Efficacy and Safety of Oral Ibrexafungerp (SCY-078) vs. Placebo in Subjects With Acute Vulvovaginal Candidiasis (VANISH 303)
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
1 other identifier
interventional
376
1 country
25
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 Jan 2019
Shorter than P25 for phase_3
25 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
First Submitted
Initial submission to the registry
October 30, 2018
CompletedFirst Posted
Study publicly available on registry
November 8, 2018
CompletedStudy Start
First participant enrolled
January 4, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 21, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 4, 2019
CompletedResults Posted
Study results publicly available
September 8, 2021
CompletedSeptember 8, 2021
August 1, 2021
8 months
October 30, 2018
June 30, 2021
August 11, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Clinical Cure (Complete Resolution of Signs and Symptoms)
measured by 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
Overall Treatment-Emergent Adverse Events (Safety Set)
Up to 29 days
Study Arms (2)
Ibrexafungerp (SCY-078)
EXPERIMENTAL300 mg orally every 12 hrs for 1 day (2 doses in 1 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% 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) 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Scynexis, Inc.lead
Study Sites (25)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Precision Trials AZ, LLC
Phoenix, Arizona, 85032, United States
Womens' Health Care Research Corp
San Diego, California, 92111, United States
Women's Medical Research Group
Clearwater, Florida, 33759, United States
Altus Research
Lake Worth, Florida, 33461, United States
OBGYN Assoc of Mid Florida
Leesburg, Florida, 34748, United States
New Age Medical Research Corporation
Miami, Florida, 33186, United States
Clinical Trials Management LLC
Covington, Louisiana, 70006, United States
Clinical Trials Management LLC
Metairie, Louisiana, 70006, United States
Unified Women's Clinical Research- Hagerstown
Hagerstown, Maryland, 21740, United States
Wayne State University
Detroit, Michigan, 48201, United States
Consultants In Women's Healthcare, Inc.
St Louis, Missouri, 63131, United States
Center For Women's Health and Wellness LLC - Interspond - PPDS
Lawrenceville, New Jersey, 08648, United States
Lawrence OB/GYN Clinical Research, LLC
Lawrenceville, New Jersey, 08648, United States
GYN Center for Women PA
Durham, North Carolina, 27612, United States
Carolina Women's Research and Wellness Center
Durham, North Carolina, 27713, United States
Unified Women's Clinical Research Greensboro
Greensboro, North Carolina, 27408, United States
Unified Women's Clinical Research
Morehead City, North Carolina, 28557, United States
Unified Women's Clinical Research Raleigh
Raleigh, North Carolina, 27607, United States
Unified Women's Clinical Research - Lyndhurst Clinical Research
Winston-Salem, North Carolina, 27103, United States
Medical Research South
Charleston, South Carolina, 29414, United States
Magnolia Ob/Gyn Research Center, LLC
Myrtle Beach, South Carolina, 29572, United States
Medical Research Center of Memphis
Memphis, Tennessee, 38120, United States
TMC Life Research Inc
Houston, Texas, 77054, United States
Group For Women
Norfolk, Virginia, 23502, United States
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
Study Officials
- STUDY DIRECTOR
David Angulo, MD
Scynexis, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 30, 2018
First Posted
November 8, 2018
Study Start
January 4, 2019
Primary Completion
August 21, 2019
Study Completion
September 4, 2019
Last Updated
September 8, 2021
Results First Posted
September 8, 2021
Record last verified: 2021-08
Data Sharing
- IPD Sharing
- Will not share