Phase 3 Study of Oral Ibrexafungerp (SCY-078) Vs. Placebo in Subjects With Recurrent Vulvovaginal Candidiasis (VVC) (CANDLE)

• ClinicalTrials.gov Identifier: NCT04029116
• Recruitment Status: Completed
• First Posted: July 23, 2019
• Last Update Posted: April 18, 2022
• Sponsor: Scynexis, Inc.
• Information provided by (Responsible Party): Scynexis, Inc.

Tracking Information

• First Submitted Date: July 19, 2019
• First Posted Date: July 23, 2019
• Last Update Posted Date: April 18, 2022
• Actual Study Start Date: October 21, 2019
• Actual Primary Completion Date: September 1, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 22, 2019)

Clinical Success [ Time Frame: Week 24 ]

Efficacy as measured by the percentage of subjects with documented Clinical Success.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: July 22, 2019)

• The percentage of subjects with no Mycologically Proven Recurrence [ Time Frame: Week 24 and Week 36 ]
  Efficacy as measured by the percentage of subjects with no Mycologically Proven Recurrence
• Safety and tolerability [ Time Frame: Week 24 ]
  Safety as measured by the number of subjects who discontinue due to treatment related adverse events.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Phase 3 Study of Oral Ibrexafungerp (SCY-078) Vs. Placebo in Subjects With Recurrent Vulvovaginal Candidiasis (VVC)
• Official Title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Ibrexafungerp (SCY-078) Compared to Placebo in Subjects With Recurrent Vulvovaginal Candidiasis (VVC)
• Brief Summary: This study is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of oral ibrexafungerp (formerly "SCY-078") compared to placebo in female subjects 12 years and older with recurrent VVC (RVVC).

Detailed Description

This study is a Phase 3, multicenter, randomized, double-blind study to evaluate the efficacy and safety of oral ibrexafungerp (formerly "SCY-078") compared to placebo in female subjects 12 years and older with RVVC. The primary objective of the study is to evaluate the efficacy of oral ibrexafungerp in preventing recurrences of VVC in subjects with RVVC based on Clinical Success. Approximately 320 subjects are planned to be enrolled into the study. All subjects will receive treatment with oral fluconazole for their acute episode present at screening. Subjects who respond to fluconazole for their acute episode will be enrolled in the prevention of recurrence phase of the study and randomized to ibrexafungerp or placebo.

Subjects who fail treatment with fluconazole for their acute episode will be included in a nested open label Sub-Study, in which they will be offered one-day oral ibrexafungerp for their unresolved acute episode.

• Study Type: Interventional
• Study Phase: Phase 3

Study Design

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

Open label (acute phase treatment) followed by Randomized, Double Blinded phase

Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention

• Condition: Recurrent Vulvovaginal Candidiasis

Intervention

• Drug: Fluconazole Tablet
  150 mg every 72 hours for 3 doses
• Drug: IBREXAFUNGERP
  300 mg BID (one day) every 4 weeks for a total of 6 dosing days
  Other Name: SCY-078
• Drug: Placebo oral tablet
  BID (one day) every 4 weeks for a total of 6 dosing days

Study Arms

• Experimental: Ibrexafungerp
  Oral Fluconazole 150 mg every 72 hours for 3 doses followed by Oral Ibrexafungerp 300 mg BID (one day) every 4 weeks for a total of 6 dosing days
  Interventions:

  • Drug: Fluconazole Tablet
  • Drug: IBREXAFUNGERP
• Placebo Comparator: Placebo
  Oral Fluconazole 150 mg every 72 hours for 3 doses followed by Oral Placebo BID (one day) every 4 weeks for a total of 6 dosing days
  Interventions:

  • Drug: Fluconazole Tablet
  • Drug: Placebo oral tablet

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 15, 2022): 440
• Original Estimated Enrollment (submitted: July 22, 2019): 320
• Actual Study Completion Date: November 29, 2021
• Actual Primary Completion Date: September 1, 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria

Key Inclusion Criteria:

• Diagnosis of symptomatic VVC with microscopic examination with KOH positive for yeast and normal vaginal pH.
• History of 3 or more episodes of VVC in the past 12 months.
• Culture confirmation and resolution of the signs and symptoms of the initial VVC episode (with treatment).
• Able to take oral tablets and capsules.

Key exclusion Criteria:

• Vaginal conditions other than recurrent VVC that may interfere with the diagnosis or evaluation of response to therapy.
• Recent use of systemic and/or topical vaginal antifungal products.
• Pregnant.
• History of major system organ disease.

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: NCT04029116
• Other Study ID Numbers: SCY-078-304
• 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: Not Provided
• 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: Nkechi Azie, MD; Scynexis, Inc.

• PRS Account: Scynexis, Inc.
• Verification Date: April 2022