Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of oral ibrexafungerp (formerly "SCY-078") compared to placebo in female subjects 12 years and older with recurrent VVC (RVVC).
This study is a Phase 3, multicenter, randomized, double-blind study to evaluate the efficacy and safety of oral ibrexafungerp (formerly "SCY-078") compared to placebo in female subjects 12 years and older with RVVC. The primary objective of the study is to evaluate the efficacy of oral ibrexafungerp in preventing recurrences of VVC in subjects with RVVC based on Clinical Success. Approximately 320 subjects are planned to be enrolled into the study. All subjects will receive treatment with oral fluconazole for their acute episode present at screening. Subjects who respond to fluconazole for their acute episode will be enrolled in the prevention of recurrence phase of the study and randomized to ibrexafungerp or placebo.
Subjects who fail treatment with fluconazole for their acute episode will be included in a nested open label Sub-Study, in which they will be offered one-day oral ibrexafungerp for their unresolved acute episode.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ibrexafungerp | Experimental | Oral Fluconazole 150 mg every 72 hours for 3 doses followed by Oral Ibrexafungerp 300 mg BID (one day) every 4 weeks for a total of 6 dosing days |
|
| Placebo | Placebo Comparator | Oral Fluconazole 150 mg every 72 hours for 3 doses followed by Oral Placebo BID (one day) every 4 weeks for a total of 6 dosing days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluconazole Tablet | Drug | 150 mg every 72 hours for 3 doses |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Success | Efficacy as measured by the percentage of subjects with documented Clinical Success. | Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| The Percentage of Subjects With no Mycologically Proven Recurrence | Efficacy as measured by the percentage of subjects with no Mycologically Proven Recurrence | Week 24 |
| Safety and Tolerability |
Not provided
Key Inclusion Criteria:
Key exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Nkechi Azie, MD | Scynexis, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Precision Trials LLC | Phoenix | Arizona | 85032 | United States | ||
| Women's Healthcare Research Corp |
440 subjects were enrolled into the acute phase of the study with 156 of them discontinuing. 260 then entered into the recurrence phase
Participants were recruited based on physician referral at 49 medical centers between 21Oct2019 and 29Nov2021
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Ibrexafungerp | Oral Fluconazole 150 mg every 72 hours for 3 doses followed by Oral Ibrexafungerp 300 mg BID (one day) every 4 weeks for a total of 6 dosing days Fluconazole Tablet: 150 mg every 72 hours for 3 doses IBREXAFUNGERP: 300 mg BID (one day) every 4 weeks for a total of 6 dosing days |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 3, 2019 | Jan 31, 2023 |
Not provided
Not provided
Open label (acute phase treatment) followed by Randomized, Double Blinded phase
Not provided
Not provided
Not provided
| IBREXAFUNGERP |
| Drug |
300 mg BID (one day) every 4 weeks for a total of 6 dosing days |
|
|
| Placebo oral tablet | Drug | BID (one day) every 4 weeks for a total of 6 dosing days |
|
Safety as measured by the number of subjects who discontinue due to treatment related adverse events.
| Week 24 |
| San Diego |
| California |
| 92111 |
| United States |
| Altus Research - Hunt - PPDS | Lake Worth | Florida | 33461 | United States |
| New Age Medical Research Corporation | Miami | Florida | 33186 | United States |
| Healthcare Clinical Data Inc | North Miami | Florida | 33161 | United States |
| Clinical Research Prime - ClinEdge - PPDS | Idaho Falls | Idaho | 83404 | United States |
| Clinical Trials Management | Covington | Louisiana | 70433 | United States |
| Women Under Study, LLC | New Orleans | Louisiana | 70125 | United States |
| Unified Women's Clinical Research | Hagerstown | Maryland | 21740 | United States |
| Wayne State University | Detroit | Michigan | 48201 | United States |
| Center For Women's Health and Wellness LLC | Lawrenceville | New Jersey | 08648 | United States |
| Lawrence Obstetrics Gynecology Clinical Research LLC | Lawrenceville | New Jersey | 08648 | United States |
| Bosque Women's Care | Albuquerque | New Mexico | 87109 | United States |
| Carolina Women's Research and Wellness Center | Durham | North Carolina | 27713 | United States |
| Unified Womens CLinical Research | Greensboro | North Carolina | 27408 | United States |
