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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:
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ibrexafungerp (SCY-078) | Experimental | 300 mg BID for one day |
|
| Placebo | Placebo Comparator | Matching Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ibrexafungerp | Drug | Ibrexafungerp 300mg BID for one day |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Day 8-14 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Day 8-14 |
| Clinical Cure and Mycological Eradication (Responder Outcome) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mesa OB-GYN | Mesa | Arizona | 85209 | United States | ||
| Red Rocks OBGYN |
| 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 22 medical center between 07Jun2019 and 07Feb2020.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ibrexafungerp (SCY-078) | 300 mg BID for one day Ibrexafungerp: Ibrexafungerp 300mg BID for one 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 | Nov 20, 2018 | Aug 4, 2021 |
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Randomized, placebo-controlled, double-blind study
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| Placebo | Drug | Matching Placebo |
|
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 | The percentage of subjects with complete resolution of signs and symptoms at the Follow-up (FU) visit | Day 25 |
| Safety and Tolerability of Ibrexafungerp | Number of subjects with treatment related adverse events | Up to 29 Days |
| Lakewood |
| Colorado |
| 80228 |
| United States |
| Planned Parenthood Southern New England | New Haven | Connecticut | 06511 | United States |
| New Generation Medical Research | Hialeah | Florida | 33016 | United States |
| Healthcare Clinical Data Inc | North Miami | Florida | 33161 | United States |
| Physician Care Clinical Research LLC | Sarasota | Florida | 34239 | United States |
| CCT LLC - A VitaLink Company- PPDS | West Palm Beach | Florida | 33409 | United States |
| Mount Vernon Clinical Research, LLC | Sandy Springs | Georgia | 30328 | United States |
| Fellows Research Alliance Inc | Savannah | Georgia | 31406 | United States |
| Rosemark Women Care Specialists | Idaho Falls | Idaho | 83404 | United States |
| Praetorian Pharmaceutical Research, LLC | Marrero | Louisiana | 70072 | United States |
| North County Health Center, Planned Parenthood of the St. Louis Region and Southwest Missouri | Florissant | Missouri | 63033 | United States |
| Clinical Research Center Of Nevada | Las Vegas | Nevada | 89123 | United States |
| Planned Parenthood North Central Southern New Jersey (PPNCSNJ) | Hackensack | New Jersey | 07601 | United States |
| Carolina Institute for Clinical Research - M3 Wake Research | Fayetteville | North Carolina | 28304 | United States |
| Obstetrics and Gynecology Associates of Erie, PC | Erie | Pennsylvania | 16507 | United States |
| Planned Parenthood Southeastern Pennsylvania The Elizabeth Blackwell Health Center | Philadelphia | Pennsylvania | 19107 | United States |
| Fellows Research Alliance Inc | Bluffton | South Carolina | 29910 | United States |
| Chattanooga Medical Research Inc | Chattanooga | Tennessee | 37404 | United States |
| Signature GYN Services, PLLC | Fort Worth | Texas | 76104 | United States |
| Brownstone Clinical Trials, LLC | Irving | Texas | 75062 | United States |
| Multiprofile Hospital for Active Treatment -Asenovgrad EOOD | Asenovgrad | 4230 | Bulgaria |
| MHAT Puls AD - PPDS | Blagoevgrad | 2700 | Bulgaria |
| Multiprofile Hospital for Active Treatment - Chirpan EOOD | Chirpan | 6200 | Bulgaria |
| Medical Center Asklepii OOD | Dupnitsa | 2600 | Bulgaria |
| Diagnostic-Consultative Center I-Gabrovo EOOD | Gabrovo | 5300 | Bulgaria |
| Multiprofile Hospital For Active Treatment Dr Tota Venkova | Gabrovo | 5300 | Bulgaria |
| Multiprofile Hospital for Active Treatment Sv. Ivan Rilski - Gorna Oryahovitsa EOOD | Gorna Oryahovitsa | 5100 | Bulgaria |
| Multiprofile Hospital for Active Treatment- Sveti Nikolay Chudotvoretz - LOM EOOD | Lom | 3600 | Bulgaria |
| Multiprofile Hospital for Active Treatment - Prof. Dr. Paraskev Stoyanov AD | Lovech | 5500 | Bulgaria |
| MHAT Stamen Iliev AD | Montana | 3400 | Bulgaria |
| Multiprofile Hospital For Active Treatment - Pazardzhik AD | Pazardzhik | 4400 | Bulgaria |
| Multiprofile Hospital for Active Treatment Trimontsium OOD | Plovdiv | 4000 | Bulgaria |
| Multiprofile Hospital for Active Treatment - Samokov EOOD | Samokov | 2000 | Bulgaria |
| Medical Center-1-Sevlievo EOOD | Sevlievo | 5400 | Bulgaria |
| Multiprofile Hospital for Active Treatment Shumen | Shumen | 9700 | Bulgaria |
| Multiprofile Hospital For Active Treatment - Dr. Bratan Shukerov AD | Smolyan | 4700 | Bulgaria |
| Medical Center Excelsior OOD - PPDS | Sofia | 1407 | Bulgaria |
| Diagnostic Consultative CTR - XX - Sofia - EOOD | Sofia | 1618 | Bulgaria |
| Medical center Vip Clinic OOD | Sofia | 1680 | Bulgaria |
| Medical Center Medica Plus OOD | Veliko Tarnovo | 5000 | Bulgaria |
| 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 BID for one day Ibrexafungerp: Ibrexafungerp 300mg BID for one 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) | 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) | The 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) | The 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 | The 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 | Safety and Tolerability of Ibrexafungerp | 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 BID for one day Ibrexafungerp: Ibrexafungerp 300mg BID for one day | 0 | 298 | 1 | 298 | 63 | 298 |
| EG001 | Placebo | Matching Placebo Placebo: Matching Placebo | 0 | 151 | 1 | 151 | 15 | 151 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diabetic ketoacidosis | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Gastrointestinal bacterial infection | Gastrointestinal disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | 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_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 24, 2020 | Aug 4, 2021 | SAP_002.pdf |
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| ID | Term |
|---|---|
| D002181 | Candidiasis, Vulvovaginal |
| D014627 | Vaginitis |
| ID | Term |
|---|---|
| D002177 | Candidiasis |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D014848 | Vulvovaginitis |
| 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 |
|
| 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 |
|
| Unknown or Not Reported |
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| Bulgaria |
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