Clinical trial NCT04029116: Phase 3 Study of Oral Ibrexafungerp (SCY-078) Vs. Placebo in Subjects With Recurrent Vulvovaginal Candidiasis (VVC)
Official title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Ibrexafungerp (SCY-078) Compared to Placebo in Subjects With Recurrent Vulvovaginal Candidiasis (VVC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Recurrent Vulvovaginal Candidiasis
Keywords: Recurrent yeast infection
Recurrent yeast vaginitis
Chronic yeast vaginitis
Ibrexafungerp
SCY-078
RVVC
Lead sponsor: Scynexis, Inc.
Sponsor class: INDUSTRY
First posted: 2019-07-23
Enrollment: 440
Sex: FEMALE
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Open label (acute phase treatment) followed by Randomized, Double Blinded phase
Primary purpose: PREVENTION

Brief 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).

Detailed description: This study is a Phase 3, multicenter, randomized, double-blind study to evaluate the efficacy and safety of oral ibrexafungerp (formerly "SCY-078") compared to placebo in female subjects 12 years and older with RVVC. The primary objective of the study is to evaluate the efficacy of oral ibrexafungerp in preventing recurrences of VVC in subjects with RVVC based on Clinical Success. Approximately 320 subjects are planned to be enrolled into the study. All subjects will receive treatment with oral fluconazole for their acute episode present at screening. Subjects who respond to fluconazole for their acute episode will be enrolled in the prevention of recurrence phase of the study and randomized to ibrexafungerp or placebo.

Subjects who fail treatment with fluconazole for their acute episode will be included in a nested open label Sub-Study, in which they will be offered one-day oral ibrexafungerp for their unresolved acute episode.

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.

Primary outcomes:
measure: Clinical Success
timeFrame: Week 24
Secondary outcomes:
measure: The Percentage of Subjects With no Mycologically Proven Recurrence
timeFrame: Week 24
measure: Safety and Tolerability
timeFrame: Week 24
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Precision Trials LLC
state: Arizona
city: San Diego
country: United States
facility: Women's Healthcare Research Corp
state: California
city: Lake Worth
country: United States
facility: Altus Research - Hunt - PPDS
state: Florida
city: Miami
country: United States
facility: New Age Medical Research Corporation
state: Florida
city: North Miami
country: United States
facility: Healthcare Clinical Data Inc
state: Florida
city: Idaho Falls
country: United States
facility: Clinical Research Prime - ClinEdge - PPDS
state: Idaho
city: Covington
country: United States
facility: Clinical Trials Management
state: Louisiana
city: New Orleans
country: United States
facility: Women Under Study, LLC
state: Louisiana
city: Hagerstown
country: United States
facility: Unified Women's Clinical Research
state: Maryland
city: Detroit
country: United States
facility: Wayne State University
state: Michigan
city: Lawrenceville
country: United States
facility: Center For Women's Health and Wellness LLC
state: New Jersey
city: Lawrenceville
country: United States
facility: Lawrence Obstetrics Gynecology Clinical Research LLC
state: New Jersey
city: Albuquerque
country: United States
facility: Bosque Women's Care
state: New Mexico
city: Durham
country: United States
facility: Carolina Women's Research and Wellness Center
state: North Carolina
city: Greensboro
country: United States
facility: Unified Womens CLinical Research
state: North Carolina
city: Raleigh
country: United States
facility: Unified Women's Clinical Research Raleigh
state: North Carolina
city: Raleigh
country: United States
facility: M3 Wake Research, Inc
state: North Carolina
city: Winston-Salem
country: United States
facility: Group For Women
state: North Carolina
city: Winston-Salem
country: United States
facility: Lyndhurst Clinical Research
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Erie
country: United States
facility: Obstetrics and Gynecology Associates of Erie, PC
state: Pennsylvania
city: Philadelphia
country: United States
facility: Jefferson University Hospital
state: Pennsylvania
city: Chattanooga
country: United States
facility: Chattanooga Medical Research Inc
state: Tennessee
city: Memphis
country: United States
facility: Medical Research Center of Memphis, LLC
state: Tennessee
city: Houston
country: United States
facility: TMC Life Research Inc
state: Texas
Study officials:
affiliation: Scynexis, Inc.
name: Nkechi Azie, MD
role: STUDY_DIRECTOR
References: