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

August 11, 2021 updated by: Scynexis, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

376

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama At Birmingham
    • Arizona
      • Phoenix, Arizona, United States, 85032
        • Precision Trials AZ, LLC
    • California
      • San Diego, California, United States, 92111
        • Womens' Health Care Research Corp
    • Florida
      • Clearwater, Florida, United States, 33759
        • Women's Medical Research Group
      • Lake Worth, Florida, United States, 33461
        • Altus Research
      • Leesburg, Florida, United States, 34748
        • OBGYN Assoc of Mid Florida
      • Miami, Florida, United States, 33186
        • New Age Medical Research Corporation
    • Louisiana
      • Covington, Louisiana, United States, 70006
        • Clinical Trials Management LLC
      • Metairie, Louisiana, United States, 70006
        • Clinical Trials Management LLC
    • Maryland
      • Hagerstown, Maryland, United States, 21740
        • Unified Women's Clinical Research- Hagerstown
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Wayne State University
    • Missouri
      • Saint Louis, Missouri, United States, 63131
        • Consultants in Women's Healthcare, Inc.
    • New Jersey
      • Lawrenceville, New Jersey, United States, 08648
        • Center For Women's Health and Wellness LLC - Interspond - PPDS
      • Lawrenceville, New Jersey, United States, 08648
        • Lawrence OB/GYN Clinical Research, LLC
    • North Carolina
      • Durham, North Carolina, United States, 27612
        • GYN Center for Women PA
      • Durham, North Carolina, United States, 27713
        • Carolina Women's Research and Wellness Center
      • Greensboro, North Carolina, United States, 27408
        • Unified Women's Clinical Research Greensboro
      • Morehead City, North Carolina, United States, 28557
        • Unified Women's Clinical Research
      • Raleigh, North Carolina, United States, 27607
        • Unified Women's Clinical Research Raleigh
      • Winston-Salem, North Carolina, United States, 27103
        • Unified Women's Clinical Research - Lyndhurst Clinical Research
    • South Carolina
      • Charleston, South Carolina, United States, 29414
        • Medical Research South
      • Myrtle Beach, South Carolina, United States, 29572
        • Magnolia Ob/Gyn Research Center, LLC
    • Tennessee
      • Memphis, Tennessee, United States, 38120
        • Medical Research Center of Memphis
    • Texas
      • Houston, Texas, United States, 77054
        • TMC Life Research Inc
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • Group For Women

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Matching Placebo
Drug: Placebo
Matching placebo
Experimental: Ibrexafungerp (SCY-078)
300 mg orally every 12 hrs for 1 day (2 doses in 1 day)
Drug: Ibrexafungerp
Ibrexafungerp 300 mg BID for 1 day
Other Names:
  • SCY-078

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Day 8-14

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Day 8-14
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
Day 8-14
Complete Clinical Response at Follow-Up
Time Frame: Day 25
percentage of subjects with complete resolution of signs and symptoms at the Follow-up (FU) visit
Day 25
Overall Treatment-Emergent Adverse Events (Safety Set)
Time Frame: Up to 29 days
Number of subjects with treatment related adverse events
Up to 29 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Scynexis, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 4, 2019

Primary Completion (Actual)

August 21, 2019

Study Completion (Actual)

September 4, 2019

Study Registration Dates

First Submitted

October 30, 2018

First Submitted That Met QC Criteria

November 7, 2018

First Posted (Actual)

November 8, 2018

Study Record Updates

Last Update Posted (Actual)

September 8, 2021

Last Update Submitted That Met QC Criteria

August 11, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCY-078-303

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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