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

Candida Vulvovaginitis Clinical Trial

— DOVE  

Official title:

A Phase 2, Multicenter, Randomized, Double-Blind, Double-Dummy, Active-Controlled, Dose-Finding Study to Compare the Safety and Efficacy of Oral Ibrexafungerp (SCY-078) vs. Oral Fluconazole in Subjects With Acute Vulvovaginal Candidiasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03253094
• Other study ID #: SCY-078-204
• Status: Completed
• Phase: Phase 2
• Start date: August 1, 2017
• Est. completion date: May 4, 2018

Study information

• Verified date: August 2021
• Source: Scynexis, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 186
• Est. completion date: May 4, 2018
• Est. primary completion date: May 4, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Key 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)

Key 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.

Related Conditions & MeSH terms

• Candida Vulvovaginitis
• Candidiasis
• Candidiasis, Vulvovaginal
• Vulvovaginitis

Intervention

Drug:
• Fluconazole
Oral Antifungal comparator
• SCY-078
Investigational Antifungal

Locations

Country	Name	City	State
United States	UAB Personal Health Clinic	Birmingham	Alabama
United States	Gulf Coast Research Group, LLC	Brandon	Florida
United States	Medical Research South, LLC	Charleston	South Carolina
United States	Clinical Trials Management, LLC	Covington	Louisiana
United States	Tolan Park Medical Building	Detroit	Michigan
United States	Unified Women's Clinical Research - Central Carolina	Greensboro	North Carolina
United States	Tmc Life Research, Inc.	Houston	Texas
United States	Altus Research, Inc.	Lake Worth	Florida
United States	Lawrence OB/GYN Clinical Research, LLC	Lawrenceville	New Jersey
United States	OB-GYN Associates of Mid-Florida P.A.	Leesburg	Florida
United States	WR-Medical Research Center of Memphis, LLC	Memphis	Tennessee
United States	Clinical Trials Management, LLC	Metairie	Louisiana
United States	New Age Medical Research Corp.	Miami	Florida
United States	Women Under Study, LLC	New Orleans	Louisiana
United States	Drexel University	Philadelphia	Pennsylvania
United States	Precision Trials AZ, LLC	Phoenix	Arizona
United States	Women's Health Research Center	Plainsboro	New Jersey
United States	Wake Research Associates, LLC	Raleigh	North Carolina
United States	Atlanta North Gynecology, P.C.	Roswell	Georgia
United States	Consultants in Women's Healthcare, Inc.	Saint Louis	Missouri
United States	Clinical Trials of Texas, Inc.	San Antonio	Texas
United States	Women's Health Care Research Corp.	San Diego	California
United States	Seattle Women's Health, Research, Gynecology	Seattle	Washington
United States	Visionary Investigators Network	South Miami	Florida
United States	Cypress Medical Research Center, LLC	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Scynexis, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of Treatment Emergent Adverse Events	The number of subjects with treatment related adverse events	up to 29 days
Primary	Clinical Cure (Complete Resolution of Signs and Symptoms)	Measured by the percentage of subjects with clinical cure (complete resolution of signs and symptoms) at the test-of-cure (TOC) visit	8-12 days
Secondary	Co-occurrence of Clinical and Mycological Cure	The percentage of subjects with both clinical cure and mycological eradication (negative fungal culture) the Test-of cure.	29 days