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

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ClinicalTrials.gov Identifier: NCT03987620
Recruitment Status : Recruiting
First Posted : June 17, 2019
Last Update Posted : October 2, 2019
Sponsor:
Collaborator:
PPD
Information provided by (Responsible Party):
Scynexis, Inc.

Tracking Information
First Submitted Date  ICMJE June 12, 2019
First Posted Date  ICMJE June 17, 2019
Last Update Posted Date October 2, 2019
Actual Study Start Date  ICMJE June 7, 2019
Estimated Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03987620 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 14, 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 tolerability of Ibrexafungerp [ Time Frame: Up to 29 Days ]
    Number of subjects with treatment related adverse events
Original Secondary Outcome Measures  ICMJE
 (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  ICMJE Efficacy and Safety of Oral Ibrexafungerp (SCY-078) vs. Placebo in Subjects With Acute Vulvovaginal Candidiasis
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Randomized, placebo-controlled, double-blind study
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Candida Vulvovaginitis
Intervention  ICMJE
  • Drug: Ibrexafungerp
    Ibrexafungerp 300mg BID for one day
    Other Name: SCY-078
  • Drug: Placebo
    Matching Placebo
Study Arms  ICMJE
  • Experimental: Ibrexafungerp (SCY-078)
    300 mg BID for one day
    Intervention: Drug: Ibrexafungerp
  • Placebo Comparator: Placebo
    Matching Placebo
    Intervention: Drug: Placebo
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: June 12, 2019)
366
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2020
Estimated Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  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 O Deane, M.Sc 201 688 2241 philip.deane@scynexis.com
Contact: David Angulo, MD 786 942 3854 david.angulo@scynexis.com
Listed Location Countries  ICMJE Bulgaria,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03987620
Other Study ID Numbers  ICMJE 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  ICMJE Not Provided
Responsible Party Scynexis, Inc.
Study Sponsor  ICMJE Scynexis, Inc.
Collaborators  ICMJE PPD
Investigators  ICMJE Not Provided
PRS Account Scynexis, Inc.
Verification Date October 2019

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