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

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

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.

Study Overview

• Status: Completed
• Conditions: Candida Vulvovaginitis
• Intervention / Treatment: Drug: Fluconazole; Drug: SCY-078

Detailed 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).

• Study Type: Interventional
• Enrollment (Actual): 186
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • UAB Personal Health Clinic
  • Arizona
    • Phoenix, Arizona, United States, 85032
      • Precision Trials AZ, LLC
  • California
    • San Diego, California, United States, 92111
      • Women's Health Care Research Corp.
  • Florida
    • Brandon, Florida, United States, 33510
      • Gulf Coast Research Group, LLC
    • Lake Worth, Florida, United States, 33461
      • Altus Research, Inc.
    • Leesburg, Florida, United States, 34748
      • OB-GYN Associates of Mid-Florida P.A.
    • Miami, Florida, United States, 33186
      • New Age Medical Research Corp.
    • South Miami, Florida, United States, 33160
      • Visionary Investigators Network
  • Georgia
    • Roswell, Georgia, United States, 30075
      • Atlanta North Gynecology, P.C.
  • Kansas
    • Wichita, Kansas, United States, 67226
      • Cypress Medical Research Center, LLC
  • Louisiana
    • Covington, Louisiana, United States, 70433
      • Clinical Trials Management, LLC
    • Metairie, Louisiana, United States, 70006
      • Clinical Trials Management, LLC
    • New Orleans, Louisiana, United States, 70125
      • Women Under Study, LLC
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Tolan Park Medical Building
  • Missouri
    • Saint Louis, Missouri, United States, 63131
      • Consultants in Women's Healthcare, Inc.
  • New Jersey
    • Lawrenceville, New Jersey, United States, 08648
      • Lawrence OB/GYN Clinical Research, LLC
    • Plainsboro, New Jersey, United States, 08536
      • Women's Health Research Center
  • North Carolina
    • Greensboro, North Carolina, United States, 27408
      • Unified Women's Clinical Research - Central Carolina
    • Raleigh, North Carolina, United States, 27612
      • Wake Research Associates, LLC
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19102
      • Drexel University
  • South Carolina
    • Charleston, South Carolina, United States, 29407
      • Medical Research South, LLC
  • Tennessee
    • Memphis, Tennessee, United States, 38120
      • WR-Medical Research Center of Memphis, LLC
  • Texas
    • Houston, Texas, United States, 77054
      • TMC Life Research, Inc.
    • San Antonio, Texas, United States, 78229
      • Clinical Trials of Texas, Inc.
  • Washington
    • Seattle, Washington, United States, 98105
      • Seattle Women's Health, Research, Gynecology

Participation Criteria

Eligibility Criteria

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

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Fluconazole; 150 mg/day for 1 day	Drug: Fluconazole; Oral Antifungal comparator; Other Names: Diflucan, Azole antifungal
Experimental: Ibrexafungerp 750mg; 750mg QD for 1 day only	Drug: SCY-078; Investigational Antifungal; Other Names: Ibrexafungerp
Experimental: Ibrexafungerp 300mg; 300mg BID for 1 day only	Drug: SCY-078; Investigational Antifungal; Other Names: Ibrexafungerp
Experimental: Ibrexafungerp 450mg; 450mg BID for 1 day only	Drug: SCY-078; Investigational Antifungal; Other Names: Ibrexafungerp
Experimental: Ibrexafungerp 150mg; 150mg BID for 3 days	Drug: SCY-078; Investigational Antifungal; Other Names: Ibrexafungerp
Experimental: Ibrexafungerp 300mg D1-D3; 300mg BID for 3 days	Drug: SCY-078; Investigational Antifungal; Other Names: Ibrexafungerp

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Treatment Emergent Adverse Events	The number of subjects with treatment related adverse events	up to 29 days

Collaborators and Investigators

• Sponsor: Scynexis, Inc.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2017
• Primary Completion (Actual): May 4, 2018
• Study Completion (Actual): May 4, 2018

Study Registration Dates

• First Submitted: July 14, 2017
• First Submitted That Met QC Criteria: August 16, 2017
• First Posted (Actual): August 17, 2017

Study Record Updates

• Last Update Posted (Actual): August 12, 2021
• Last Update Submitted That Met QC Criteria: August 11, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Bacterial Infections and Mycoses; Mycoses; Vaginal Diseases; Vulvar Diseases; Vaginitis; Vulvitis; Candidiasis; Vulvovaginitis; 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-078-204

Plan for Individual participant data (IPD)

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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No