Study NCT03840616
Study of Oral Oteseconazole (VT-1161) for Acute Yeast Infections in Patients With Recurrent Yeast Infections (ultraVIOLET)
Submitted Date:  November 29, 2021 (v7)
Quality Control Review Has Not Concluded

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Open or close this module Study Identification
Unique Protocol ID: VMT-VT-1161-CL-017
Brief Title: Study of Oral Oteseconazole (VT-1161) for Acute Yeast Infections in Patients With Recurrent Yeast Infections (ultraVIOLET)
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
Secondary IDs:
Open or close this module Study Status
Record Verification: November 2021
Overall Status: Completed
Study Start: March 13, 2019
Primary Completion: December 2, 2020 [Actual]
Study Completion: December 2, 2020 [Actual]
First Submitted: February 11, 2019
First Submitted that
Met QC Criteria:
February 11, 2019
First Posted: February 15, 2019 [Actual]
Last Update Submitted that
Met QC Criteria:
Last Update Posted: December 28, 2021 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Mycovia Pharmaceuticals Inc.
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module Study Description
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:
Open or close this module Conditions
Conditions: Recurrent Vulvovaginal Candidiasis
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Triple (Participant, Care Provider, Investigator)
Allocation: Randomized
Enrollment: 219 [Actual]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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.
Open or close this module Outcome Measures
[See Results Section.]
Primary Outcome Measures:
1. 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)

Open or close this module Eligibility
Minimum Age: 12 Years
Maximum Age:
Sex: Female
Gender Based:
Accepts Healthy Volunteers: No
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
Open or close this module Contacts/Locations
Locations: United States, Arizona
34
Tucson, Arizona, United States, 85712
United States, California
39
Encino, California, United States, 91436
25
Los Angeles, California, United States, 90036
United States, Colorado
22
Englewood, Colorado, United States, 80112
United States, Florida
49
Boca Raton, Florida, United States, 33486
14
Gainesville, Florida, United States, 32607
13
Leesburg, Florida, United States, 34748
33
Loxahatchee Groves, Florida, United States, 33470
36
Miami, Florida, United States, 33155
United States, Georgia
17
Savannah, Georgia, United States, 31406
United States, Idaho
27
Idaho Falls, Idaho, United States, 83404
10
Nampa, Idaho, United States, 83687
United States, Illinois
62
Chicago, Illinois, United States, 60643
United States, Indiana
41
Fort Wayne, Indiana, United States, 46825
United States, Louisiana
30
Marrero, Louisiana, United States, 70072
United States, Michigan
50
Dearborn Heights, Michigan, United States, 48127
29
Saginaw, Michigan, United States, 48602
55
Traverse City, Michigan, United States, 49686
32
Troy, Michigan, United States, 48085
United States, Missouri
26
Kansas City, Missouri, United States, 64111
United States, New Jersey
42
New Brunswick, New Jersey, United States, 08901
47
Ocean City, New Jersey, United States, 07712
United States, North Carolina
37
Charlotte, North Carolina, United States, 28207
38
Fayetteville, North Carolina, United States, 28304
United States, Ohio
15
Columbus, Ohio, United States, 43213
United States, South Carolina
18
Bluffton, South Carolina, United States, 29910
48
Myrtle Beach, South Carolina, United States, 29572
United States, Tennessee
20
Bristol, Tennessee, United States, 37620
21
Murfreesboro, Tennessee, United States, 37130
United States, Texas
24
Austin, Texas, United States, 78705
23
Fort Worth, Texas, United States, 76104
63
Katy, Texas, United States, 77450
58
League City, Texas, United States, 77573
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:
Open or close this module Document Section
Study Protocol
Document Date: January 17, 2019
Uploaded: 11/29/2021 14:52
File Name: Prot_000.pdf
Statistical Analysis Plan
Document Date: December 21, 2020
Uploaded: 11/29/2021 14:52
File Name: SAP_001.pdf
Study Results
Open or close this module Participant Flow
Recruitment Details After providing consent, 251 subjects were screened and, of those, a total of 219 subjects were randomly assigned to the oteseconazole or fluconazole/placebo group for a 2-week induction phase. During the induction phase, subjects received either oteseconazole or fluconazole. Subjects whose presenting acute VVC episode resolved during the induction phase (a total of 185 subjects) entered a 48-week maintenance phase comprised of an 11-week treatment period and a 37-week follow-up period.
Pre-assignment Details
 
Arm/Group Title Oteseconazole (VT-1161) Fluconazole / Placebo
Arm/Group Description 600mg on Day 1 and 450mg on Day 2, followed by 150mg once weekly for 11 weeks starting on Day 14. 150mg fluconazole every 72 hours in 3 sequential doses starting on Day 1, followed by placebo once weekly for 11 weeks starting on Day 14.

