Efficacy and Safety of Oral Ibrexafungerp (SCY-078) vs. Placebo in Subjects With Acute Vulvovaginal Candidiasis (VANISH 303)

Scynexis

Status and phase: Completed; Phase 3

Conditions: Candida Vulvovaginitis

Treatments: Drug: Ibrexafungerp; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03734991

SCY-078-303

Details and patient eligibility

About

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.

Full 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.

Enrollment: 376 patients

Sex: Female

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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376 participants in 2 patient groups, including a placebo group

Ibrexafungerp (SCY-078)

Experimental group

Description:

300 mg orally every 12 hrs for 1 day (2 doses in 1 day)

Treatment:

Drug: Ibrexafungerp

Placebo

Placebo Comparator group

Description:

Matching Placebo

Treatment:

Drug: Placebo