Back to resultsDose-Finding Study of Oral Ibrexafungep (SCY-078) vs. Oral Fluconazole in Subjects With Acute Vulvovaginal Candidiasis (DOVE)
Primary Purpose
Candida Vulvovaginitis
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Fluconazole
SCY-078
Sponsored by
About this trial
This is an interventional treatment trial for Candida Vulvovaginitis
Eligibility Criteria
Key Inclusion Criteria:
- 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)
Key Exclusion Criteria:
- 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.
Sites / Locations
- UAB Personal Health Clinic
- Precision Trials AZ, LLC
- Women's Health Care Research Corp.
- Gulf Coast Research Group, LLC
- Altus Research, Inc.
- OB-GYN Associates of Mid-Florida P.A.
- New Age Medical Research Corp.
- Visionary Investigators Network
- Atlanta North Gynecology, P.C.
- Cypress Medical Research Center, LLC
- Clinical Trials Management, LLC
- Clinical Trials Management, LLC
- Women Under Study, LLC
- Tolan Park Medical Building
- Consultants in Women's Healthcare, Inc.
- Lawrence OB/GYN Clinical Research, LLC
- Women's Health Research Center
- Unified Women's Clinical Research - Central Carolina
- Wake Research Associates, LLC
- Drexel University
- Medical Research South, LLC
- WR-Medical Research Center of Memphis, LLC
- Tmc Life Research, Inc.
- Clinical Trials of Texas, Inc.
- Seattle Women's Health, Research, Gynecology
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Active Comparator
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Fluconazole
Ibrexafungerp 750mg
Ibrexafungerp 300mg
Ibrexafungerp 450mg
Ibrexafungerp 150mg
Ibrexafungerp 300mg D1-D3
Arm Description
150 mg/day for 1 day
750mg QD for 1 day only
300mg BID for 1 day only
450mg BID for 1 day only
150mg BID for 3 days
300mg BID for 3 days
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Co-occurrence of Clinical and Mycological Cure
The percentage of subjects with both clinical cure and mycological eradication (negative fungal culture) the Test-of cure.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03253094
Brief Title
Dose-Finding Study of Oral Ibrexafungep (SCY-078) vs. Oral Fluconazole in Subjects With Acute Vulvovaginal Candidiasis
Acronym
DOVE
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
May 4, 2018 (Actual)
Study Completion Date
May 4, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Scynexis, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
This is a Phase 2, multicenter, randomized, double-blind, double-dummy, active-controlled, dose-ranging study of female subjects with moderate to severe Acute Vulvovaginal Candidiasis. Subjects will be randomized to either the investigational arm (SCY-078) with 5 different dose regiments ranging from 1 to 3 days of treatment or to the active-control arm (fluconazole) for 1 day of treatment. After randomization subjects may be seen on study Day 3 (on site visit for PK subjects) , Day 10 (±2,) and Day 25 (+4).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Candida Vulvovaginitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
randomized, double-blind, double-dummy, active-controlled, dose-finding
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
186 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fluconazole
Arm Type
Active Comparator
Arm Description
150 mg/day for 1 day
Arm Title
Ibrexafungerp 750mg
Arm Type
Experimental
Arm Description
750mg QD for 1 day only
Arm Title
Ibrexafungerp 300mg
Arm Type
Experimental
Arm Description
300mg BID for 1 day only
Arm Title
Ibrexafungerp 450mg
Arm Type
Experimental
Arm Description
450mg BID for 1 day only
Arm Title
Ibrexafungerp 150mg
Arm Type
Experimental
Arm Description
150mg BID for 3 days
Arm Title
Ibrexafungerp 300mg D1-D3
Arm Type
Experimental
Arm Description
300mg BID for 3 days
Intervention Type
Drug
Intervention Name(s)
Fluconazole
Other Intervention Name(s)
Diflucan, Azole antifungal
Intervention Description
Oral Antifungal comparator
Intervention Type
Drug
Intervention Name(s)
SCY-078
Other Intervention Name(s)
Ibrexafungerp
Intervention Description
Investigational Antifungal
Primary Outcome Measure Information:
Title
Clinical Cure (Complete Resolution of Signs and Symptoms)
Description
Measured by the percentage of subjects with clinical cure (complete resolution of signs and symptoms) at the test-of-cure (TOC) visit
Time Frame
8-12 days
Secondary Outcome Measure Information:
Title
Co-occurrence of Clinical and Mycological Cure
Description
The percentage of subjects with both clinical cure and mycological eradication (negative fungal culture) the Test-of cure.
Time Frame
29 days
Other Pre-specified Outcome Measures:
Title
Incidence of Treatment Emergent Adverse Events
Description
The number of subjects with treatment related adverse events
Time Frame
up to 29 days
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
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)
Key Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Angulo, MD
Organizational Affiliation
Scynexis, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
UAB Personal Health Clinic
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Precision Trials AZ, LLC
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
Women's Health Care Research Corp.
City
San Diego
State/Province
California
ZIP/Postal Code
92111
Country
United States
Facility Name
Gulf Coast Research Group, LLC
City
Brandon
State/Province
Florida
ZIP/Postal Code
33510
Country
United States
Facility Name
Altus Research, Inc.
City
Lake Worth
State/Province
Florida
ZIP/Postal Code
33461
Country
United States
Facility Name
OB-GYN Associates of Mid-Florida P.A.
City
Leesburg
State/Province
Florida
ZIP/Postal Code
34748
Country
United States
Facility Name
New Age Medical Research Corp.
City
Miami
State/Province
Florida
ZIP/Postal Code
33186
Country
United States
Facility Name
Visionary Investigators Network
City
South Miami
State/Province
Florida
ZIP/Postal Code
33160
Country
United States
Facility Name
Atlanta North Gynecology, P.C.
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30075
Country
United States
Facility Name
Cypress Medical Research Center, LLC
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67226
Country
United States
Facility Name
Clinical Trials Management, LLC
City
Covington
State/Province
Louisiana
ZIP/Postal Code
70433
Country
United States
Facility Name
Clinical Trials Management, LLC
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Women Under Study, LLC
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70125
Country
United States
Facility Name
Tolan Park Medical Building
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Consultants in Women's Healthcare, Inc.
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63131
Country
United States
Facility Name
Lawrence OB/GYN Clinical Research, LLC
City
Lawrenceville
State/Province
New Jersey
ZIP/Postal Code
08648
Country
United States
Facility Name
Women's Health Research Center
City
Plainsboro
State/Province
New Jersey
ZIP/Postal Code
08536
Country
United States
Facility Name
Unified Women's Clinical Research - Central Carolina
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27408
Country
United States
Facility Name
Wake Research Associates, LLC
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Drexel University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19102
Country
United States
Facility Name
Medical Research South, LLC
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29407
Country
United States
Facility Name
WR-Medical Research Center of Memphis, LLC
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
Tmc Life Research, Inc.
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
Facility Name
Clinical Trials of Texas, Inc.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Seattle Women's Health, Research, Gynecology
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
34555149
Citation
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.
Results Reference
derived
Learn more about this trial
Dose-Finding Study of Oral Ibrexafungep (SCY-078) vs. Oral Fluconazole in Subjects With Acute Vulvovaginal Candidiasis
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