Back to resultsEfficacy and Safety of Oral Ibrexafungerp (SCY-078) vs. Placebo in Subjects With Acute Vulvovaginal Candidiasis (VANISH 303)
Primary Purpose
Candida Vulvovaginitis
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Ibrexafungerp
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Candida Vulvovaginitis
Eligibility Criteria
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.
Sites / Locations
- University of Alabama at Birmingham
- Precision Trials AZ, LLC
- Womens' Health Care Research Corp
- Women's Medical Research Group
- Altus Research
- OBGYN Assoc of Mid Florida
- New Age Medical Research Corporation
- Clinical Trials Management LLC
- Clinical Trials Management LLC
- Unified Women's Clinical Research- Hagerstown
- Wayne State University
- Consultants In Women's Healthcare, Inc.
- Center For Women's Health and Wellness LLC - Interspond - PPDS
- Lawrence OB/GYN Clinical Research, LLC
- GYN Center for Women PA
- Carolina Women's Research and Wellness Center
- Unified Women's Clinical Research Greensboro
- Unified Women's Clinical Research
- Unified Women's Clinical Research Raleigh
- Unified Women's Clinical Research - Lyndhurst Clinical Research
- Medical Research South
- Magnolia Ob/Gyn Research Center, LLC
- Medical Research Center of Memphis
- TMC Life Research Inc
- Group For Women
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Ibrexafungerp (SCY-078)
Placebo
Arm Description
300 mg orally every 12 hrs for 1 day (2 doses in 1 day)
Matching Placebo
Outcomes
Primary Outcome Measures
Clinical Cure (Complete Resolution of Signs and Symptoms)
measured by the percentage of subjects with clinical cure (complete resolution of signs and symptoms) at the test-of-cure (TOC) visit
Secondary Outcome Measures
Mycological Eradication (Negative Culture for Growth of Yeast)
percentage of subjects with mycological eradication (negative culture for growth of Candida species) at the TOC visit
Clinical Cure and Mycological Eradication (Responder Outcome)
percentage of subjects with clinical cure and mycological eradication (responder outcome) at the TOC visit
Complete Clinical Response at Follow-Up
percentage of subjects with complete resolution of signs and symptoms at the Follow-up (FU) visit
Overall Treatment-Emergent Adverse Events (Safety Set)
Number of subjects with treatment related adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03734991
Brief Title
Efficacy and Safety of Oral Ibrexafungerp (SCY-078) vs. Placebo in Subjects With Acute Vulvovaginal Candidiasis (VANISH 303)
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
January 4, 2019 (Actual)
Primary Completion Date
August 21, 2019 (Actual)
Study Completion Date
September 4, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Scynexis, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Candida Vulvovaginitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
randomized, placebo-controlled, double-blind study
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
376 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ibrexafungerp (SCY-078)
Arm Type
Experimental
Arm Description
300 mg orally every 12 hrs for 1 day (2 doses in 1 day)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matching Placebo
Intervention Type
Drug
Intervention Name(s)
Ibrexafungerp
Other Intervention Name(s)
SCY-078
Intervention Description
Ibrexafungerp 300 mg BID for 1 day
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo
Primary Outcome Measure Information:
Title
Clinical Cure (Complete Resolution of Signs and Symptoms)
Description
measured by the percentage of subjects with clinical cure (complete resolution of signs and symptoms) at the test-of-cure (TOC) visit
Time Frame
Day 8-14
Secondary Outcome Measure Information:
Title
Mycological Eradication (Negative Culture for Growth of Yeast)
Description
percentage of subjects with mycological eradication (negative culture for growth of Candida species) at the TOC visit
Time Frame
Day 8-14
Title
Clinical Cure and Mycological Eradication (Responder Outcome)
Description
percentage of subjects with clinical cure and mycological eradication (responder outcome) at the TOC visit
Time Frame
Day 8-14
Title
Complete Clinical Response at Follow-Up
Description
percentage of subjects with complete resolution of signs and symptoms at the Follow-up (FU) visit
Time Frame
Day 25
Title
Overall Treatment-Emergent Adverse Events (Safety Set)
Description
Number of subjects with treatment related adverse events
Time Frame
Up to 29 days
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Angulo, MD
Organizational Affiliation
Scynexis, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Precision Trials AZ, LLC
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
Womens' Health Care Research Corp
City
San Diego
State/Province
California
ZIP/Postal Code
92111
Country
United States
Facility Name
Women's Medical Research Group
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33759
Country
United States
Facility Name
Altus Research
City
Lake Worth
State/Province
Florida
ZIP/Postal Code
33461
Country
United States
Facility Name
OBGYN Assoc of Mid Florida
City
Leesburg
State/Province
Florida
ZIP/Postal Code
34748
Country
United States
Facility Name
New Age Medical Research Corporation
City
Miami
State/Province
Florida
ZIP/Postal Code
33186
Country
United States
Facility Name
Clinical Trials Management LLC
City
Covington
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Clinical Trials Management LLC
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Unified Women's Clinical Research- Hagerstown
City
Hagerstown
State/Province
Maryland
ZIP/Postal Code
21740
Country
United States
Facility Name
Wayne State University
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Consultants In Women's Healthcare, Inc.
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63131
Country
United States
Facility Name
Center For Women's Health and Wellness LLC - Interspond - PPDS
City
Lawrenceville
State/Province
New Jersey
ZIP/Postal Code
08648
Country
United States
Facility Name
Lawrence OB/GYN Clinical Research, LLC
City
Lawrenceville
State/Province
New Jersey
ZIP/Postal Code
08648
Country
United States
Facility Name
GYN Center for Women PA
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Carolina Women's Research and Wellness Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27713
Country
United States
Facility Name
Unified Women's Clinical Research Greensboro
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27408
Country
United States
Facility Name
Unified Women's Clinical Research
City
Morehead City
State/Province
North Carolina
ZIP/Postal Code
28557
Country
United States
Facility Name
Unified Women's Clinical Research Raleigh
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Unified Women's Clinical Research - Lyndhurst Clinical Research
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Medical Research South
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29414
Country
United States
Facility Name
Magnolia Ob/Gyn Research Center, LLC
City
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29572
Country
United States
Facility Name
Medical Research Center of Memphis
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
TMC Life Research Inc
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
Facility Name
Group For Women
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
36255448
Citation
Goje O, Sobel R, Nyirjesy P, Goldstein SR, Spitzer M, Faught B, Larson S, King T, Azie NE, Angulo D, Sobel JD. Oral Ibrexafungerp for Vulvovaginal Candidiasis Treatment: An Analysis of VANISH 303 and VANISH 306. J Womens Health (Larchmt). 2023 Feb;32(2):178-186. doi: 10.1089/jwh.2022.0132. Epub 2022 Oct 17.
Results Reference
derived
Learn more about this trial
Efficacy and Safety of Oral Ibrexafungerp (SCY-078) vs. Placebo in Subjects With Acute Vulvovaginal Candidiasis (VANISH 303)
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