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Dose-Finding Study of Oral Ibrexafungep (SCY-078) vs. Oral Fluconazole in Subjects With Acute Vulvovaginal Candidiasis

NCT ID: NCT03253094

Last Updated: 2021-08-12

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

186 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-01

Study Completion Date

2018-05-04

Brief Summary

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This is a multicenter, randomized, double-blind, double-dummy, active-controlled, dose-finding study to compare the efficacy, safety and tolerability of oral SCY-078 versus oral fluconazole in adult female subjects 18 years and older with moderate to severe Acute Vulvovaginal Candidiasis (AVVC). Approximately 180 eligible subjects (30 subjects per treatment group) will be enrolled and randomized into the study.

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Detailed Description

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This is a Phase 2, multicenter, randomized, double-blind, double-dummy, active-controlled, dose-ranging study of female subjects with moderate to severe Acute Vulvovaginal Candidiasis. Subjects will be randomized to either the investigational arm (SCY-078) with 5 different dose regiments ranging from 1 to 3 days of treatment or to the active-control arm (fluconazole) for 1 day of treatment. After randomization subjects may be seen on study Day 3 (on site visit for PK subjects) , Day 10 (±2,) and Day 25 (+4).

Conditions

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Candida Vulvovaginitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized, double-blind, double-dummy, active-controlled, dose-finding
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Fluconazole

150 mg/day for 1 day

Group Type ACTIVE_COMPARATOR

Fluconazole

Intervention Type DRUG

Oral Antifungal comparator

Ibrexafungerp 750mg

750mg QD for 1 day only

Group Type EXPERIMENTAL

SCY-078

Intervention Type DRUG

Investigational Antifungal

Ibrexafungerp 300mg

300mg BID for 1 day only

Group Type EXPERIMENTAL

SCY-078

Intervention Type DRUG

Investigational Antifungal

Ibrexafungerp 450mg

450mg BID for 1 day only

Group Type EXPERIMENTAL

SCY-078

Intervention Type DRUG

Investigational Antifungal

Ibrexafungerp 150mg

150mg BID for 3 days

Group Type EXPERIMENTAL

SCY-078

Intervention Type DRUG

Investigational Antifungal

Ibrexafungerp 300mg D1-D3

300mg BID for 3 days

Group Type EXPERIMENTAL

SCY-078

Intervention Type DRUG

Investigational Antifungal

Interventions

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Fluconazole

Oral Antifungal comparator

Intervention Type DRUG

SCY-078

Investigational Antifungal

Intervention Type DRUG

Other Intervention Names

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Diflucan, Azole antifungal Ibrexafungerp

Eligibility Criteria

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Inclusion Criteria

1. Subject is a female of at least 18 years of age
2. Subject has a diagnosis of symptomatic AVVC at baseline including a positive microscopic examination with 10% KOH in a vaginal sample revealing yeast forms (hyphae/pseudohyphae) or budding yeasts, and vaginal pH (≤4.5)

Exclusion Criteria

1. Subject has any vaginal condition other than AVVC that may interfere with the diagnosis or evaluation of response to therapy, such as suspected or confirmed concurrent causes of vulvovaginitis and/or cervicitis (mixed infection)
2. Need for systemic and/or topical (vaginal) antifungal treatment, including prescription or over-the-counter products during the study and treatment for VVC 28 days prior to randomization
3. Subject is actively menstruating at the time of the Baseline visit.
4. Subject has uncontrolled diabetes mellitus.
5. Subject has a vaginal sample with pH \>4.5.
6. Subject has a history of or an active cervical/vaginal cancer.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Scynexis, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David Angulo, MD

Role: STUDY_DIRECTOR

Scynexis, Inc.

Locations

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UAB Personal Health Clinic

Birmingham, Alabama, United States

Site Status

Precision Trials AZ, LLC

Phoenix, Arizona, United States

Site Status

Women's Health Care Research Corp.

San Diego, California, United States

Site Status

Gulf Coast Research Group, LLC

Brandon, Florida, United States

Site Status

Altus Research, Inc.

Lake Worth, Florida, United States

Site Status

OB-GYN Associates of Mid-Florida P.A.

Leesburg, Florida, United States

Site Status

New Age Medical Research Corp.

Miami, Florida, United States

Site Status

Visionary Investigators Network

South Miami, Florida, United States

Site Status

Atlanta North Gynecology, P.C.

Roswell, Georgia, United States

Site Status

Cypress Medical Research Center, LLC

Wichita, Kansas, United States

Site Status

Clinical Trials Management, LLC

Covington, Louisiana, United States

Site Status

Clinical Trials Management, LLC

Metairie, Louisiana, United States

Site Status

Women Under Study, LLC

New Orleans, Louisiana, United States

Site Status

Tolan Park Medical Building

Detroit, Michigan, United States

Site Status

Consultants in Women's Healthcare, Inc.

St Louis, Missouri, United States

Site Status

Lawrence OB/GYN Clinical Research, LLC

Lawrenceville, New Jersey, United States

Site Status

Women's Health Research Center

Plainsboro, New Jersey, United States

Site Status

Unified Women's Clinical Research - Central Carolina

Greensboro, North Carolina, United States

Site Status

Wake Research Associates, LLC

Raleigh, North Carolina, United States

Site Status

Drexel University

Philadelphia, Pennsylvania, United States

Site Status

Medical Research South, LLC

Charleston, South Carolina, United States

Site Status

WR-Medical Research Center of Memphis, LLC

Memphis, Tennessee, United States

Site Status

Tmc Life Research, Inc.

Houston, Texas, United States

Site Status

Clinical Trials of Texas, Inc.

San Antonio, Texas, United States

Site Status

Seattle Women's Health, Research, Gynecology

Seattle, Washington, United States

Site Status

Countries

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United States

References

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Nyirjesy P, Schwebke JR, Angulo DA, Harriott IA, Azie NE, Sobel JD. Phase 2 Randomized Study of Oral Ibrexafungerp Versus Fluconazole in Vulvovaginal Candidiasis. Clin Infect Dis. 2022 Jul 6;74(12):2129-2135. doi: 10.1093/cid/ciab841.

Reference Type DERIVED
PMID: 34555149 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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SCY-078-204

Identifier Type: -

Identifier Source: org_study_id

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