Efficacy and Safety of Oral Ibrexafungerp (SCY-078) vs. Placebo in Subjects With Acute Vulvovaginal Candidiasis (Vanish 306)
Primary Purpose
Candida Vulvovaginitis
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Ibrexafungerp
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Candida Vulvovaginitis focused on measuring Vaginitis, Yeast infection
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% 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.
Sites / Locations
- Mesa OB-GYN
- Red Rocks OBGYN
- Planned Parenthood Southern New England
- New Generation Medical Research
- Healthcare Clinical Data Inc
- Physician Care Clinical Research LLC
- CCT LLC - A VitaLink Company- PPDS
- Mount Vernon Clinical Research, LLC
- Fellows Research Alliance Inc
- Rosemark Women Care Specialists
- Praetorian Pharmaceutical Research, LLC
- North County Health Center, Planned Parenthood of the St. Louis Region and Southwest Missouri
- Clinical Research Center Of Nevada
- Planned Parenthood North Central Southern New Jersey (PPNCSNJ)
- Carolina Institute for Clinical Research - M3 Wake Research
- Obstetrics and Gynecology Associates of Erie, PC
- Planned Parenthood Southeastern Pennsylvania The Elizabeth Blackwell Health Center
- Fellows Research Alliance Inc
- Chattanooga Medical Research Inc
- Signature GYN Services, PLLC
- Brownstone Clinical Trials, LLC
- Multiprofile Hospital for Active Treatment -Asenovgrad EOOD
- MHAT Puls AD - PPDS
- Multiprofile Hospital for Active Treatment - Chirpan EOOD
- Medical Center Asklepii OOD
- Diagnostic-Consultative Center I-Gabrovo EOOD
- Multiprofile Hospital For Active Treatment Dr Tota Venkova
- Multiprofile Hospital for Active Treatment Sv. Ivan Rilski - Gorna Oryahovitsa EOOD
- Multiprofile Hospital for Active Treatment- Sveti Nikolay Chudotvoretz - LOM EOOD
- Multiprofile Hospital for Active Treatment - Prof. Dr. Paraskev Stoyanov AD
- MHAT Stamen Iliev AD
- Multiprofile Hospital For Active Treatment - Pazardzhik AD
- Multiprofile Hospital for Active Treatment Trimontsium OOD
- Multiprofile Hospital for Active Treatment - Samokov EOOD
- Medical Center-1-Sevlievo EOOD
- Multiprofile Hospital for Active Treatment Shumen
- Multiprofile Hospital For Active Treatment - Dr. Bratan Shukerov AD
- Medical Center Excelsior OOD - PPDS
- Diagnostic Consultative CTR - XX - Sofia - EOOD
- Medical center Vip Clinic OOD
- Medical Center Medica Plus OOD
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Ibrexafungerp (SCY-078)
Placebo
Arm Description
300 mg BID for one day
Matching Placebo
Outcomes
Primary Outcome Measures
Clinical Cure (Complete Resolution of Signs and Symptoms)
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)
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)
The percentage of subjects with clinical cure and mycological eradication (responder outcome) at the TOC visit
Complete Clinical Response at Follow-up
The percentage of subjects with complete resolution of signs and symptoms at the Follow-up (FU) visit
Safety and Tolerability of Ibrexafungerp
Number of subjects with treatment related adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03987620
Brief Title
Efficacy and Safety of Oral Ibrexafungerp (SCY-078) vs. Placebo in Subjects With Acute Vulvovaginal Candidiasis
Acronym
Vanish 306
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 (AVVC).
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
June 7, 2019 (Actual)
Primary Completion Date
March 29, 2020 (Actual)
Study Completion Date
April 29, 2020 (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
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 (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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Candida Vulvovaginitis
Keywords
Vaginitis, Yeast infection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Randomized, placebo-controlled, double-blind study
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
455 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ibrexafungerp (SCY-078)
Arm Type
Experimental
Arm Description
300 mg BID for one 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 300mg BID for one 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
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
The 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
The 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
The percentage of subjects with complete resolution of signs and symptoms at the Follow-up (FU) visit
Time Frame
Day 25
Title
Safety and Tolerability of Ibrexafungerp
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% 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.
