Dose-Finding Study of Oral Ibrexafungep (SCY-078) vs. Ora... | NCT03253094 | Trialant
NCT03253094
Sponsor
Scynexis, Inc.
Status
Completed
Last Update Posted
Aug 12, 2021Actual
Enrollment
186Actual
Phase
Phase 2
Conditions
Candida Vulvovaginitis
Interventions
Fluconazole
SCY-078
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT03253094
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
SCY-078-204
Secondary IDs
Not provided
Brief Title
Dose-Finding Study of Oral Ibrexafungep (SCY-078) vs. Oral Fluconazole in Subjects With Acute Vulvovaginal Candidiasis
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
Acronym
DOVE
Organization
Scynexis, Inc.INDUSTRY
Status Module
Record Verification Date
Aug 2021
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Aug 1, 2017Actual
Primary Completion Date
May 4, 2018Actual
Completion Date
May 4, 2018Actual
First Submitted Date
Jul 14, 2017
First Submission Date that Met QC Criteria
Aug 16, 2017
First Posted Date
Aug 17, 2017Actual
Results Waived
Not provided
Results First Submitted Date
Jun 30, 2021
Results First Submitted that Met QC Criteria
Aug 11, 2021
Results First Posted Date
Aug 12, 2021Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Oct 20, 2020
Certification/Extension First Submitted that Passed QC Review
Aug 11, 2021
Certification/Extension First Posted Date
Aug 12, 2021Actual
Last Update Submitted Date
Aug 11, 2021
Last Update Posted Date
Aug 12, 2021Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Scynexis, Inc.INDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
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).
Conditions Module
Conditions
Candida Vulvovaginitis
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
186Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Fluconazole
Active Comparator
150 mg/day for 1 day
Drug: Fluconazole
Ibrexafungerp 750mg
Experimental
750mg QD for 1 day only
Drug: SCY-078
Ibrexafungerp 300mg
Experimental
300mg BID for 1 day only
Drug: SCY-078
Ibrexafungerp 450mg
Experimental
450mg BID for 1 day only
Drug: SCY-078
Ibrexafungerp 150mg
Experimental
150mg BID for 3 days
Drug: SCY-078
Ibrexafungerp 300mg D1-D3
Experimental
300mg BID for 3 days
Drug: SCY-078
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Fluconazole
Drug
Oral Antifungal comparator
Fluconazole
Diflucan, Azole antifungal
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
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
Measure
Description
Time Frame
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.
29 days
Other Outcomes
Measure
Description
Time Frame
Incidence of Treatment Emergent Adverse Events
The number of subjects with treatment related adverse events
up to 29 days
Eligibility Module
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.