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

• ClinicalTrials.gov Identifier: NCT03734991
• Recruitment Status: Completed
• First Posted: November 8, 2018
• Results First Posted: September 8, 2021
• Last Update Posted: September 8, 2021
• Sponsor: Scynexis, Inc.
• Information provided by (Responsible Party): Scynexis, Inc.

Tracking Information

• First Submitted Date: October 30, 2018
• First Posted Date: November 8, 2018
• Results First Submitted Date: June 30, 2021
• Results First Posted Date: September 8, 2021
• Last Update Posted Date: September 8, 2021
• Actual Study Start Date: January 4, 2019
• Actual Primary Completion Date: August 21, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 30, 2021)

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

Original Primary Outcome Measures (submitted: November 7, 2018)

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

Current Secondary Outcome Measures (submitted: June 30, 2021)

• 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

Original Secondary Outcome Measures (submitted: November 7, 2018)

• 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 resolution of signs and symptoms at follow-up [ Time Frame: Day 25 ]
  percentage of subjects with complete resolution of symptoms at the Follow-up (FU) visit
• Number of subjects with treatment related adverse events [ Time Frame: Up to 29 days ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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.

• Study Type: Interventional
• Study Phase: Phase 3

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

randomized, placebo-controlled, double-blind study

Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment

• Condition: Candida Vulvovaginitis

Intervention

• Drug: Ibrexafungerp
  Ibrexafungerp 300 mg BID for 1 day
  Other Name: SCY-078
• Drug: Placebo
  Matching placebo

Study Arms

• Experimental: Ibrexafungerp (SCY-078)
  300 mg orally every 12 hrs for 1 day (2 doses in 1 day)
  Intervention: Drug: Ibrexafungerp
• Placebo Comparator: Placebo
  Matching Placebo
  Intervention: Drug: Placebo

• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 17, 2019): 376
• Original Estimated Enrollment (submitted: November 7, 2018): 400
• Actual Study Completion Date: September 4, 2019
• Actual Primary Completion Date: August 21, 2019 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes

• Ages: 12 Years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03734991
• Other Study ID Numbers: SCY-078-303
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Scynexis, Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: Scynexis, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: David Angulo, MD; Scynexis, Inc.

• PRS Account: Scynexis, Inc.
• Verification Date: August 2021