Facility Information:
Facility Name
Mesa OB-GYN
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85209
Country
United States
Facility Name
Red Rocks OBGYN
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80228
Country
United States
Facility Name
Planned Parenthood Southern New England
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
Facility Name
New Generation Medical Research
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Healthcare Clinical Data Inc
City
North Miami
State/Province
Florida
ZIP/Postal Code
33161
Country
United States
Facility Name
Physician Care Clinical Research LLC
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
CCT LLC - A VitaLink Company- PPDS
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
Country
United States
Facility Name
Mount Vernon Clinical Research, LLC
City
Sandy Springs
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Fellows Research Alliance Inc
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31406
Country
United States
Facility Name
Rosemark Women Care Specialists
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
Praetorian Pharmaceutical Research, LLC
City
Marrero
State/Province
Louisiana
ZIP/Postal Code
70072
Country
United States
Facility Name
North County Health Center, Planned Parenthood of the St. Louis Region and Southwest Missouri
City
Florissant
State/Province
Missouri
ZIP/Postal Code
63033
Country
United States
Facility Name
Clinical Research Center Of Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89123
Country
United States
Facility Name
Planned Parenthood North Central Southern New Jersey (PPNCSNJ)
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Carolina Institute for Clinical Research - M3 Wake Research
City
Fayetteville
State/Province
North Carolina
ZIP/Postal Code
28304
Country
United States
Facility Name
Obstetrics and Gynecology Associates of Erie, PC
City
Erie
State/Province
Pennsylvania
ZIP/Postal Code
16507
Country
United States
Facility Name
Planned Parenthood Southeastern Pennsylvania The Elizabeth Blackwell Health Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Fellows Research Alliance Inc
City
Bluffton
State/Province
South Carolina
ZIP/Postal Code
29910
Country
United States
Facility Name
Chattanooga Medical Research Inc
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
Signature GYN Services, PLLC
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Brownstone Clinical Trials, LLC
City
Irving
State/Province
Texas
ZIP/Postal Code
75062
Country
United States
Facility Name
Multiprofile Hospital for Active Treatment -Asenovgrad EOOD
City
Asenovgrad
ZIP/Postal Code
4230
Country
Bulgaria
Facility Name
MHAT Puls AD - PPDS
City
Blagoevgrad
ZIP/Postal Code
2700
Country
Bulgaria
Facility Name
Multiprofile Hospital for Active Treatment - Chirpan EOOD
City
Chirpan
ZIP/Postal Code
6200
Country
Bulgaria
Facility Name
Medical Center Asklepii OOD
City
Dupnitsa
ZIP/Postal Code
2600
Country
Bulgaria
Facility Name
Diagnostic-Consultative Center I-Gabrovo EOOD
City
Gabrovo
ZIP/Postal Code
5300
Country
Bulgaria
Facility Name
Multiprofile Hospital For Active Treatment Dr Tota Venkova
City
Gabrovo
ZIP/Postal Code
5300
Country
Bulgaria
Facility Name
Multiprofile Hospital for Active Treatment Sv. Ivan Rilski - Gorna Oryahovitsa EOOD
City
Gorna Oryahovitsa
ZIP/Postal Code
5100
Country
Bulgaria
Facility Name
Multiprofile Hospital for Active Treatment- Sveti Nikolay Chudotvoretz - LOM EOOD
City
Lom
ZIP/Postal Code
3600
Country
Bulgaria
Facility Name
Multiprofile Hospital for Active Treatment - Prof. Dr. Paraskev Stoyanov AD
City
Lovech
ZIP/Postal Code
5500
Country
Bulgaria
Facility Name
MHAT Stamen Iliev AD
City
Montana
ZIP/Postal Code
3400
Country
Bulgaria
Facility Name
Multiprofile Hospital For Active Treatment - Pazardzhik AD
City
Pazardzhik
ZIP/Postal Code
4400
Country
Bulgaria
Facility Name
Multiprofile Hospital for Active Treatment Trimontsium OOD
City
Plovdiv
ZIP/Postal Code
4000
Country
Bulgaria
Facility Name
Multiprofile Hospital for Active Treatment - Samokov EOOD
City
Samokov
ZIP/Postal Code
2000
Country
Bulgaria
Facility Name
Medical Center-1-Sevlievo EOOD
City
Sevlievo
ZIP/Postal Code
5400
Country
Bulgaria
Facility Name
Multiprofile Hospital for Active Treatment Shumen
City
Shumen
ZIP/Postal Code
9700
Country
Bulgaria
Facility Name
Multiprofile Hospital For Active Treatment - Dr. Bratan Shukerov AD
City
Smolyan
ZIP/Postal Code
4700
Country
Bulgaria
Facility Name
Medical Center Excelsior OOD - PPDS
City
Sofia
ZIP/Postal Code
1407
Country
Bulgaria
Facility Name
Diagnostic Consultative CTR - XX - Sofia - EOOD
City
Sofia
ZIP/Postal Code
1618
Country
Bulgaria
Facility Name
Medical center Vip Clinic OOD
City
Sofia
ZIP/Postal Code
1680
Country
Bulgaria
Facility Name
Medical Center Medica Plus OOD
City
Veliko Tarnovo
ZIP/Postal Code
5000
Country
Bulgaria
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of Oral Ibrexafungerp (SCY-078) vs. Placebo in Subjects With Acute Vulvovaginal Candidiasis
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