| Unified Women's Clinical Research Raleigh | Raleigh | North Carolina | 27607 | United States |
| M3 Wake Research, Inc | Raleigh | North Carolina | 27612 | United States |
| Group For Women | Winston-Salem | North Carolina | 27103 | United States |
| Lyndhurst Clinical Research | Winston-Salem | North Carolina | 27103 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Obstetrics and Gynecology Associates of Erie, PC | Erie | Pennsylvania | 16507 | United States |
| Jefferson University Hospital | Philadelphia | Pennsylvania | 19107 | United States |
| Chattanooga Medical Research Inc | Chattanooga | Tennessee | 37404 | United States |
| Medical Research Center of Memphis, LLC | Memphis | Tennessee | 38120 | United States |
| TMC Life Research Inc | Houston | Texas | 77054 | United States |
| Placebo |
Oral Fluconazole 150 mg every 72 hours for 3 doses followed by Oral Placebo BID (one day) every 4 weeks for a total of 6 dosing days Fluconazole Tablet: 150 mg every 72 hours for 3 doses Placebo oral tablet: BID (one day) every 4 weeks for a total of 6 dosing days |
| Discontinued |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Intent-to-Treat Set
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Ibrexafungerp | Oral Fluconazole 150 mg every 72 hours for 3 doses followed by Oral Ibrexafungerp 300 mg BID (one day) every 4 weeks for a total of 6 dosing days Fluconazole Tablet: 150 mg every 72 hours for 3 doses IBREXAFUNGERP: 300 mg BID (one day) every 4 weeks for a total of 6 dosing days |
| BG001 | Placebo | Oral Fluconazole 150 mg every 72 hours for 3 doses followed by Oral Placebo BID (one day) every 4 weeks for a total of 6 dosing days Fluconazole Tablet: 150 mg every 72 hours for 3 doses Placebo oral tablet: BID (one day) every 4 weeks for a total of 6 dosing days |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Clinical Success | Efficacy as measured by the percentage of subjects with documented Clinical Success. | Intent-to-Treat Set | Posted | Count of Participants | Participants | Week 24 |
|
|
| |||||||||||||||||||||||||||||||
| Secondary | The Percentage of Subjects With no Mycologically Proven Recurrence | Efficacy as measured by the percentage of subjects with no Mycologically Proven Recurrence | Intent-to-Treat Set | Posted | Count of Participants | Participants | Week 24 |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Safety and Tolerability | Safety as measured by the number of subjects who discontinue due to treatment related adverse events. | Safety Population | Posted | Count of Participants | Participants | Week 24 |
|
|
up to 38 weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ibrexafungerp | Oral Fluconazole 150 mg every 72 hours for 3 doses followed by Oral Ibrexafungerp 300 mg BID (one day) every 4 weeks for a total of 6 dosing days Fluconazole Tablet: 150 mg every 72 hours for 3 doses IBREXAFUNGERP: 300 mg BID (one day) every 4 weeks for a total of 6 dosing days | 0 | 130 | 1 | 130 | 66 | 130 |
| EG001 | Placebo | Oral Fluconazole 150 mg every 72 hours for 3 doses followed by Oral Placebo BID (one day) every 4 weeks for a total of 6 dosing days Fluconazole Tablet: 150 mg every 72 hours for 3 doses Placebo oral tablet: BID (one day) every 4 weeks for a total of 6 dosing days | 0 | 130 | 0 | 130 | 41 | 130 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 | Infections and infestations | Systematic Assessment |
| ||
| Influenza | Infections and infestations | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Abdominal pain upper | Gastrointestinal disorders | Systematic Assessment |
| ||
| Bacterial vaginosis | Infections and infestations | Systematic Assessment |
| ||
| COVID-19 | Infections and infestations | Systematic Assessment |
| ||
| Headache | Nervous system disorders | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. David Angulo | SCYNEXIS | (201) 884-5471 | david.angulo@scynexis.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 14, 2022 | Jan 31, 2023 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D002181 | Candidiasis, Vulvovaginal |
| ID | Term |
|---|---|
| D002177 | Candidiasis |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D014848 | Vulvovaginitis |
| D014627 | Vaginitis |
| D014623 | Vaginal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D014847 | Vulvitis |
| D014845 | Vulvar Diseases |
| D000091662 | Genital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D015725 | Fluconazole |
| C569338 | ibrexafungerp |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Bulgaria |
|
| Poland |
|
| Russia |
|
|
|