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

Study Overview
=================
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

Official Title
-----------------
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Oral Ibrexafungerp (SCY-078) vs. Placebo in Subjects With Acute Vulvovaginal Candidiasis (AVVC).

Conditions
-----------------
Candida Vulvovaginitis

Intervention / Treatment
-----------------
* Drug: Ibrexafungerp
* Drug: Placebo


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 12 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, placebo-controlled, double-blind study
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ibrexafungerp (SCY-078)<br>300 mg BID for one day | Drug: Ibrexafungerp<br>* Ibrexafungerp 300mg BID for one day<br>* Other names: SCY-078;|
| Placebo Comparator: Placebo<br>Matching Placebo | Drug: Placebo<br>* Matching Placebo<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vaginitis, Yeast infection