Quality Control Review Comment provided by the National Library of Medicine:

  1. Information within the Participant Flow module appears inconsistent.
Period Title: Overall Study
Started 147 72
Completed 112 55
Not Completed 35 17
Open or close this module Baseline Characteristics
Arm/Group TitleOteseconazole (VT-1161)Fluconazole / PlaceboTotal
Arm/Group Description600mg on Day 1 and 450mg on Day 2, followed by 150mg once weekly for 11 weeks starting on Day 14.150mg fluconazole every 72 hours in 3 sequential doses starting on Day 1, followed by placebo once weekly for 11 weeks starting on Day 14.Total of all reporting groups
Overall Number of Baseline Participants 147 72 219
Baseline Analysis Population Description [Not Specified]
Age, Continuous
Mean (Standard Deviation)
Unit of measure: years
Number Analyzed147 Participants72 Participants219 Participants
34(10.7)36(11.7)35(11.0)
Sex: Female, Male
Measure Type: Count of Participants
Unit of measure: Participants
Number Analyzed147 Participants72 Participants219 Participants
Female
147
100%
72
100%
219
100%
Male
0
0%
0
0%
0
0%
Race (NIH/OMB)
Measure Type: Count of Participants
Unit of measure: Participants
Number Analyzed147 Participants72 Participants219 Participants
American Indian or Alaska Native
1
0.68%
1
1.39%
2
0.91%
Asian
3
2.04%
0
0%
3
1.37%
Native Hawaiian or Other Pacific Islander
0
0%
0
0%
0
0%
Black or African American
47
31.97%
27
37.5%
74
33.79%
White
88
59.86%
42
58.33%
130
59.36%
More than one race
7
4.76%
2
2.78%
9
4.11%
Unknown or Not Reported
1
0.68%
0
0%
1
0.46%
Region of Enrollment
Measure Type: Number
Unit of measure: participants
Number Analyzed147 Participants72 Participants219 Participants
United States
14772219
Open or close this module Outcome Measures
1. Primary Outcome:
Title 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
Description

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)

Time Frame 48 Weeks
Outcome Measure Data
Analysis Population Description
Analysis was performed on the ITT population which includes subjects who failed to clear their initial acute VVC episode during the induction phase. The ITT population was defined as all randomized subjects. Missing values were imputed with multiple imputation using the following auxiliary information: treatment, baseline body mass index, baseline age, ethnicity, and visit. The 'percentage of participants' measure represents an average of 10 individual tests using multiple imputation.
 
Arm/Group TitleOteseconazole (VT-1161)Fluconazole / Placebo
Arm/Group Description600mg on Day 1 and 450mg on Day 2, followed by 150mg once weekly for 11 weeks starting on Day 14.150mg fluconazole every 72 hours in 3 sequential doses starting on Day 1, followed by placebo once weekly for 11 weeks starting on Day 14.
Overall Number of Participants Analyzed147 72
Measure Type: Number
Unit of Measure: percentage of participants
5.1 42.2
Open or close this module Adverse Events
 
Time Frame Day 1 through Week 50
Adverse Event Reporting Description The safety population was defined as all randomized subjects who received at least 1 dose of investigational product. Treatment-emergent adverse events were defined as adverse events that occurred after the subject received her initial dose of investigational product.
 
Arm/Group Title Oteseconazole (VT-1161) Fluconazole / Placebo
Arm/Group Description 600mg on Day 1 and 450mg on Day 2, followed by 150mg once weekly for 11 weeks starting on Day 14. 150mg fluconazole every 72 hours in 3 sequential doses starting on Day 1, followed by placebo once weekly for 11 weeks starting on Day 14.

