Safety and Efficacy of Oral Ibrexafungerp (SCY-078) vs. Oral Fluconazole in Subjects With Vulvovaginal Candidiasis
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Detailed Description
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
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Treatment Group 1 (Fluconazole) Fluconazole |
Drug: Fluconazole
|
| Experimental: Treatment Group 2: (SCY-078) Dose regimen 1 |
Drug: SCY-078
|
| Experimental: Treatment Group 3 (SCY-078) Dose regimen 2 |
Drug: SCY-078
|
Outcome Measures
Primary Outcome Measures
- Proportion of subjects achieving therapeutic cure at the test of cure visit (Day 24 +/-3) [Day 24 +/- 3]
Therapeutic Cure defined as achieving both a Clinical Cure (resolution of signs and symptoms) and a Mycological Eradication (negative culture).
Secondary Outcome Measures
- Proportion of subjects with recurrence of VVC during the observation period [4-month observation period]
Recurrence defined as a symptomatic and culture-verified episode of VVC after achieving Therapeutic Cure.
Eligibility Criteria
Criteria
Inclusion Criteria:
Subjects must fulfill all of the following criteria to be eligible for study admission:
-
Female subjects from 18 to 65 years of age in good general health
-
Diagnosis of symptomatic moderate to severe vulvovaginal candidiasis
-
The ability to understand and sign a written informed consent form (ICF), which must be obtained prior to treatment and any study-related procedures.
-
The ability to understand and sign a consent or authorization form which shall permit the use, disclosure and transfer of the subject's personal health information (e.g., in the U.S. HIPAA Authorization form).
-
The ability to understand and follow all study-related procedures including study drug administration.
-
Females of childbearing potential must agree to use a medically acceptable method of contraception while receiving protocol-assigned product.
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:
- 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.
- HIV infection, chemotherapy or illness serious enough to induce an immune deficiency.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hospital Dr. Francisco E. Moscoso Puello | Santo Domingo | Dominican Republic | ||
| 2 | Instituto Dermatologico y Cirugia de Piel | Santo Domingo | Dominican Republic |
Sponsors and Collaborators
- Scynexis, Inc.
- ethica Clinical Research Inc.
Investigators
- Study Director: David Angulo, MD, Scynexis, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SCY-078-203