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Clinical Trial Summary

This is a Phase 3, randomized, multicenter, double-blind, placebo-controlled study to evaluate the efficacy and safety of oral Ibrexafungerp (SCY-078) compared to placebo in female subjects 12 years and older with AVVC.


Clinical Trial Description

Subjects who meet all of the inclusion and none of the exclusion criteria will be enrolled into the study and will be randomized in a 2:1 ratio to either oral ibrexafungerp or ibrexafungerp matching placebo, as follows: - Oral ibrexafungerp 300-mg dose BID for 1 day - Oral ibrexafungerp matching placebo BID for 1 day Subjects will receive their first dose of study drug at the site and will be dispensed the second dose for self-administration at home 12 hours after the first dose. Study Blinding, Randomization and Stratification: This is a randomized, double-blind study. All site and sponsor personnel will be blinded to treatment assignment. Approximately 366 eligible subjects will be enrolled and randomized in a 2:1 ratio to one of the two study treatment groups. For the purpose of maintaining treatment blinding, all subjects randomized to the placebo group will receive matching ibrexafungerp placebo tablets. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03734991
Study type Interventional
Source Scynexis, Inc.
Contact
Status Completed
Phase Phase 3
Start date January 4, 2019
Completion date September 4, 2019

See also
  Status Clinical Trial Phase
Completed NCT03987620 - Efficacy and Safety of Oral Ibrexafungerp (SCY-078) vs. Placebo in Subjects With Acute Vulvovaginal Candidiasis Phase 3
Recruiting NCT04219605 - Evaluation of a Rapid Microscopic Diagnostic System for Different Vaginitis Conditions
Completed NCT03253094 - Dose-Finding Study of Oral Ibrexafungep (SCY-078) vs. Oral Fluconazole in Subjects With Acute Vulvovaginal Candidiasis Phase 2