Quality Control Review Comment provided by the National Library of Medicine:

  1. The arms/groups appear inconsistent with information in other parts of the record. Each arm/group should be described separately, or a valid explanation provided.
All-Cause Mortality
  Oteseconazole (VT-1161)Fluconazole / Placebo
 Affected / At Risk (%)# Events Affected / At Risk (%)# Events
Total 1 / 146 (0.68%)0 / 72 (0%)
Serious Adverse Events
  Oteseconazole (VT-1161)Fluconazole / Placebo
 Affected / At Risk (%)# Events Affected / At Risk (%)# Events
Total 3 / 146 (2.05%)1 / 72 (1.39%)
Blood and lymphatic system disorders
Anaemia 1 / 146 (0.68%)10 / 72 (0%)0
Gastrointestinal disorders
Retroperitoneal haemorrhage 1 / 146 (0.68%)10 / 72 (0%)0
Infections and infestations
Appendicitis 1 / 146 (0.68%)10 / 72 (0%)0
Pneumonia 0 / 146 (0%)01 / 72 (1.39%)1
Pneumonia viral 1 / 146 (0.68%)10 / 72 (0%)0
Nervous system disorders
Cerebrovascular accident 1 / 146 (0.68%)10 / 72 (0%)0
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure 1 / 146 (0.68%)10 / 72 (0%)0
Pulmonary embolism 1 / 146 (0.68%)10 / 72 (0%)0
Vascular disorders
Deep vein thrombosis 1 / 146 (0.68%)10 / 72 (0%)0
Indicates events were collected by systematic assessment.
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
  Oteseconazole (VT-1161)Fluconazole / Placebo
 Affected / At Risk (%)# Events Affected / At Risk (%)# Events
Total 79 / 146 (54.11%)46 / 72 (63.89%)
Gastrointestinal disorders
Diarrhoea 1 / 146 (0.68%)14 / 72 (5.56%)4
Nausea 7 / 146 (4.79%)82 / 72 (2.78%)2
Vomiting 2 / 146 (1.37%)22 / 72 (2.78%)2
General disorders
Fatigue 4 / 146 (2.74%)41 / 72 (1.39%)1
Pyrexia 7 / 146 (4.79%)83 / 72 (4.17%)5
Infections and infestations
Bacterial vaginosis 16 / 146 (10.96%)2511 / 72 (15.28%)17
Bronchitis 1 / 146 (0.68%)12 / 72 (2.78%)2
Corona virus infection 1 / 146 (0.68%)12 / 72 (2.78%)2
Fungal infection 2 / 146 (1.37%)33 / 72 (4.17%)5
Influenza 3 / 146 (2.05%)33 / 72 (4.17%)3
Lower respiratory tract infection 0 / 146 (0%)02 / 72 (2.78%)2
Nasopharyngitis 3 / 146 (2.05%)31 / 72 (1.39%)1
Pharyngitis streptococcal 3 / 146 (2.05%)31 / 72 (1.39%)1
Sinusitis 2 / 146 (1.37%)23 / 72 (4.17%)4
Upper respiratory tract infection 7 / 146 (4.79%)82 / 72 (2.78%)2
Urinary tract infection 18 / 146 (12.33%)2212 / 72 (16.67%)14
Vulvovaginal candidiasis 1 / 146 (0.68%)12 / 72 (2.78%)2
Injury, poisoning and procedural complications
Ligament sprain 0 / 146 (0%)02 / 72 (2.78%)3
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain 0 / 146 (0%)02 / 72 (2.78%)2
Nervous system disorders
Headache 8 / 146 (5.48%)96 / 72 (8.33%)12
Reproductive system and breast disorders
Vulvovaginal pruritus 1 / 146 (0.68%)13 / 72 (4.17%)3
Respiratory, thoracic and mediastinal disorders
Cough 0 / 146 (0%)03 / 72 (4.17%)3
Skin and subcutaneous tissue disorders
Rash 4 / 146 (2.74%)41 / 72 (1.39%)1
Indicates events were collected by systematic assessment.
Open or close this module Limitations and Caveats
[Not specified]
Open or close this module More Information
Certain Agreements:
Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between the Principal Investigator and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Neither institution nor investigator can disclose information pertaining to study until sponsor issues multi-center publication. If multi-center publication is not issued within 18 months of study completion and database lock at all sites, sponsor has 30 days from receipt to review institution's and/or investigator's communication and can require removal of confidential information other than study data and/or delay release of institution's and/or investigator's communication for 60 days.
Results Point of Contact:
Name/Official Title:
Clinical Trial Administration
Organization:
Mycovia Pharmaceuticals Inc
Phone:
919-467-8539
Email:
adminops@mycovia.com

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