Efficacy and Safety of Oral Ibrexafungerp (SCY-078) vs. Placebo in Subjects With Acute Vulvovaginal Candidiasis

Phase 3

Completed

Brief 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.

Detailed 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 (bis in die) for 1 day

* Oral ibrexafungerp matching placebo BID for 1 day

This is a randomized, double-blind study.

Approximately 366 eligible subjects will be enrolled and randomized in a 2:1 ratio to one of the two study treatment groups. Subjects will be followed for assessments of efficacy and safety for approximately one month after study drug administration. The design of this study is identical to VANISH 303 Study: NCT03734991

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Matching Placebo
Ibrexafungerp (SCY-078)	Ibrexafungerp	300 mg BID for one day

Primary Outcome Measures

Name	Time	Method
Clinical Cure (Complete Resolution of Signs and Symptoms)	Day 8-14	The percentage of subjects with clinical cure (complete resolution of signs and symptoms) at the test-of-cure (TOC) visit

Secondary Outcome Measures

Name	Time	Method
Complete Clinical Response at Follow-up	Day 25	The percentage of subjects with complete resolution of signs and symptoms at the Follow-up (FU) visit
Mycological Eradication (Negative Culture for Growth of Yeast)	Day 8-14	The percentage of subjects with mycological eradication (negative culture for growth of Candida species) at the TOC visit
Clinical Cure and Mycological Eradication (Responder Outcome)	Day 8-14	The percentage of subjects with clinical cure and mycological eradication (responder outcome) at the TOC visit
Safety and Tolerability of Ibrexafungerp	Up to 29 Days	Number of subjects with treatment related adverse events

Locations (40): Mesa OB-GYN
🇺🇸
Mesa, Arizona, United States
Red Rocks OBGYN
🇺🇸
Lakewood, Colorado, United States
Planned Parenthood Southern New England
🇺🇸
New Haven, Connecticut, United States
New Generation Medical Research
🇺🇸
Hialeah, Florida, United States
Healthcare Clinical Data Inc
🇺🇸
North Miami, Florida, United States
Physician Care Clinical Research LLC
🇺🇸
Sarasota, Florida, United States
CCT LLC - A VitaLink Company- PPDS
🇺🇸
West Palm Beach, Florida, United States
Mount Vernon Clinical Research, LLC
🇺🇸
Sandy Springs, Georgia, United States
Fellows Research Alliance Inc
🇺🇸
Bluffton, South Carolina, United States
Rosemark Women Care Specialists
🇺🇸
Idaho Falls, Idaho, United States
Scroll for more (30 remaining)
Mesa OB-GYN
🇺🇸Mesa, Arizona, United States