Efficacy and Safety of Oral Ibrexafungerp (SCY-078) vs. Placebo in Subjects With Acute Vulvovaginal Candidiasis
Vanish 306
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Oral Ibrexafungerp (SCY-078) vs. Placebo in Subjects With Acute Vulvovaginal Candidiasis (AVVC).
1 other identifier
interventional
455
2 countries
41
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jun 2019
Shorter than P25 for phase_3
41 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 7, 2019
CompletedFirst Submitted
Initial submission to the registry
June 12, 2019
CompletedFirst Posted
Study publicly available on registry
June 17, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 29, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 29, 2020
CompletedResults Posted
Study results publicly available
September 8, 2021
CompletedSeptember 8, 2021
August 1, 2021
10 months
June 12, 2019
June 30, 2021
August 11, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clinical Cure (Complete Resolution of Signs and Symptoms)
The percentage of subjects with clinical cure (complete resolution of signs and symptoms) at the test-of-cure (TOC) visit
Day 8-14
Secondary Outcomes (4)
Mycological Eradication (Negative Culture for Growth of Yeast)
Day 8-14
Clinical Cure and Mycological Eradication (Responder Outcome)
Day 8-14
Complete Clinical Response at Follow-up
Day 25
Safety and Tolerability of Ibrexafungerp
Up to 29 Days
Study Arms (2)
Ibrexafungerp (SCY-078)
EXPERIMENTAL300 mg BID for one day
Placebo
PLACEBO COMPARATORMatching Placebo
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Scynexis, Inc.lead
Study Sites (41)
Mesa OB-GYN
Mesa, Arizona, 85209, United States
Red Rocks OBGYN
Lakewood, Colorado, 80228, United States
Planned Parenthood Southern New England
New Haven, Connecticut, 06511, United States
New Generation Medical Research
Hialeah, Florida, 33016, United States
Healthcare Clinical Data Inc
North Miami, Florida, 33161, United States
Physician Care Clinical Research LLC
Sarasota, Florida, 34239, United States
CCT LLC - A VitaLink Company- PPDS
West Palm Beach, Florida, 33409, United States
Mount Vernon Clinical Research, LLC
Sandy Springs, Georgia, 30328, United States
Fellows Research Alliance Inc
Savannah, Georgia, 31406, United States
Rosemark Women Care Specialists
Idaho Falls, Idaho, 83404, United States
Praetorian Pharmaceutical Research, LLC
Marrero, Louisiana, 70072, United States
North County Health Center, Planned Parenthood of the St. Louis Region and Southwest Missouri
Florissant, Missouri, 63033, United States
Clinical Research Center Of Nevada
Las Vegas, Nevada, 89123, United States
Planned Parenthood North Central Southern New Jersey (PPNCSNJ)
Hackensack, New Jersey, 07601, United States
Carolina Institute for Clinical Research - M3 Wake Research
Fayetteville, North Carolina, 28304, United States
Obstetrics and Gynecology Associates of Erie, PC
Erie, Pennsylvania, 16507, United States
Planned Parenthood Southeastern Pennsylvania The Elizabeth Blackwell Health Center
Philadelphia, Pennsylvania, 19107, United States
Fellows Research Alliance Inc
Bluffton, South Carolina, 29910, United States
Chattanooga Medical Research Inc
Chattanooga, Tennessee, 37404, United States
Signature GYN Services, PLLC
Fort Worth, Texas, 76104, United States
Brownstone Clinical Trials, LLC
Irving, Texas, 75062, United States
Multiprofile Hospital for Active Treatment -Asenovgrad EOOD
Asenovgrad, 4230, Bulgaria
MHAT Puls AD - PPDS
Blagoevgrad, 2700, Bulgaria
Multiprofile Hospital for Active Treatment - Chirpan EOOD
Chirpan, 6200, Bulgaria
Medical Center Asklepii OOD
Dupnitsa, 2600, Bulgaria
Diagnostic-Consultative Center I-Gabrovo EOOD
Gabrovo, 5300, Bulgaria
Multiprofile Hospital For Active Treatment Dr Tota Venkova
Gabrovo, 5300, Bulgaria
Multiprofile Hospital for Active Treatment Sv. Ivan Rilski - Gorna Oryahovitsa EOOD
Gorna Oryahovitsa, 5100, Bulgaria
Multiprofile Hospital for Active Treatment- Sveti Nikolay Chudotvoretz - LOM EOOD
Lom, 3600, Bulgaria
Multiprofile Hospital for Active Treatment - Prof. Dr. Paraskev Stoyanov AD
Lovech, 5500, Bulgaria
MHAT Stamen Iliev AD
Montana, 3400, Bulgaria
Multiprofile Hospital For Active Treatment - Pazardzhik AD
Pazardzhik, 4400, Bulgaria
Multiprofile Hospital for Active Treatment Trimontsium OOD
Plovdiv, 4000, Bulgaria
Multiprofile Hospital for Active Treatment - Samokov EOOD
Samokov, 2000, Bulgaria
Medical Center-1-Sevlievo EOOD
Sevlievo, 5400, Bulgaria
Multiprofile Hospital for Active Treatment Shumen
Shumen, 9700, Bulgaria
Multiprofile Hospital For Active Treatment - Dr. Bratan Shukerov AD
Smolyan, 4700, Bulgaria
Medical Center Excelsior OOD - PPDS
Sofia, 1407, Bulgaria
Diagnostic Consultative CTR - XX - Sofia - EOOD
Sofia, 1618, Bulgaria
Medical center Vip Clinic OOD
Sofia, 1680, Bulgaria
Medical Center Medica Plus OOD
Veliko Tarnovo, 5000, Bulgaria
Related Publications (1)
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.
PMID: 36255448DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. David Angulo
- Organization
- SCYNEXIS
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 12, 2019
First Posted
June 17, 2019
Study Start
June 7, 2019
Primary Completion
March 29, 2020
Study Completion
April 29, 2020
Last Updated
September 8, 2021
Results First Posted
September 8, 2021
Record last verified: 2021-08