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

NCT ID: NCT02679456

Last Updated: 2019-07-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2016-08-05

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.

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

Conditions

Vulvovaginal Candidiasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Treatment Group 1 (Fluconazole)

Fluconazole

Group Type: ACTIVE_COMPARATOR

Fluconazole

Intervention Type: DRUG

Treatment Group 2: (SCY-078)

Dose regimen 1

Group Type: EXPERIMENTAL

SCY-078

Intervention Type: DRUG

Treatment Group 3 (SCY-078)

Dose regimen 2

Group Type: EXPERIMENTAL

SCY-078

Intervention Type: DRUG

Interventions

SCY-078

Intervention Type: DRUG

Fluconazole

Intervention Type: DRUG

Eligibility Criteria

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

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

ethica Clinical Research Inc.

INDUSTRY

Sponsor Role: collaborator

Scynexis, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Angulo, MD

Role: STUDY_DIRECTOR

Scynexis, Inc.

Locations

Hospital Dr. Francisco E. Moscoso Puello

Santo Domingo, , Dominican Republic

Instituto Dermatologico y Cirugia de Piel

Santo Domingo, , Dominican Republic

Countries

Dominican Republic

Other Identifiers

SCY-078-203

Identifier Type: -

Identifier Source: org_study_id