Efficacy and Safety of Oral Ibrexafungerp (SCY-078) vs. Placebo in Subjects With Acute Vulvovaginal Candidiasis
- Registration Number
- NCT03987620
- 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 (bis in die) for 1 day
* Oral ibrexafungerp matching placebo BID for 1 day
This is a randomized, double-blind study.
Approximately 366 eligible subjects will be enrolled and randomized in a 2:1 ratio to one of the two study treatment groups. Subjects will be followed for assessments of efficacy and safety for approximately one month after study drug administration. The design of this study is identical to VANISH 303 Study: NCT03734991
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 455
- 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% Potassium Hydroxide (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) anti fungal treatment, including prescription or over-the-counter products during the study and treatment for vulvovaginal candidiasis (VVC) 28 days prior to randomization.
- 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 BID for one day
- Primary Outcome Measures
Name Time Method Clinical Cure (Complete Resolution of Signs and Symptoms) Day 8-14 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 Complete Clinical Response at Follow-up Day 25 The percentage of subjects with complete resolution of signs and symptoms at the Follow-up (FU) visit
Mycological Eradication (Negative Culture for Growth of Yeast) Day 8-14 The percentage of subjects with mycological eradication (negative culture for growth of Candida species) at the TOC visit
Clinical Cure and Mycological Eradication (Responder Outcome) Day 8-14 The percentage of subjects with clinical cure and mycological eradication (responder outcome) at the TOC visit
Safety and Tolerability of Ibrexafungerp Up to 29 Days Number of subjects with treatment related adverse events
Trial Locations
- Locations (40)
New Generation Medical Research
🇺🇸Hialeah, Florida, United States
Physician Care Clinical Research LLC
🇺🇸Sarasota, Florida, United States
Planned Parenthood Southeastern Pennsylvania The Elizabeth Blackwell Health Center
🇺🇸Philadelphia, Pennsylvania, United States
Chattanooga Medical Research Inc
🇺🇸Chattanooga, Tennessee, United States
Multiprofile Hospital for Active Treatment - Chirpan EOOD
🇧🇬Chirpan, Bulgaria
Multiprofile Hospital for Active Treatment Sv. Ivan Rilski - Gorna Oryahovitsa EOOD
🇧🇬Gorna Oryahovitsa, Bulgaria
Medical center Vip Clinic OOD
🇧🇬Sofia, Bulgaria
Fellows Research Alliance Inc
🇺🇸Bluffton, South Carolina, United States
Rosemark Women Care Specialists
🇺🇸Idaho Falls, Idaho, United States
Planned Parenthood North Central Southern New Jersey (PPNCSNJ)
🇺🇸Hackensack, New Jersey, United States
Healthcare Clinical Data Inc
🇺🇸North Miami, Florida, United States
Praetorian Pharmaceutical Research, LLC
🇺🇸Marrero, Louisiana, United States
Diagnostic-Consultative Center I-Gabrovo EOOD
🇧🇬Gabrovo, Bulgaria
MHAT Puls AD - PPDS
🇧🇬Blagoevgrad, Bulgaria
Brownstone Clinical Trials, LLC
🇺🇸Irving, Texas, United States
Mount Vernon Clinical Research, LLC
🇺🇸Sandy Springs, Georgia, United States
Clinical Research Center Of Nevada
🇺🇸Las Vegas, Nevada, United States
Multiprofile Hospital For Active Treatment Dr Tota Venkova
🇧🇬Gabrovo, Bulgaria
MHAT Stamen Iliev AD
🇧🇬Montana, Bulgaria
Multiprofile Hospital For Active Treatment - Dr. Bratan Shukerov AD
🇧🇬Smolyan, Bulgaria
Multiprofile Hospital for Active Treatment Trimontsium OOD
🇧🇬Plovdiv, Bulgaria
Medical Center-1-Sevlievo EOOD
🇧🇬Sevlievo, Bulgaria
Multiprofile Hospital for Active Treatment Shumen
🇧🇬Shumen, Bulgaria
Multiprofile Hospital for Active Treatment - Prof. Dr. Paraskev Stoyanov AD
🇧🇬Lovech, Bulgaria
Multiprofile Hospital for Active Treatment - Samokov EOOD
🇧🇬Samokov, Bulgaria
Multiprofile Hospital for Active Treatment -Asenovgrad EOOD
🇧🇬Asenovgrad, Bulgaria
Medical Center Asklepii OOD
🇧🇬Dupnitsa, Bulgaria
Multiprofile Hospital For Active Treatment - Pazardzhik AD
🇧🇬Pazardzhik, Bulgaria
Medical Center Excelsior OOD - PPDS
🇧🇬Sofia, Bulgaria
Diagnostic Consultative CTR - XX - Sofia - EOOD
🇧🇬Sofia, Bulgaria
Red Rocks OBGYN
🇺🇸Lakewood, Colorado, United States
Mesa OB-GYN
🇺🇸Mesa, Arizona, United States
CCT LLC - A VitaLink Company- PPDS
🇺🇸West Palm Beach, Florida, United States
Carolina Institute for Clinical Research - M3 Wake Research
🇺🇸Fayetteville, North Carolina, United States
North County Health Center, Planned Parenthood of the St. Louis Region and Southwest Missouri
🇺🇸Florissant, Missouri, United States
Obstetrics and Gynecology Associates of Erie, PC
🇺🇸Erie, Pennsylvania, United States
Signature GYN Services, PLLC
🇺🇸Fort Worth, Texas, United States
Multiprofile Hospital for Active Treatment- Sveti Nikolay Chudotvoretz - LOM EOOD
🇧🇬Lom, Bulgaria
Medical Center Medica Plus OOD
🇧🇬Veliko Tarnovo, Bulgaria
Planned Parenthood Southern New England
🇺🇸New Haven, Connecticut, United States