Clinical trial NCT03734991: Efficacy and Safety of Oral Ibrexafungerp (SCY-078) vs. Placebo in Subjects With Acute Vulvovaginal Candidiasis (VANISH 303)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Candida Vulvovaginitis
Lead sponsor: Scynexis, Inc.
Sponsor class: INDUSTRY
First posted: 2018-11-08
Enrollment: 376
Sex: FEMALE
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized, placebo-controlled, double-blind study
Primary purpose: TREATMENT

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 for 1 day
* Oral ibrexafungerp matching placebo BID for 1 day

Subjects will receive their first dose of study drug at the site and will be dispensed the second dose for self-administration at home 12 hours after the first dose. Study Blinding, Randomization and Stratification: This is a randomized, double-blind study.

All site and sponsor personnel will be blinded to treatment assignment. Approximately 366 eligible subjects will be enrolled and randomized in a 2:1 ratio to one of the two study treatment groups. For the purpose of maintaining treatment blinding, all subjects randomized to the placebo group will receive matching ibrexafungerp placebo tablets.

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% 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) antifungal treatment, including prescription or over-the-counter products during the study and treatment for VVC 28 days prior to randomization

Subject is actively menstruating at the time of the Baseline visit.

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.

Primary outcomes:
measure: Clinical Cure (Complete Resolution of Signs and Symptoms)
timeFrame: Day 8-14
Secondary outcomes:
measure: Mycological Eradication (Negative Culture for Growth of Yeast)
timeFrame: Day 8-14
measure: Clinical Cure and Mycological Eradication (Responder Outcome)
timeFrame: Day 8-14
measure: Complete Clinical Response at Follow-Up
timeFrame: Day 25
measure: Overall Treatment-Emergent Adverse Events (Safety Set)
timeFrame: Up to 29 days
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Phoenix
country: United States
facility: Precision Trials AZ, LLC
state: Arizona
city: San Diego
country: United States
facility: Womens' Health Care Research Corp
state: California
city: Clearwater
country: United States
facility: Women's Medical Research Group
state: Florida
city: Lake Worth
country: United States
facility: Altus Research
state: Florida
city: Leesburg
country: United States
facility: OBGYN Assoc of Mid Florida
state: Florida
city: Miami
country: United States
facility: New Age Medical Research Corporation
state: Florida
city: Covington
country: United States
facility: Clinical Trials Management LLC
state: Louisiana
city: Metairie
country: United States
facility: Clinical Trials Management LLC
state: Louisiana
city: Hagerstown
country: United States
facility: Unified Women's Clinical Research- Hagerstown
state: Maryland
city: Detroit
country: United States
facility: Wayne State University
state: Michigan
city: Saint Louis
country: United States
facility: Consultants In Women's Healthcare, Inc.
state: Missouri
city: Lawrenceville
country: United States
facility: Center For Women's Health and Wellness LLC - Interspond - PPDS
state: New Jersey
city: Lawrenceville
country: United States
facility: Lawrence OB/GYN Clinical Research, LLC
state: New Jersey
city: Durham
country: United States
facility: GYN Center for Women PA
state: North Carolina
city: Durham
country: United States
facility: Carolina Women's Research and Wellness Center
state: North Carolina
city: Greensboro
country: United States
facility: Unified Women's Clinical Research Greensboro
state: North Carolina
city: Morehead City
country: United States
facility: Unified Women's Clinical Research
state: North Carolina
city: Raleigh
country: United States
facility: Unified Women's Clinical Research Raleigh
state: North Carolina
city: Winston-Salem
country: United States
facility: Unified Women's Clinical Research - Lyndhurst Clinical Research
state: North Carolina
city: Charleston
country: United States
facility: Medical Research South
state: South Carolina
city: Myrtle Beach
country: United States
facility: Magnolia Ob/Gyn Research Center, LLC
state: South Carolina
city: Memphis
country: United States
facility: Medical Research Center of Memphis
state: Tennessee
city: Houston
country: United States
facility: TMC Life Research Inc
state: Texas
city: Norfolk
country: United States
facility: Group For Women
state: Virginia
Study officials:
affiliation: Scynexis, Inc.
name: David Angulo, MD
role: STUDY_DIRECTOR
References:
citation: Goje O, Sobel R, Nyirjesy P, Goldstein SR, Spitzer M, Faught B, Larson S, King T, Azie NE, Angulo D, Sobel JD. Oral Ibrexafungerp for Vulvovaginal Candidiasis Treatment: An Analysis of VANISH 303 and VANISH 306. J Womens Health (Larchmt). 2023 Feb;32(2):178-186. doi: 10.1089/jwh.2022.0132. Epub 2022 Oct 17.