Ignite Creation Date:
2025-12-24 @ 11:29 PM
Ignite Modification Date:
2025-12-25 @ 9:16 PM
Study NCT ID:
NCT02679456
Status:
COMPLETED
Last Update Posted:
2019-07-12
First Post:
2016-01-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Oral Ibrexafungerp (SCY-078) vs. Oral Fluconazole in Subjects With Vulvovaginal Candidiasis
Sponsor:
Scynexis, Inc.
Organization:
Study Overview
Official Title:
A Multicenter, Randomized, Evaluator Blinded, Active-Controlled Study to Evaluate the Safety and Efficacy of Oral Ibrexafungerp (SCY-078) vs. Oral Fluconazole in Subjects With Vulvovaginal Candidiasis
Status:
COMPLETED
Status Verified Date:
2019-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a randomized, multicenter, evaluator blinded study to evaluate the safety, tolerability, efficacy and pharmacokinetics of SCY-078 compared to Fluconazole in adult patients with moderate to severe Vulvovaginal Candidiasis (VVC) and a history of frequent episodes of VVC. Approximately 90 subjects, meeting the inclusion criteria will be enrolled and randomized in a 1:1:1 ratio to one of the 3 treatment arms: Oral SCY-078 in 2 dose regimens or oral Fluconazole. After enrollment, subjects will be evaluated on Day-5 (end of treatment visit), Day-24 (test of cure visit), Day-60, Day 90 and Day 120 (end of observation period visit) or at any time that a recurrence or clinical failure is suspected, up to the end of observation period.
Detailed Description:
This is a randomized, multicenter, evaluator blinded study to evaluate the safety, tolerability, efficacy and pharmacokinetics of SCY-078 compared to Fluconazole in adult patients, from 18 to 65 years of age, with moderate to severe Vulvovaginal Candidiasis (VVC) and a history of frequent episodes of VVC. Approximately 90 subjects, meeting the inclusion criteria will be enrolled and randomized in a 1:1:1 ratio to one of the 3 treatment arms: oral SCY-078 does regimen 1, or oral SCY-078 does regimen 2, or oral Fluconazole. After enrollment, subjects will be evaluated on Day-5 (end of treatment visit), Day-24 (test of cure visit), Day-60, Day 90 and Day 120 (end of observation period visit) or at any time that a recurrence or clinical failure is suspected, up to the end of observation period.
Primary Objectives:
\* To evaluate the safety and efficacy of 2 dosing regimens of Oral SCY-078 in subjects with moderate to severe Vulvovaginal Candidiasis (VVC)
Secondary Objectives:
\* To estimate the effect of Oral SCY-078 therapy in the rate and time to recurrence in subjects with a history of frequent episodes of VVC
Primary Objectives:
\* To evaluate the safety and efficacy of 2 dosing regimens of Oral SCY-078 in subjects with moderate to severe Vulvovaginal Candidiasis (VVC)
Secondary Objectives:
\* To estimate the effect of Oral SCY-078 therapy in the rate and time to recurrence in subjects with a history of frequent episodes of VVC
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: