Efficacy and Safety of Oral Ibrexafungerp (SCY-078) vs. Placebo in Subjects With Acute Vulvovaginal Candidiasis (VANISH 303)
- Registration Number
- NCT03734991
- Lead Sponsor
- Scynexis, Inc.
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 376
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)
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Matching Placebo Ibrexafungerp (SCY-078) Ibrexafungerp 300 mg orally every 12 hrs for 1 day (2 doses in 1 day)
- Primary Outcome Measures
Name Time Method Clinical Cure (Complete Resolution of Signs and Symptoms) Day 8-14 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 Clinical Cure and Mycological Eradication (Responder Outcome) Day 8-14 percentage of subjects with clinical cure and mycological eradication (responder outcome) at the TOC visit
Overall Treatment-Emergent Adverse Events (Safety Set) Up to 29 days Number of subjects with treatment related adverse events
Mycological Eradication (Negative Culture for Growth of Yeast) Day 8-14 percentage of subjects with mycological eradication (negative culture for growth of Candida species) at the TOC visit
Complete Clinical Response at Follow-Up Day 25 percentage of subjects with complete resolution of signs and symptoms at the Follow-up (FU) visit
Trial Locations
- Locations (24)
Women's Medical Research Group
🇺🇸Clearwater, Florida, United States
Unified Women's Clinical Research Greensboro
🇺🇸Greensboro, North Carolina, United States
Magnolia Ob/Gyn Research Center, LLC
🇺🇸Myrtle Beach, South Carolina, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Precision Trials AZ, LLC
🇺🇸Phoenix, Arizona, United States
Womens' Health Care Research Corp
🇺🇸San Diego, California, United States
New Age Medical Research Corporation
🇺🇸Miami, Florida, United States
GYN Center for Women PA
🇺🇸Durham, North Carolina, United States
Carolina Women's Research and Wellness Center
🇺🇸Durham, North Carolina, United States
Altus Research
🇺🇸Lake Worth, Florida, United States
OBGYN Assoc of Mid Florida
🇺🇸Leesburg, Florida, United States
Clinical Trials Management LLC
🇺🇸Metairie, Louisiana, United States
Unified Women's Clinical Research- Hagerstown
🇺🇸Hagerstown, Maryland, United States
Wayne State University
🇺🇸Detroit, Michigan, United States
Lawrence OB/GYN Clinical Research, LLC
🇺🇸Lawrenceville, New Jersey, United States
Consultants In Women's Healthcare, Inc.
🇺🇸Saint Louis, Missouri, United States
Center For Women's Health and Wellness LLC - Interspond - PPDS
🇺🇸Lawrenceville, New Jersey, United States
Unified Women's Clinical Research
🇺🇸Morehead City, North Carolina, United States
Unified Women's Clinical Research - Lyndhurst Clinical Research
🇺🇸Winston-Salem, North Carolina, United States
Unified Women's Clinical Research Raleigh
🇺🇸Raleigh, North Carolina, United States
Medical Research South
🇺🇸Charleston, South Carolina, United States
Medical Research Center of Memphis
🇺🇸Memphis, Tennessee, United States
TMC Life Research Inc
🇺🇸Houston, Texas, United States
Group For Women
🇺🇸Norfolk, Virginia, United States