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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ibrexafungerp (SCY-078) | Experimental | 300 mg orally every 12 hrs for 1 day (2 doses in 1 day) |
|
| Placebo | Placebo Comparator | Matching Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ibrexafungerp | Drug | Ibrexafungerp 300 mg BID for 1 day |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Day 8-14 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Day 8-14 |
| Clinical Cure and Mycological Eradication (Responder Outcome) |
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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.
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| Name | Affiliation | Role |
|---|---|---|
| David Angulo, MD | Scynexis, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| Precision Trials AZ, LLC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36255448 | Derived | 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. |
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Participants were recruited based on physician referral at 28 medical centers between 04Jan2019 and 04Sep2019.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ibrexafungerp (SCY-078) | 300 mg orally every 12 hrs for 1 day (2 doses in 1 day) Ibrexafungerp: Ibrexafungerp 300 mg BID for 1 day |
| FG001 | Placebo | Matching Placebo Placebo: Matching placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 12, 2018 | Jun 30, 2021 |
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randomized, placebo-controlled, double-blind study
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| Placebo | Drug | Matching placebo |
|
percentage of subjects with clinical cure and mycological eradication (responder outcome) at the TOC visit |
| Day 8-14 |
| Complete Clinical Response at Follow-Up | 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) | Number of subjects with treatment related adverse events | Up to 29 days |
| Phoenix |
| Arizona |
| 85032 |
| United States |
| Womens' Health Care Research Corp | San Diego | California | 92111 | United States |
| Women's Medical Research Group | Clearwater | Florida | 33759 | United States |
| Altus Research | Lake Worth | Florida | 33461 | United States |
| OBGYN Assoc of Mid Florida | Leesburg | Florida | 34748 | United States |
| New Age Medical Research Corporation | Miami | Florida | 33186 | United States |
| Clinical Trials Management LLC | Covington | Louisiana | 70006 | United States |
| Clinical Trials Management LLC | Metairie | Louisiana | 70006 | United States |
| Unified Women's Clinical Research- Hagerstown | Hagerstown | Maryland | 21740 | United States |
| Wayne State University | Detroit | Michigan | 48201 | United States |
| Consultants In Women's Healthcare, Inc. | St Louis | Missouri | 63131 | United States |
| Center For Women's Health and Wellness LLC - Interspond - PPDS | Lawrenceville | New Jersey | 08648 | United States |
| Lawrence OB/GYN Clinical Research, LLC | Lawrenceville | New Jersey | 08648 | United States |
| GYN Center for Women PA | Durham | North Carolina | 27612 | United States |
| Carolina Women's Research and Wellness Center | Durham | North Carolina | 27713 | United States |
| Unified Women's Clinical Research Greensboro | Greensboro | North Carolina | 27408 | United States |
| Unified Women's Clinical Research | Morehead City | North Carolina | 28557 | United States |
| Unified Women's Clinical Research Raleigh | Raleigh | North Carolina | 27607 | United States |
| Unified Women's Clinical Research - Lyndhurst Clinical Research | Winston-Salem | North Carolina | 27103 | United States |
| Medical Research South | Charleston | South Carolina | 29414 | United States |
| Magnolia Ob/Gyn Research Center, LLC | Myrtle Beach | South Carolina | 29572 | United States |
| Medical Research Center of Memphis | Memphis | Tennessee | 38120 | United States |
| TMC Life Research Inc | Houston | Texas | 77054 | United States |
| Group For Women | Norfolk | Virginia | 23502 | United States |
| Withdrawn Before Treatment |
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| Withdrawn Before TOC |
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| Completed the TOC Visit |
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| Withdrawn At or After the TOC Visit |
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| COMPLETED |
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| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ibrexafungerp (SCY-078) | 300 mg orally every 12 hrs for 1 day (2 doses in 1 day) Ibrexafungerp: Ibrexafungerp 300 mg BID for 1 day |
| BG001 | Placebo | Matching Placebo Placebo: Matching placebo |
| 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 | Number | 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 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 | mITT | Posted | Count of Participants | Participants | Day 8-14 |
|
|
| |||||||||||||||||||||||||||||||
| Secondary | 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 | mITT | Posted | Count of Participants | Participants | Day 8-14 |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Clinical Cure and Mycological Eradication (Responder Outcome) | percentage of subjects with clinical cure and mycological eradication (responder outcome) at the TOC visit | mITT | Posted | Count of Participants | Participants | Day 8-14 |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Complete Clinical Response at Follow-Up | percentage of subjects with complete resolution of signs and symptoms at the Follow-up (FU) visit | mITT | Posted | Count of Participants | Participants | Day 25 |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Overall Treatment-Emergent Adverse Events (Safety Set) | Number of subjects with treatment related adverse events | Posted | Count of Participants | Participants | Up to 29 days |
|
|
4 weeks after last dose
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ibrexafungerp (SCY-078) | 300 mg orally every 12 hrs for 1 day (2 doses in 1 day) Ibrexafungerp: Ibrexafungerp 300 mg BID for 1 day | 0 | 247 | 1 | 247 | 117 | 247 |
| EG001 | Placebo | Matching Placebo Placebo: Matching placebo | 0 | 124 | 2 | 124 | 34 | 124 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypokalaemia | Investigations | Systematic Assessment |
| ||
| Diabetes mellitus | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Pneumonia and bronchial hyperreactivity | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Abdominal discomfort | Gastrointestinal disorders | Systematic Assessment |
| ||
| Bacterial vaginosis | Infections and infestations | Systematic Assessment |
| ||
| Headache | Nervous system disorders | Systematic Assessment |
|
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| 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 | Oct 16, 2019 | Jun 30, 2021 | SAP_001.pdf |
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| 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 |
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| ID | Term |
|---|---|
| C569338 | ibrexafungerp |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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