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

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ClinicalTrials.gov Identifier: NCT04029116
Recruitment Status : Recruiting
First Posted : July 23, 2019
Last Update Posted : September 25, 2020
Sponsor:
Information provided by (Responsible Party):
Scynexis, Inc.

Tracking Information
First Submitted Date  ICMJE July 19, 2019
First Posted Date  ICMJE July 23, 2019
Last Update Posted Date September 25, 2020
Actual Study Start Date  ICMJE September 23, 2019
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase 3 Study of Oral Ibrexafungerp (SCY-078) Vs. Placebo in Subjects With Recurrent Vulvovaginal Candidiasis (VVC)
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE 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  ICMJE Recurrent Vulvovaginal Candidiasis
Intervention  ICMJE
  • 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  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 22, 2019)		 320
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2021
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Ages  ICMJE 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Philip Deane 201 688 2241 ext 2241 philip.deane@scynexis.com
Contact: Nkechi Azie, MD Nkechi.azie@scynexis.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04029116
Other Study ID Numbers  ICMJE 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  ICMJE Not Provided
Responsible Party Scynexis, Inc.
Study Sponsor  ICMJE Scynexis, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Nkechi Azie, MD Scynexis, Inc.
PRS Account Scynexis, Inc.
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP