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| Name | Class |
|---|---|
| ethica Clinical Research Inc. | INDUSTRY |
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This is a randomized, multicenter, evaluator blinded study to evaluate the safety, tolerability, efficacy and pharmacokinetics of SCY-078 compared to Fluconazole in adult patients with moderate to severe Vulvovaginal Candidiasis (VVC) and a history of frequent episodes of VVC. Approximately 90 subjects, meeting the inclusion criteria will be enrolled and randomized in a 1:1:1 ratio to one of the 3 treatment arms: Oral SCY-078 in 2 dose regimens or oral Fluconazole. After enrollment, subjects will be evaluated on Day-5 (end of treatment visit), Day-24 (test of cure visit), Day-60, Day 90 and Day 120 (end of observation period visit) or at any time that a recurrence or clinical failure is suspected, up to the end of observation period.
This is a randomized, multicenter, evaluator blinded study to evaluate the safety, tolerability, efficacy and pharmacokinetics of SCY-078 compared to Fluconazole in adult patients, from 18 to 65 years of age, with moderate to severe Vulvovaginal Candidiasis (VVC) and a history of frequent episodes of VVC. Approximately 90 subjects, meeting the inclusion criteria will be enrolled and randomized in a 1:1:1 ratio to one of the 3 treatment arms: oral SCY-078 does regimen 1, or oral SCY-078 does regimen 2, or oral Fluconazole. After enrollment, subjects will be evaluated on Day-5 (end of treatment visit), Day-24 (test of cure visit), Day-60, Day 90 and Day 120 (end of observation period visit) or at any time that a recurrence or clinical failure is suspected, up to the end of observation period.
Primary Objectives:
* To evaluate the safety and efficacy of 2 dosing regimens of Oral SCY-078 in subjects with moderate to severe Vulvovaginal Candidiasis (VVC)
Secondary Objectives:
* To estimate the effect of Oral SCY-078 therapy in the rate and time to recurrence in subjects with a history of frequent episodes of VVC
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group 1 (Fluconazole) | Active Comparator | Fluconazole |
|
| Treatment Group 2: (SCY-078) | Experimental | Dose regimen 1 |
|
| Treatment Group 3 (SCY-078) | Experimental | Dose regimen 2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SCY-078 | Drug |
| ||
| Fluconazole |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects achieving therapeutic cure at the test of cure visit (Day 24 +/-3) | Therapeutic Cure defined as achieving both a Clinical Cure (resolution of signs and symptoms) and a Mycological Eradication (negative culture). | Day 24 +/- 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects with recurrence of VVC during the observation period | Recurrence defined as a symptomatic and culture-verified episode of VVC after achieving Therapeutic Cure. | 4-month observation period |
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Inclusion Criteria:
Subjects must fulfill all of the following criteria to be eligible for study admission:
Exclusion Criteria:
A subject will be excluded from participation in the study if she meets any of the following exclusion criteria:
Any vaginal condition other than VVC that may interfere with the diagnosis or evaluation of response to therapy.
Prior use of any prohibited medication(s) or procedure(s) within the protocol specified timeframe including:
a. Systemic and/or topical (vaginal) antifungal treatment, prescription or over the counter, within 30 days of the baseline visit.
Subjects with history of renal impairment, hepatic impairment or cervical cancer.
4 Subjects with known hypersensitivity to enfumafungin derivatives, fluconazole or any of the components of the formulation.
5. HIV infection, chemotherapy or illness serious enough to induce an immune deficiency.
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| Name | Affiliation | Role |
|---|---|---|
| David Angulo, MD | Scynexis, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Dr. Francisco E. Moscoso Puello | Santo Domingo | Dominican Republic | ||||
| Instituto Dermatologico y Cirugia de Piel |
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| ID | Term |
|---|---|
| D002181 | Candidiasis, Vulvovaginal |
| ID | Term |
|---|---|
| D002177 | Candidiasis |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C569338 | ibrexafungerp |
| D015725 | Fluconazole |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Drug |
|
| Santo Domingo |
| Dominican Republic |
| 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 |