Phase 3 Study of Oral Ibrexafungerp (SCY-078) Vs. Placebo in Subjects With Recurrent Vulvovaginal Candidiasis (VVC)
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).
Timeline
- Start
- 2019-10-21
- Primary completion
- 2021-09-01
- Completion
- 2021-11-29
Outcome
Met primary endpoint
release “statistically significant superiority over placebo for the primary and key secondary study endpoints in the CANDLE Phase 3 trial for recurrent vulvovaginal candidiasis” scynexis.com ↗
release “The CANDLE study met its primary endpoint, with 65.4% of patients with recurrent vulvovaginal candidiasis (RVCC) who received monthly single-day ibrexafungerp treatment achieving clinical success” scynexis.com ↗
release “The CANDLE study met its primary endpoint, with 65.4% of patients who received monthly single-day ibrexafungerp treatment achieving clinical success” scynexis.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ibrexafungerp | Small molecule | 300 mg | Oral |
| Background | Fluconazole | Small molecule | 150 mg | Oral |