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

Candida Vulvovaginitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03734991
• Other study ID #: SCY-078-303
• Status: Completed
• Phase: Phase 3
• Start date: January 4, 2019
• Est. completion date: September 4, 2019

Study information

• Verified date: August 2021
• Source: Scynexis, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 376
• Est. completion date: September 4, 2019
• Est. primary completion date: August 21, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 12 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Candida Vulvovaginitis
• Candidiasis
• Candidiasis, Vulvovaginal
• Vulvovaginitis

Intervention

Drug:
• Ibrexafungerp
Ibrexafungerp 300 mg BID for 1 day
• Placebo
Matching placebo

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Medical Research South	Charleston	South Carolina
United States	Women's Medical Research Group	Clearwater	Florida
United States	Clinical Trials Management LLC	Covington	Louisiana
United States	Wayne State University	Detroit	Michigan
United States	Carolina Women's Research and Wellness Center	Durham	North Carolina
United States	GYN Center for Women PA	Durham	North Carolina
United States	Unified Women's Clinical Research Greensboro	Greensboro	North Carolina
United States	Unified Women's Clinical Research- Hagerstown	Hagerstown	Maryland
United States	TMC Life Research Inc	Houston	Texas
United States	Altus Research	Lake Worth	Florida
United States	Center For Women's Health and Wellness LLC - Interspond - PPDS	Lawrenceville	New Jersey
United States	Lawrence OB/GYN Clinical Research, LLC	Lawrenceville	New Jersey
United States	OBGYN Assoc of Mid Florida	Leesburg	Florida
United States	Medical Research Center of Memphis	Memphis	Tennessee
United States	Clinical Trials Management LLC	Metairie	Louisiana
United States	New Age Medical Research Corporation	Miami	Florida
United States	Unified Women's Clinical Research	Morehead City	North Carolina
United States	Magnolia Ob/Gyn Research Center, LLC	Myrtle Beach	South Carolina
United States	Group For Women	Norfolk	Virginia
United States	Precision Trials AZ, LLC	Phoenix	Arizona
United States	Unified Women's Clinical Research Raleigh	Raleigh	North Carolina
United States	Consultants In Women's Healthcare, Inc.	Saint Louis	Missouri
United States	Womens' Health Care Research Corp	San Diego	California
United States	Unified Women's Clinical Research - Lyndhurst Clinical Research	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Scynexis, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Cure (Complete Resolution of Signs and Symptoms)	measured by the percentage of subjects with clinical cure (complete resolution of signs and symptoms) at the test-of-cure (TOC) visit	Day 8-14
Secondary	Mycological Eradication (Negative Culture for Growth of Yeast)	percentage of subjects with mycological eradication (negative culture for growth of Candida species) at the TOC visit	Day 8-14
Secondary	Clinical Cure and Mycological Eradication (Responder Outcome)	percentage of subjects with clinical cure and mycological eradication (responder outcome) at the TOC visit	Day 8-14
Secondary	Complete Clinical Response at Follow-Up	percentage of subjects with complete resolution of signs and symptoms at the Follow-up (FU) visit	Day 25
Secondary	Overall Treatment-Emergent Adverse Events (Safety Set)	Number of subjects with treatment related adverse events	Up to 29 days