Phase 3 Study of Oral Ibrexafungerp (SCY-078) Vs. Placebo in Subjects With Recurrent Vulvovaginal Candidiasis (VVC)
CANDLE
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Ibrexafungerp (SCY-078) Compared to Placebo in Subjects With Recurrent Vulvovaginal Candidiasis (VVC)
1 other identifier
interventional
440
1 country
25
Brief Summary
This study is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of oral ibrexafungerp (formerly "SCY-078") compared to placebo in female subjects 12 years and older with recurrent VVC (RVVC).
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 Oct 2019
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 19, 2019
CompletedFirst Posted
Study publicly available on registry
July 23, 2019
CompletedStudy Start
First participant enrolled
October 21, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
November 29, 2021
CompletedResults Posted
Study results publicly available
June 18, 2023
CompletedJune 18, 2023
May 1, 2023
1.9 years
July 19, 2019
February 8, 2023
May 25, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clinical Success
Efficacy as measured by the percentage of subjects with documented Clinical Success.
Week 24
Secondary Outcomes (2)
The Percentage of Subjects With no Mycologically Proven Recurrence
Week 24
Safety and Tolerability
Week 24
Study Arms (2)
Ibrexafungerp
EXPERIMENTALOral Fluconazole 150 mg every 72 hours for 3 doses followed by Oral Ibrexafungerp 300 mg BID (one day) every 4 weeks for a total of 6 dosing days
Placebo
PLACEBO COMPARATOROral Fluconazole 150 mg every 72 hours for 3 doses followed by Oral Placebo BID (one day) every 4 weeks for a total of 6 dosing days
Interventions
300 mg BID (one day) every 4 weeks for a total of 6 dosing days
Eligibility Criteria
You may qualify if:
- Diagnosis of symptomatic VVC with microscopic examination with KOH positive for yeast and normal vaginal pH.
- History of 3 or more episodes of VVC in the past 12 months.
- Culture confirmation and resolution of the signs and symptoms of the initial VVC episode (with treatment).
- Able to take oral tablets and capsules.
You may not qualify if:
- Vaginal conditions other than recurrent VVC that may interfere with the diagnosis or evaluation of response to therapy.
- Recent use of systemic and/or topical vaginal antifungal products.
- Pregnant.
- History of major system organ disease.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Scynexis, Inc.lead
Study Sites (25)
Precision Trials LLC
Phoenix, Arizona, 85032, United States
Women's Healthcare Research Corp
San Diego, California, 92111, United States
Altus Research - Hunt - PPDS
Lake Worth, Florida, 33461, United States
New Age Medical Research Corporation
Miami, Florida, 33186, United States
Healthcare Clinical Data Inc
North Miami, Florida, 33161, United States
Clinical Research Prime - ClinEdge - PPDS
Idaho Falls, Idaho, 83404, United States
Clinical Trials Management
Covington, Louisiana, 70433, United States
Women Under Study, LLC
New Orleans, Louisiana, 70125, United States
Unified Women's Clinical Research
Hagerstown, Maryland, 21740, United States
Wayne State University
Detroit, Michigan, 48201, United States
Center For Women's Health and Wellness LLC
Lawrenceville, New Jersey, 08648, United States
Lawrence Obstetrics Gynecology Clinical Research LLC
Lawrenceville, New Jersey, 08648, United States
Bosque Women's Care
Albuquerque, New Mexico, 87109, United States
Carolina Women's Research and Wellness Center
Durham, North Carolina, 27713, United States
Unified Womens CLinical Research
Greensboro, North Carolina, 27408, United States
Unified Women's Clinical Research Raleigh
Raleigh, North Carolina, 27607, United States
M3 Wake Research, Inc
Raleigh, North Carolina, 27612, United States
Group For Women
Winston-Salem, North Carolina, 27103, United States
Lyndhurst Clinical Research
Winston-Salem, North Carolina, 27103, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Obstetrics and Gynecology Associates of Erie, PC
Erie, Pennsylvania, 16507, United States
Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
Chattanooga Medical Research Inc
Chattanooga, Tennessee, 37404, United States
Medical Research Center of Memphis, LLC
Memphis, Tennessee, 38120, United States
TMC Life Research Inc
Houston, Texas, 77054, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. David Angulo
- Organization
- SCYNEXIS
Study Officials
- STUDY DIRECTOR
Nkechi Azie, 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, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 19, 2019
First Posted
July 23, 2019
Study Start
October 21, 2019
Primary Completion
September 1, 2021
Study Completion
November 29, 2021
Last Updated
June 18, 2023
Results First Posted
June 18, 2023
Record last verified: 2023-05