Dose-Finding Study of Oral Ibrexafungep (SCY-078) vs. Oral Fluconazole in Subjects With Acute Vulvovaginal Candidiasis
DOVE
A Phase 2, Multicenter, Randomized, Double-Blind, Double-Dummy, Active-Controlled, Dose-Finding Study to Compare the Safety and Efficacy of Oral Ibrexafungerp (SCY-078) vs. Oral Fluconazole in Subjects With Acute Vulvovaginal Candidiasis
1 other identifier
interventional
186
1 country
25
Brief Summary
This is a multicenter, randomized, double-blind, double-dummy, active-controlled, dose-finding study to compare the efficacy, safety and tolerability of oral SCY-078 versus oral fluconazole in adult female subjects 18 years and older with moderate to severe Acute Vulvovaginal Candidiasis (AVVC). Approximately 180 eligible subjects (30 subjects per treatment group) will be enrolled and randomized into the study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2017
Shorter than P25 for phase_2
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
July 14, 2017
CompletedStudy Start
First participant enrolled
August 1, 2017
CompletedFirst Posted
Study publicly available on registry
August 17, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 4, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 4, 2018
CompletedResults Posted
Study results publicly available
August 12, 2021
CompletedAugust 12, 2021
August 1, 2021
9 months
July 14, 2017
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
8-12 days
Secondary Outcomes (1)
Co-occurrence of Clinical and Mycological Cure
29 days
Other Outcomes (1)
Incidence of Treatment Emergent Adverse Events
up to 29 days
Study Arms (6)
Fluconazole
ACTIVE COMPARATOR150 mg/day for 1 day
Ibrexafungerp 750mg
EXPERIMENTAL750mg QD for 1 day only
Ibrexafungerp 300mg
EXPERIMENTAL300mg BID for 1 day only
Ibrexafungerp 450mg
EXPERIMENTAL450mg BID for 1 day only
Ibrexafungerp 150mg
EXPERIMENTAL150mg BID for 3 days
Ibrexafungerp 300mg D1-D3
EXPERIMENTAL300mg BID for 3 days
Interventions
Investigational Antifungal
Eligibility Criteria
You may qualify if:
- Subject is a female of at least 18 years of age
- 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)
UAB Personal Health Clinic
Birmingham, Alabama, 35294, United States
Precision Trials AZ, LLC
Phoenix, Arizona, 85032, United States
Women's Health Care Research Corp.
San Diego, California, 92111, United States
Gulf Coast Research Group, LLC
Brandon, Florida, 33510, United States
Altus Research, Inc.
Lake Worth, Florida, 33461, United States
OB-GYN Associates of Mid-Florida P.A.
Leesburg, Florida, 34748, United States
New Age Medical Research Corp.
Miami, Florida, 33186, United States
Visionary Investigators Network
South Miami, Florida, 33160, United States
Atlanta North Gynecology, P.C.
Roswell, Georgia, 30075, United States
Cypress Medical Research Center, LLC
Wichita, Kansas, 67226, United States
Clinical Trials Management, LLC
Covington, Louisiana, 70433, United States
Clinical Trials Management, LLC
Metairie, Louisiana, 70006, United States
Women Under Study, LLC
New Orleans, Louisiana, 70125, United States
Tolan Park Medical Building
Detroit, Michigan, 48201, United States
Consultants in Women's Healthcare, Inc.
St Louis, Missouri, 63131, United States
Lawrence OB/GYN Clinical Research, LLC
Lawrenceville, New Jersey, 08648, United States
Women's Health Research Center
Plainsboro, New Jersey, 08536, United States
Unified Women's Clinical Research - Central Carolina
Greensboro, North Carolina, 27408, United States
Wake Research Associates, LLC
Raleigh, North Carolina, 27612, United States
Drexel University
Philadelphia, Pennsylvania, 19102, United States
Medical Research South, LLC
Charleston, South Carolina, 29407, United States
WR-Medical Research Center of Memphis, LLC
Memphis, Tennessee, 38120, United States
Tmc Life Research, Inc.
Houston, Texas, 77054, United States
Clinical Trials of Texas, Inc.
San Antonio, Texas, 78229, United States
Seattle Women's Health, Research, Gynecology
Seattle, Washington, 98105, United States
Related Publications (1)
Nyirjesy P, Schwebke JR, Angulo DA, Harriott IA, Azie NE, Sobel JD. Phase 2 Randomized Study of Oral Ibrexafungerp Versus Fluconazole in Vulvovaginal Candidiasis. Clin Infect Dis. 2022 Jul 6;74(12):2129-2135. doi: 10.1093/cid/ciab841.
PMID: 34555149DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention 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 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 14, 2017
First Posted
August 17, 2017
Study Start
August 1, 2017
Primary Completion
May 4, 2018
Study Completion
May 4, 2018
Last Updated
August 12, 2021
Results First Posted
August 12, 2021
Record last verified: 2021-08