Phase 3 Study of Oral Ibrexafungerp (SCY-078) Vs. Placebo in Subjects With Recurrent Vulvovaginal Candidiasis (VVC)
- Conditions
- Recurrent Vulvovaginal Candidiasis
- Interventions
- Registration Number
- NCT04029116
- Lead Sponsor
- Scynexis, Inc.
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 440
- 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.
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Fluconazole Tablet 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 Placebo Placebo oral tablet 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 Ibrexafungerp Fluconazole Tablet 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 Ibrexafungerp IBREXAFUNGERP 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
- Primary Outcome Measures
Name Time Method Clinical Success Week 24 Efficacy as measured by the percentage of subjects with documented Clinical Success.
- Secondary Outcome Measures
Name Time Method The Percentage of Subjects With no Mycologically Proven Recurrence Week 24 Efficacy as measured by the percentage of subjects with no Mycologically Proven Recurrence
Safety and Tolerability Week 24 Safety as measured by the number of subjects who discontinue due to treatment related adverse events.
Trial Locations
- Locations (25)
Chattanooga Medical Research Inc
🇺🇸Chattanooga, Tennessee, United States
Clinical Research Prime - ClinEdge - PPDS
🇺🇸Idaho Falls, Idaho, United States
Women's Healthcare Research Corp
🇺🇸San Diego, California, United States
Precision Trials LLC
🇺🇸Phoenix, Arizona, United States
Wayne State University
🇺🇸Detroit, Michigan, United States
Carolina Women's Research and Wellness Center
🇺🇸Durham, North Carolina, United States
Altus Research - Hunt - PPDS
🇺🇸Lake Worth, Florida, United States
New Age Medical Research Corporation
🇺🇸Miami, Florida, United States
Healthcare Clinical Data Inc
🇺🇸North Miami, Florida, United States
Women Under Study, LLC
🇺🇸New Orleans, Louisiana, United States
Center For Women's Health and Wellness LLC
🇺🇸Lawrenceville, New Jersey, United States
Bosque Women's Care
🇺🇸Albuquerque, New Mexico, United States
Unified Women's Clinical Research Raleigh
🇺🇸Raleigh, North Carolina, United States
M3 Wake Research, Inc
🇺🇸Raleigh, North Carolina, United States
Lyndhurst Clinical Research
🇺🇸Winston-Salem, North Carolina, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Obstetrics and Gynecology Associates of Erie, PC
🇺🇸Erie, Pennsylvania, United States
Jefferson University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
TMC Life Research Inc
🇺🇸Houston, Texas, United States
Unified Womens CLinical Research
🇺🇸Greensboro, North Carolina, United States
Clinical Trials Management
🇺🇸Covington, Louisiana, United States
Lawrence Obstetrics Gynecology Clinical Research LLC
🇺🇸Lawrenceville, New Jersey, United States
Medical Research Center of Memphis, LLC
🇺🇸Memphis, Tennessee, United States
Unified Women's Clinical Research
🇺🇸Hagerstown, Maryland, United States
Group For Women
🇺🇸Winston-Salem, North Carolina, United States