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

Phase 2

Completed

• Conditions: Candida Vulvovaginitis
• Interventions: Drug: Fluconazole; Drug: SCY-078

• Registration Number: NCT03253094
• Lead Sponsor: Scynexis, Inc.

Brief Summary

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

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 Timeline

• Study First Submitted: 2017-07-14
• Study Start: 2017-08-01
• Study First Submitted QC: 2017-08-16
• Study First Posted: 2017-08-17
• Primary Completion: 2018-05-04
• Study Completion: 2018-05-04
• Disposition First Submitted: 2020-10-20
• Results First Submitted: 2021-06-30
• Status Verified: 2021-08
• Results First Submitted QC: 2021-08-11
• Disposition First Submitted QC: 2021-08-11
• Last Update Submitted: 2021-08-11
• Results First Posted: 2021-08-12
• Disposition First Posted: 2021-08-12
• Last Update Posted: 2021-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 186

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fluconazole	Fluconazole	150 mg/day for 1 day
Ibrexafungerp 750mg	SCY-078	750mg QD for 1 day only
Ibrexafungerp 450mg	SCY-078	450mg BID for 1 day only
Ibrexafungerp 150mg	SCY-078	150mg BID for 3 days
Ibrexafungerp 300mg D1-D3	SCY-078	300mg BID for 3 days
Ibrexafungerp 300mg	SCY-078	300mg BID for 1 day only

Primary Outcome Measures

Name	Time	Method
Clinical Cure (Complete Resolution of Signs and Symptoms)	8-12 days	Measured by the percentage of subjects with clinical cure (complete resolution of signs and symptoms) at the test-of-cure (TOC) visit

Secondary Outcome Measures

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

Trial Locations

Locations (24)

Drexel University; 🇺🇸 Philadelphia, Pennsylvania, United States

Wake Research Associates, LLC; 🇺🇸 Raleigh, North Carolina, United States

New Age Medical Research Corp.; 🇺🇸 Miami, Florida, United States

Seattle Women's Health, Research, Gynecology; 🇺🇸 Seattle, Washington, United States

Tmc Life Research, Inc.; 🇺🇸 Houston, Texas, United States

Clinical Trials of Texas, Inc.; 🇺🇸 San Antonio, Texas, United States

Gulf Coast Research Group, LLC; 🇺🇸 Brandon, Florida, United States

Atlanta North Gynecology, P.C.; 🇺🇸 Roswell, Georgia, United States

Women's Health Care Research Corp.; 🇺🇸 San Diego, California, United States

OB-GYN Associates of Mid-Florida P.A.; 🇺🇸 Leesburg, Florida, United States

Women Under Study, LLC; 🇺🇸 New Orleans, Louisiana, United States

Tolan Park Medical Building; 🇺🇸 Detroit, Michigan, United States

Unified Women's Clinical Research - Central Carolina; 🇺🇸 Greensboro, North Carolina, United States

Cypress Medical Research Center, LLC; 🇺🇸 Wichita, Kansas, United States

UAB Personal Health Clinic; 🇺🇸 Birmingham, Alabama, United States

Precision Trials AZ, LLC; 🇺🇸 Phoenix, Arizona, United States

Altus Research, Inc.; 🇺🇸 Lake Worth, Florida, United States

Clinical Trials Management, LLC; 🇺🇸 Metairie, Louisiana, United States

Women's Health Research Center; 🇺🇸 Plainsboro, New Jersey, United States

Medical Research South, LLC; 🇺🇸 Charleston, South Carolina, United States

Visionary Investigators Network; 🇺🇸 South Miami, Florida, United States

WR-Medical Research Center of Memphis, LLC; 🇺🇸 Memphis, Tennessee, United States

Consultants in Women's Healthcare, Inc.; 🇺🇸 Saint Louis, Missouri, United States

Lawrence OB/GYN Clinical Research, LLC; 🇺🇸 Lawrenceville, New Jersey, United States