Efficacy and Safety of Oral Ibrexafungerp (SCY-078) vs. Placebo in Subjects With Acute Vulvovaginal Candidiasis (Vanish 306)

• ClinicalTrials.gov Identifier: NCT03987620
• Recruitment Status: Completed
• First Posted: June 17, 2019
• 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: June 12, 2019
• First Posted Date: June 17, 2019
• 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: June 7, 2019
• Actual Primary Completion Date: March 29, 2020 (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 ]

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: June 12, 2019)

Clinical cure (complete resolution of signs and symptoms) [ Time Frame: Day 8-14 ]

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 ]
  The 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 ]
  The 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 ]
  The percentage of subjects with complete resolution of signs and symptoms at the Follow-up (FU) visit
• Safety and Tolerability of Ibrexafungerp [ Time Frame: Up to 29 Days ]
  Number of subjects with treatment related adverse events

Original Secondary Outcome Measures (submitted: June 12, 2019)

• Mycological eradication (negative culture for growth of yeast) [ Time Frame: Day 8-14 ]
  The 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 ]
  The 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 ]
  The percentage of subjects with complete resolution of symptoms at the Follow-up (FU) visit
• Safety and tolerabillity of Ibrexafungerp [ Time Frame: Up to 29 Days ]
  Number of subjects with treatment related adverse events

• 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
• 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 (AVVC).
• 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 (bis in die) for 1 day
• Oral ibrexafungerp matching placebo BID for 1 day

This is a randomized, double-blind study.

Approximately 366 eligible subjects will be enrolled and randomized in a 2:1 ratio to one of the two study treatment groups. Subjects will be followed for assessments of efficacy and safety for approximately one month after study drug administration. The design of this study is identical to VANISH 303 Study: NCT03734991

• 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: Double (Participant, Investigator)
Primary Purpose: Treatment

• Condition: Candida Vulvovaginitis

Intervention

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

Study Arms

• Experimental: Ibrexafungerp (SCY-078)
  300 mg BID for one day
  Intervention: Drug: Ibrexafungerp
• Placebo Comparator: Placebo
  Matching Placebo
  Intervention: Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 11, 2021): 455
• Original Estimated Enrollment (submitted: June 12, 2019): 366
• Actual Study Completion Date: April 29, 2020
• Actual Primary Completion Date: March 29, 2020 (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% Potassium Hydroxide (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) anti fungal treatment, including prescription or over-the-counter products during the study and treatment for vulvovaginal candidiasis (VVC) 28 days prior to randomization.
• 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: Bulgaria, United States

Administrative Information

• NCT Number: NCT03987620
• Other Study ID Numbers: SCY-078-306
• Has Data Monitoring Committee: Not Provided

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: Not Provided
• Responsible Party: Scynexis, Inc.
• Study Sponsor: Scynexis, Inc.
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Scynexis, Inc.
• Verification Date: August 2021