Safety and Efficacy of Oral Ibrexafungerp (SCY-078) vs. Oral Fluconazole in Subjects With Vulvovaginal Candidiasis

A Multicenter, Randomized, Evaluator Blinded, Active-Controlled Study to Evaluate the Safety and Efficacy of Oral Ibrexafungerp (SCY-078) vs. Oral Fluconazole in Subjects With Vulvovaginal Candidiasis

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.

Study Overview

• Status: Completed
• Conditions: Vulvovaginal Candidiasis
• Intervention / Treatment: Drug: Fluconazole; Drug: SCY-078

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 Type: Interventional
• Enrollment (Actual): 96
• Phase: Phase 2

Contacts and Locations

Study Locations

• Dominican Republic
  • Santo Domingo, Dominican Republic
    • Instituto Dermatologico y Cirugia de Piel
  • Santo Domingo, Dominican Republic
    • Hospital Dr. Francisco E. Moscoso Puello

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

Subjects must fulfill all of the following criteria to be eligible for study admission:

1. Female subjects from 18 to 65 years of age in good general health
2. Diagnosis of symptomatic moderate to severe vulvovaginal candidiasis
3. The ability to understand and sign a written informed consent form (ICF), which must be obtained prior to treatment and any study-related procedures.
4. 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).
5. The ability to understand and follow all study-related procedures including study drug administration.
6. 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:

1. Any vaginal condition other than VVC that may interfere with the diagnosis or evaluation of response to therapy.

2. 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.

3. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Scynexis, Inc.
• Collaborators: ethica Clinical Research Inc.

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Actual): August 5, 2016
• Study Completion (Actual): August 5, 2016

Study Registration Dates

• First Submitted: January 19, 2016
• First Submitted That Met QC Criteria: February 6, 2016
• First Posted (Estimate): February 10, 2016

Study Record Updates

• Last Update Posted (Actual): July 12, 2019
• Last Update Submitted That Met QC Criteria: July 10, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Bacterial Infections and Mycoses; Mycoses; Vaginal Diseases; Vulvar Diseases; Vaginitis; Vulvitis; Vulvovaginitis; Candidiasis; Candidiasis, Vulvovaginal; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Cytochrome P-450 Enzyme Inhibitors; Hormone Antagonists; Antifungal Agents; Steroid Synthesis Inhibitors; 14-alpha Demethylase Inhibitors; Cytochrome P-450 CYP2C9 Inhibitors; Cytochrome P-450 CYP2C19 Inhibitors; Fluconazole; Ibrexafungerp
• Other Study ID Numbers: SCY-078-203

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided