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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03734991
Recruitment Status : Completed
First Posted : November 8, 2018
Last Update Posted : September 19, 2019
Sponsor:
Information provided by (Responsible Party):
Scynexis, Inc.

Tracking Information
First Submitted Date  ICMJE October 30, 2018
First Posted Date  ICMJE November 8, 2018
Last Update Posted Date September 19, 2019
Actual Study Start Date  ICMJE January 4, 2019
Actual Primary Completion Date August 21, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (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 ]
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 Efficacy and Safety of Oral Ibrexafungerp (SCY-078) vs. Placebo in Subjects With Acute Vulvovaginal Candidiasis (VANISH 303)
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
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  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: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Candida Vulvovaginitis
Intervention  ICMJE
  • Drug: Ibrexafungerp
    Ibrexafungerp 300 mg BID for 1 day
    Other Name: SCY-078
  • Drug: Placebo
    Matching placebo
Study Arms  ICMJE
  • 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 * 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 Completed
Actual Enrollment  ICMJE
 (submitted: September 17, 2019)
376
Original Estimated Enrollment  ICMJE
 (submitted: November 7, 2018)
400
Actual Study Completion Date  ICMJE September 4, 2019
Actual Primary Completion Date August 21, 2019   (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% 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  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 information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03734991
Other Study ID Numbers  ICMJE 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  ICMJE
Plan to Share IPD: No
Responsible Party Scynexis, Inc.
Study Sponsor  ICMJE Scynexis, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: David Angulo, MD Scynexis, Inc.
PRS Account Scynexis, Inc.
Verification Date September 2019

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