Phase 3
N=260
Phase 3 Study of Oral Ibrexafungerp (SCY-078) Vs. Placebo in Subjects With Recurrent Vulvovaginal Candidiasis (VVC)
Recurrent Vulvovaginal Candidiasis
Bottom Line
View on ClinicalTrials.gov: NCT04029116 ↗Enrolled (actual)
260
Serious AEs
0.4%
Results posted
Jun 2023
Primary outcome: Primary: Clinical Success — 85; 69; 45; 61 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Fluconazole Tablet (Drug); IBREXAFUNGERP (Drug); Placebo oral tablet (Drug)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- Female
- Sponsor
- Scynexis, Inc.
- Primary completion
- Sep 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Success |
85; 69; 45; 61 | — |
| SECONDARY The Percentage of Subjects With no Mycologically Proven Recurrence |
92; 76; 38; 54 | — |
| SECONDARY Safety and Tolerability |
0; 1 | — |
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).
Eligibility Criteria
Key Inclusion Criteria
- Diagnosis of symptomatic VVC with microscopic examination with KOH positive for yeast and normal vaginal pH.
- History of 3 or more episodes of VVC in the past 12 months.
- Culture confirmation and resolution of the signs and symptoms of the initial VVC episode (with treatment).
- Able to take oral tablets and capsules.
Key exclusion Criteria
- Vaginal conditions other than recurrent VVC that may interfere with the diagnosis or evaluation of response to therapy.
- Recent use of systemic and/or topical vaginal antifungal products.
- Pregnant.
- History of major system organ disease.
Data sourced from ClinicalTrials.gov (NCT04029116). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.