Phase 3
N=455
Efficacy and Safety of Oral Ibrexafungerp (SCY-078) vs. Placebo in Subjects With Acute Vulvovaginal Candidiasis
Candida Vulvovaginitis
Bottom Line
View on ClinicalTrials.gov: NCT03987620 ↗Enrolled (actual)
455
Serious AEs
0.4%
Results posted
Sep 2021
Primary outcome: Primary: Clinical Cure (Complete Resolution of Signs and Symptoms) — 119; 37; 69; 47 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Ibrexafungerp (Drug); Placebo (Drug)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- Female
- Sponsor
- Scynexis, Inc.
- Primary completion
- Mar 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Cure (Complete Resolution of Signs and Symptoms) |
119; 37; 69; 47 | — |
| SECONDARY Mycological Eradication (Negative Culture for Growth of Yeast) |
110; 25; 78; 59 | — |
| SECONDARY Clinical Cure and Mycological Eradication (Responder Outcome) |
82; 23; 96; 58 | — |
| SECONDARY Complete Clinical Response at Follow-up |
137; 44; 52; 45 | — |
| SECONDARY Safety and Tolerability of Ibrexafungerp |
99; 44; 1; 1; 0; 0 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Subject is a postmenarchal female subject 12 years and older
- Subject has a diagnosis of symptomatic AVVC at baseline including a positive microscopic examination with 10% Potassium Hydroxide (KOH) in a vaginal sample revealing yeast forms (hyphae/pseudohyphae) or budding yeasts, and vaginal pH (≤4.5)
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) anti fungal treatment, including prescription or over-the-counter products during the study and treatment for vulvovaginal candidiasis (VVC) 28 days prior to randomization.
- 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.
Data sourced from ClinicalTrials.gov (NCT03987620). 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.