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

• ClinicalTrials.gov Identifier: NCT03840616
• Recruitment Status: Completed
• First Posted: February 15, 2019
• Results First Posted: February 4, 2022
• Last Update Posted: February 4, 2022
• Sponsor: Mycovia Pharmaceuticals Inc.
• Information provided by (Responsible Party): Mycovia Pharmaceuticals Inc.

Tracking Information

• First Submitted Date: February 11, 2019
• First Posted Date: February 15, 2019
• Results First Submitted Date: November 29, 2021
• Results First Posted Date: February 4, 2022
• Last Update Posted Date: February 4, 2022
• Actual Study Start Date: March 13, 2019
• Actual Primary Completion Date: December 2, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 29, 2021)

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 [ Time Frame: 48 Weeks ]

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)

Original Primary Outcome Measures (submitted: February 11, 2019)

Percentage of subjects with one or more culture-verified acute VVC episodes [ Time Frame: 50 Weeks ]

An acute VVC episode (considered a recurrent episode) is defined as a positive culture for Candida species and a clinical signs and symptoms score of ≥3. Outcome measure includes subjects who failed clearing their initial acute VVC episode during Part 1.

• Current Secondary Outcome Measures: Not Provided

Original Secondary Outcome Measures (submitted: February 11, 2019)

Percentage of subjects with resolved acute VVC episodes during Part 1 [ Time Frame: 14 Days ]

Resolution of the acute VVC episode is defined as a clinical signs and symptoms score of <3 at Day 14.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Study of Oral Oteseconazole (VT-1161) for Acute Yeast Infections in Patients With Recurrent Yeast Infections
• Official Title: 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

Brief Summary

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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment
• Condition: Recurrent Vulvovaginal Candidiasis

Intervention

• 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.
• 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.

Study Arms

• 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
  Intervention: Drug: Oteseconazole (VT-1161) 150mg capsule
• 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
  Interventions:

  • Drug: Fluconazole 150mg capsule
  • Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 24, 2021): 219
• Original Estimated Enrollment (submitted: February 11, 2019): 180
• Actual Study Completion Date: December 2, 2020
• Actual Primary Completion Date: December 2, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 12 Years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03840616
• Other Study ID Numbers: VMT-VT-1161-CL-017
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Responsible Party: Mycovia Pharmaceuticals Inc.
• Study Sponsor: Mycovia Pharmaceuticals Inc.
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Mycovia Pharmaceuticals Inc.
• Verification Date: November 2021