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

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 (AVVC).

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 (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

Interventional

Enrollment (Actual)

455

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

  • Bulgaria
      • Asenovgrad, Bulgaria, 4230
        • Multiprofile Hospital for Active Treatment -Asenovgrad EOOD
      • Blagoevgrad, Bulgaria, 2700
        • MHAT Puls AD - PPDS
      • Chirpan, Bulgaria, 6200
        • Multiprofile Hospital for Active Treatment - Chirpan EOOD
      • Dupnitsa, Bulgaria, 2600
        • Medical Center Asklepii OOD
      • Gabrovo, Bulgaria, 5300
        • Diagnostic-Consultative Center I-Gabrovo EOOD
      • Gabrovo, Bulgaria, 5300
        • Multiprofile Hospital For Active Treatment Dr Tota Venkova
      • Gorna Oryahovitsa, Bulgaria, 5100
        • Multiprofile Hospital for Active Treatment Sv. Ivan Rilski - Gorna Oryahovitsa EOOD
      • Lom, Bulgaria, 3600
        • Multiprofile Hospital for Active Treatment- Sveti Nikolay Chudotvoretz - LOM EOOD
      • Lovech, Bulgaria, 5500
        • Multiprofile Hospital for Active Treatment - Prof. Dr. Paraskev Stoyanov AD
      • Montana, Bulgaria, 3400
        • MHAT Stamen Iliev AD
      • Pazardzhik, Bulgaria, 4400
        • Multiprofile Hospital for Active Treatment - Pazardzhik AD
      • Plovdiv, Bulgaria, 4000
        • Multiprofile Hospital for Active Treatment Trimontsium OOD
      • Samokov, Bulgaria, 2000
        • Multiprofile Hospital for Active Treatment - Samokov EOOD
      • Sevlievo, Bulgaria, 5400
        • Medical Center-1-Sevlievo EOOD
      • Shumen, Bulgaria, 9700
        • Multiprofile Hospital for Active Treatment Shumen
      • Smolyan, Bulgaria, 4700
        • Multiprofile Hospital For Active Treatment - Dr. Bratan Shukerov AD
      • Sofia, Bulgaria, 1407
        • Medical Center Excelsior OOD - PPDS
      • Sofia, Bulgaria, 1618
        • Diagnostic Consultative CTR - XX - Sofia - EOOD
      • Sofia, Bulgaria, 1680
        • Medical center Vip Clinic OOD
      • Veliko Tarnovo, Bulgaria, 5000
        • Medical Center Medica Plus OOD
  • United States
    • Arizona
      • Mesa, Arizona, United States, 85209
        • Mesa OB-GYN
    • Colorado
      • Lakewood, Colorado, United States, 80228
        • Red Rocks OBGYN
    • Connecticut
      • New Haven, Connecticut, United States, 06511
        • Planned Parenthood Southern New England
    • Florida
      • Hialeah, Florida, United States, 33016
        • New Generation Medical Research
      • North Miami, Florida, United States, 33161
        • Healthcare Clinical Data Inc
      • Sarasota, Florida, United States, 34239
        • Physician Care Clinical Research LLC
      • West Palm Beach, Florida, United States, 33409
        • CCT LLC - A VitaLink Company- PPDS
    • Georgia
      • Sandy Springs, Georgia, United States, 30328
        • Mount Vernon Clinical Research, LLC
      • Savannah, Georgia, United States, 31406
        • Fellows Research Alliance Inc
    • Idaho
      • Idaho Falls, Idaho, United States, 83404
        • Rosemark Women Care Specialists
    • Louisiana
      • Marrero, Louisiana, United States, 70072
        • Praetorian Pharmaceutical Research, LLC
    • Missouri
      • Florissant, Missouri, United States, 63033
        • North County Health Center, Planned Parenthood of the St. Louis Region and Southwest Missouri
    • Nevada
      • Las Vegas, Nevada, United States, 89123
        • Clinical Research Center of Nevada
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Planned Parenthood North Central Southern New Jersey (PPNCSNJ)
    • North Carolina
      • Fayetteville, North Carolina, United States, 28304
        • Carolina Institute for Clinical Research - M3 Wake Research
    • Pennsylvania
      • Erie, Pennsylvania, United States, 16507
        • Obstetrics and Gynecology Associates of Erie, PC
      • Philadelphia, Pennsylvania, United States, 19107
        • Planned Parenthood Southeastern Pennsylvania The Elizabeth Blackwell Health Center
    • South Carolina
      • Bluffton, South Carolina, United States, 29910
        • Fellows Research Alliance Inc
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • Chattanooga Medical Research Inc
    • Texas
      • Fort Worth, Texas, United States, 76104
        • Signature GYN Services, Pllc
      • Irving, Texas, United States, 75062
        • Brownstone Clinical Trials, LLC

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% 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.

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Matching Placebo
Drug: Placebo
Matching Placebo
Experimental: Ibrexafungerp (SCY-078)
300 mg BID for one day
Drug: Ibrexafungerp
Ibrexafungerp 300mg BID for one 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
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
The 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
The 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
The percentage of subjects with complete resolution of signs and symptoms at the Follow-up (FU) visit
Day 25
Safety and Tolerability of Ibrexafungerp
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.

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)

June 7, 2019

Primary Completion (Actual)

March 29, 2020

Study Completion (Actual)

April 29, 2020

Study Registration Dates

First Submitted

June 12, 2019

First Submitted That Met QC Criteria

June 12, 2019

First Posted (Actual)

June 17, 2019

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

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCY-078-306

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

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.

Clinical Trials on Candida Vulvovaginitis

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ukraine

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe