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



Status:Recruiting
Conditions:Women's Studies
Therapuetic Areas:Reproductive
Healthy:No
Age Range:12 - Any
Updated:3/17/2019
Start Date:January 4, 2019
End Date:December 30, 2019
Contact:Rebecca F Cadet
Email:rebecca.cadet@scynexis.com
Phone:201 884-5477

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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

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.

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.

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.
We found this trial at
10
sites
Covington, Louisiana
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4671 S. Congress Ave.
Lake Worth, Florida 33461
561-641-0404
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Lake Worth, FL
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Houston, Texas 77054
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Lawrenceville, New Jersey 08648
Phone: 609-803-2378
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Lawrenceville, NJ
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Metairie, Louisiana 70006
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Metairie, LA
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Miami, FL
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Phoenix, Arizona 85032
Phone: 602-931-4507
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Phoenix, AZ
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3023 North Ballas Road
Saint Louis, Missouri 63131
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Saint Louis, MO
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San Diego, California 92123
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San Diego, CA
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