Study of Oral Oteseconazole (VT-1161) for Acute Yeast Infections in Patients With Recurrent Yeast Infections (ultraVIOLET)

Phase 3, Randomized, Double-Blind Study to Evaluate Efficacy and Safety of Oteseconazole (VT-1161) Oral Capsules vs Fluconazole and Placebo in Treatment of Acute Vulvovaginal Candidiasis in Subjects With Recurrent Vulvovaginal Candidiasis

Recurrent vulvovaginal candidiasis (RVVC), also known as recurrent yeast infections, is defined as at least 3 episodes of acute vulvovaginal candidiasis (VVC) in the past 12 months. Several properties of oteseconazole (VT-1161) suggest it might be a safer and more effective treatment of RVVC than other oral antifungal medications.

This study will evaluate the effectiveness and safety of oteseconazole (VT-1161) for the treatment of acute VVC episodes in patients with RVVC and consists of 2 parts. The first part of the study is a 2-week induction phase for the treatment of the patient's current VVC episode when the patient will take either fluconazole or oteseconazole (VT-1161) according to a random assignment. The second part consists of an 11-week maintenance phase, when the patient will take either oteseconazole (VT-1161) or a placebo according to the random assignment from the first part of the study, and then a 37-week follow-up period.

Study Overview

• Status: Completed
• Conditions: Recurrent Vulvovaginal Candidiasis
• Intervention / Treatment: Drug: Oteseconazole (VT-1161) 150mg capsule; Drug: Fluconazole 150mg capsule; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 219
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85712
      • 34
  • California
    • Encino, California, United States, 91436
      • 39
    • Los Angeles, California, United States, 90036
      • 25
  • Colorado
    • Englewood, Colorado, United States, 80112
      • 22
  • Florida
    • Boca Raton, Florida, United States, 33486
      • 49
    • Gainesville, Florida, United States, 32607
      • 14
    • Leesburg, Florida, United States, 34748
      • 13
    • Loxahatchee Groves, Florida, United States, 33470
      • 33
    • Miami, Florida, United States, 33155
      • 36
  • Georgia
    • Savannah, Georgia, United States, 31406
      • 17
  • Idaho
    • Idaho Falls, Idaho, United States, 83404
      • 27
    • Nampa, Idaho, United States, 83687
      • 10
  • Illinois
    • Chicago, Illinois, United States, 60643
      • 62
  • Indiana
    • Fort Wayne, Indiana, United States, 46825
      • 41
  • Louisiana
    • Marrero, Louisiana, United States, 70072
      • 30
  • Michigan
    • Dearborn Heights, Michigan, United States, 48127
      • 50
    • Saginaw, Michigan, United States, 48602
      • 29
    • Traverse City, Michigan, United States, 49686
      • 55
    • Troy, Michigan, United States, 48085
      • 32
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • 26
  • New Jersey
    • New Brunswick, New Jersey, United States, 08901
      • 42
    • Ocean City, New Jersey, United States, 07712
      • 47
  • North Carolina
    • Charlotte, North Carolina, United States, 28207
      • 37
    • Fayetteville, North Carolina, United States, 28304
      • 38
  • Ohio
    • Columbus, Ohio, United States, 43213
      • 15
  • South Carolina
    • Bluffton, South Carolina, United States, 29910
      • 18
    • Myrtle Beach, South Carolina, United States, 29572
      • 48
  • Tennessee
    • Bristol, Tennessee, United States, 37620
      • 20
    • Murfreesboro, Tennessee, United States, 37130
      • 21
  • Texas
    • Austin, Texas, United States, 78705
      • 24
    • Fort Worth, Texas, United States, 76104
      • 23
    • Katy, Texas, United States, 77450
      • 63
    • League City, Texas, United States, 77573
      • 58

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• 3 or more episodes of acute VVC in the past 12 months
• Positive KOH test
• Total vulvovaginal signs and symptoms score of ≥3 at screening visit
• Total vulvovaginal signs and symptoms score of <3 at Day 14
• Must be able to swallow pills

Exclusion Criteria:

• Presence or a history of another vaginal or vulvar condition(s)
• Evidence of major organ system disease
• History of cervical cancer
• Poorly controlled diabetes mellitus
• Pregnant
• Recent use of topical or systemic antifungal or antibacterial drugs
• Recent use of immunosuppressive or systemic corticosteroid therapies

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oteseconazole (VT-1161) 150mg capsule; 600mg oteseconazole administered on Day 1 and 450mg administered on Day 2, followed by 150mg administered once weekly for 11 weeks staring on Day 14	Drug: Oteseconazole (VT-1161) 150mg capsule; 600mg administered on Day 1 and 450mg administered on Day 2, followed by 150mg administered once weekly for 11 weeks staring on Day 14.
Active Comparator: Fluconazole 150mg capsule / Placebo; 150mg fluconazole administered every 72 hours in 3 sequential doses starting on Day 1, followed by placebo administered once weekly starting on Day 14	Drug: Fluconazole 150mg capsule; 150mg administered every 72 hours in 3 sequential doses starting on Day 1.; Drug: Placebo; Administered once weekly starting on Day 14.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Subjects With 1 or More Culture-verified Acute VVC Episodes During the Maintenance Phase of the Study in the Intent-to-treat (ITT) Population	The primary efficacy outcome measure was the percentage of subjects with 1 or more culture-verified acute VVC episodes during the maintenance phase (post-randomization through Week 48) in the intent-to-treat population, which includes subjects who failed to clear their initial acute VVC episode during the induction phase. An acute VVC episode during the maintenance phase (considered a recurrent episode) was defined as a positive fungal culture for Candida species and a clinical signs and symptoms score of ≥3. To calculate the signs and symptoms score, each vulvovaginal sign (erythema, edema, excoriation) and symptom (itching, burning, irritation) was scored using the following scale, with a higher score indicating a worse outcome. 0 = none (complete absence of any sign or symptom), 1 = mild (slight), 2 = moderate (definitely present), 3 = severe (marked, intense)	48 Weeks

Collaborators and Investigators

• Sponsor: Mycovia Pharmaceuticals Inc.

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2019
• Primary Completion (Actual): December 2, 2020
• Study Completion (Actual): December 2, 2020

Study Registration Dates

• First Submitted: February 11, 2019
• First Submitted That Met QC Criteria: February 11, 2019
• First Posted (Actual): February 15, 2019

Study Record Updates

• Last Update Posted (Actual): February 4, 2022
• Last Update Submitted That Met QC Criteria: February 3, 2022
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Disease Attributes; Bacterial Infections and Mycoses; Mycoses; Vaginal Diseases; Vulvar Diseases; Vaginitis; Vulvitis; Vulvovaginitis; Candidiasis; Recurrence; 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
• Other Study ID Numbers: VMT-VT-1161-CL-017

Drug and device information, study documents

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