Efficacy and Safety of Oral Ibrexafungerp (SCY-078) vs. Placebo in Subjects With Acute Vulvovaginal Candidiasis (VANISH 303)
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|ClinicalTrials.gov Identifier: NCT03734991|
Recruitment Status : Completed
First Posted : November 8, 2018
Results First Posted : September 8, 2021
Last Update Posted : September 8, 2021
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|Condition or disease||Intervention/treatment||Phase|
|Candida Vulvovaginitis||Drug: Ibrexafungerp Drug: Placebo||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||376 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||randomized, placebo-controlled, double-blind study|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
|Actual Study Start Date :||January 4, 2019|
|Actual Primary Completion Date :||August 21, 2019|
|Actual Study Completion Date :||September 4, 2019|
Experimental: Ibrexafungerp (SCY-078)
300 mg orally every 12 hrs for 1 day (2 doses in 1 day)
Ibrexafungerp 300 mg BID for 1 day
Other Name: SCY-078
Placebo Comparator: Placebo
- Clinical Cure (Complete Resolution of Signs and Symptoms) [ Time Frame: Day 8-14 ]measured by the percentage of subjects with clinical cure (complete resolution of signs and symptoms) at the test-of-cure (TOC) visit
- Mycological Eradication (Negative Culture for Growth of Yeast) [ Time Frame: Day 8-14 ]percentage of subjects with mycological eradication (negative culture for growth of Candida species) at the TOC visit
- Clinical Cure and Mycological Eradication (Responder Outcome) [ Time Frame: Day 8-14 ]percentage of subjects with clinical cure and mycological eradication (responder outcome) at the TOC visit
- Complete Clinical Response at Follow-Up [ Time Frame: Day 25 ]percentage of subjects with complete resolution of signs and symptoms at the Follow-up (FU) visit
- Overall Treatment-Emergent Adverse Events (Safety Set) [ Time Frame: Up to 29 days ]Number of subjects with treatment related adverse events
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|Ages Eligible for Study:||12 Years and older (Child, Adult, Older Adult)|
|Sexes Eligible for Study:||Female|
|Gender Based Eligibility:||Yes|
|Accepts Healthy Volunteers:||No|
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)
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03734991
|Study Director:||David Angulo, MD||Scynexis, Inc.|
Documents provided by Scynexis, Inc.:
|Responsible Party:||Scynexis, Inc.|
|Other Study ID Numbers:||
|First Posted:||November 8, 2018 Key Record Dates|
|Results First Posted:||September 8, 2021|
|Last Update Posted:||September 8, 2021|
|Last Verified:||August 2021|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Bacterial Infections and Mycoses