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

Primary Purpose

Vulvovaginal Candidiasis

Status

Completed

Phase

Phase 2

Locations

Dominican Republic

Study Type

Interventional

Intervention

SCY-078

Fluconazole

About this trial

This is an interventional treatment trial for Vulvovaginal Candidiasis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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:
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.

Sites / Locations

Hospital Dr. Francisco E. Moscoso Puello
Instituto Dermatologico y Cirugia de Piel

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Arm Label

Treatment Group 1 (Fluconazole)

Treatment Group 2: (SCY-078)

Treatment Group 3 (SCY-078)

Arm Description

Fluconazole

Dose regimen 1

Dose regimen 2

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT02679456

First Posted

January 19, 2016

Last Updated

July 10, 2019

Sponsor

Scynexis, Inc.

Collaborators

ethica Clinical Research Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02679456

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2019

Overall Recruitment Status

Completed

Study Start Date

November 2015 (undefined)

Primary Completion Date

August 5, 2016 (Actual)

Study Completion Date

August 5, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Scynexis, Inc.

Collaborators

ethica Clinical Research Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Vulvovaginal Candidiasis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

96 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment Group 1 (Fluconazole)

Arm Type

Active Comparator

Arm Description

Fluconazole

Arm Title

Treatment Group 2: (SCY-078)

Arm Type

Experimental

Arm Description

Dose regimen 1

Arm Title

Treatment Group 3 (SCY-078)

Arm Type

Experimental

Arm Description

Dose regimen 2

Intervention Type

Drug

Intervention Name(s)

SCY-078

Intervention Type

Drug

Intervention Name(s)

Fluconazole

Primary Outcome Measure Information:

Title

Proportion of subjects achieving therapeutic cure at the test of cure visit (Day 24 +/-3)

Description

Therapeutic Cure defined as achieving both a Clinical Cure (resolution of signs and symptoms) and a Mycological Eradication (negative culture).

Time Frame

Day 24 +/- 3

Secondary Outcome Measure Information:

Title

Proportion of subjects with recurrence of VVC during the observation period

Description

Recurrence defined as a symptomatic and culture-verified episode of VVC after achieving Therapeutic Cure.

Time Frame

4-month observation period

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David Angulo, MD

Organizational Affiliation

Scynexis, Inc.

Official's Role

Study Director

Facility Information:

Facility Name

Hospital Dr. Francisco E. Moscoso Puello

City

Santo Domingo

Country

Dominican Republic

Facility Name

Instituto Dermatologico y Cirugia de Piel

City

Santo Domingo

Country

Dominican Republic

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

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

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