Efficacy and Safety of Oral Ibrexafungerp (SCY-078) vs. Placebo in Subjects With Acute Vulvovaginal Candidiasis
NCT ID: NCT03987620
Last Updated: 2021-09-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
455 participants
INTERVENTIONAL
2019-06-07
2020-04-29
Brief Summary
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Detailed Description
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* 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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Ibrexafungerp (SCY-078)
300 mg BID for one day
Ibrexafungerp
Ibrexafungerp 300mg BID for one day
Placebo
Matching Placebo
Placebo
Matching Placebo
Interventions
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Ibrexafungerp
Ibrexafungerp 300mg BID for one day
Placebo
Matching Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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)
Exclusion Criteria
* 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.
12 Years
FEMALE
No
Sponsors
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Scynexis, Inc.
INDUSTRY
Responsible Party
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Locations
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Mesa OB-GYN
Mesa, Arizona, United States
Red Rocks OBGYN
Lakewood, Colorado, United States
Planned Parenthood Southern New England
New Haven, Connecticut, United States
New Generation Medical Research
Hialeah, Florida, United States
Healthcare Clinical Data Inc
North Miami, Florida, United States
Physician Care Clinical Research LLC
Sarasota, Florida, United States
CCT LLC - A VitaLink Company- PPDS
West Palm Beach, Florida, United States
Mount Vernon Clinical Research, LLC
Sandy Springs, Georgia, United States
Fellows Research Alliance Inc
Savannah, Georgia, United States
Rosemark Women Care Specialists
Idaho Falls, Idaho, United States
Praetorian Pharmaceutical Research, LLC
Marrero, Louisiana, United States
North County Health Center, Planned Parenthood of the St. Louis Region and Southwest Missouri
Florissant, Missouri, United States
Clinical Research Center Of Nevada
Las Vegas, Nevada, United States
Planned Parenthood North Central Southern New Jersey (PPNCSNJ)
Hackensack, New Jersey, United States
Carolina Institute for Clinical Research - M3 Wake Research
Fayetteville, North Carolina, United States
Obstetrics and Gynecology Associates of Erie, PC
Erie, Pennsylvania, United States
Planned Parenthood Southeastern Pennsylvania The Elizabeth Blackwell Health Center
Philadelphia, Pennsylvania, United States
Fellows Research Alliance Inc
Bluffton, South Carolina, United States
Chattanooga Medical Research Inc
Chattanooga, Tennessee, United States
Signature GYN Services, PLLC
Fort Worth, Texas, United States
Brownstone Clinical Trials, LLC
Irving, Texas, United States
Multiprofile Hospital for Active Treatment -Asenovgrad EOOD
Asenovgrad, , Bulgaria
MHAT Puls AD - PPDS
Blagoevgrad, , Bulgaria
Multiprofile Hospital for Active Treatment - Chirpan EOOD
Chirpan, , Bulgaria
Medical Center Asklepii OOD
Dupnitsa, , Bulgaria
Diagnostic-Consultative Center I-Gabrovo EOOD
Gabrovo, , Bulgaria
Multiprofile Hospital For Active Treatment Dr Tota Venkova
Gabrovo, , Bulgaria
Multiprofile Hospital for Active Treatment Sv. Ivan Rilski - Gorna Oryahovitsa EOOD
Gorna Oryahovitsa, , Bulgaria
Multiprofile Hospital for Active Treatment- Sveti Nikolay Chudotvoretz - LOM EOOD
Lom, , Bulgaria
Multiprofile Hospital for Active Treatment - Prof. Dr. Paraskev Stoyanov AD
Lovech, , Bulgaria
MHAT Stamen Iliev AD
Montana, , Bulgaria
Multiprofile Hospital For Active Treatment - Pazardzhik AD
Pazardzhik, , Bulgaria
Multiprofile Hospital for Active Treatment Trimontsium OOD
Plovdiv, , Bulgaria
Multiprofile Hospital for Active Treatment - Samokov EOOD
Samokov, , Bulgaria
Medical Center-1-Sevlievo EOOD
Sevlievo, , Bulgaria
Multiprofile Hospital for Active Treatment Shumen
Shumen, , Bulgaria
Multiprofile Hospital For Active Treatment - Dr. Bratan Shukerov AD
Smolyan, , Bulgaria
Medical Center Excelsior OOD - PPDS
Sofia, , Bulgaria
Diagnostic Consultative CTR - XX - Sofia - EOOD
Sofia, , Bulgaria
Medical center Vip Clinic OOD
Sofia, , Bulgaria
Medical Center Medica Plus OOD
Veliko Tarnovo, , Bulgaria
Countries
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References
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Goje O, Sobel R, Nyirjesy P, Goldstein SR, Spitzer M, Faught B, Larson S, King T, Azie NE, Angulo D, Sobel JD. Oral Ibrexafungerp for Vulvovaginal Candidiasis Treatment: An Analysis of VANISH 303 and VANISH 306. J Womens Health (Larchmt). 2023 Feb;32(2):178-186. doi: 10.1089/jwh.2022.0132. Epub 2022 Oct 17.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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SCY-078-306
Identifier Type: -
Identifier Source: org_study_id
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