 1. Subject is a female of at least 18 years of age 2. 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: 1. 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) 2. 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 3. Subject is actively menstruating at the time of the Baseline visit. 4. Subject has uncontrolled diabetes mellitus. 5. Subject has a vaginal sample with pH \>4.5. 6. Subject has a history of or an active cervical/vaginal cancer.

Locations (25)

Outcomes

Primary Outcomes

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

Time frame: 8-12 days

Secondary Outcomes

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.

Time frame: 29 days

Data from ClinicalTrials.gov

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