Recurrent Vulvovaginal Candidiasis
Conditions
Brief summary
VT-1161 is a novel, oral inhibitor of fungal lanosterol demethylase (CYP51). In vitro and in vivo pharmacology studies have demonstrated that VT-1161 is highly active against Candida albicans and also non-albicans Candida species that cause vulvovaginal candidiasis. VT-1161 is highly selective for fungal CYP51, and data suggests that it may avoid the side-effect profile that limits the use of commonly prescribed antifungal agents for the treatment of recurrent yeast infections.
Interventions
DRUGVT-1161
DRUGPlacebo
Sponsors
Viamet
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: Clinical diagnosis of symptomatic acute VVC 3 or more episodes of acute VVC in the past 12 months Positive KOH Minimum composite vulvovaginal signs and symptoms score of ≥3 at Screening Composite vulvovaginal signs and symptoms score of \<3 at Baseline Must be able to swallow tablets Key
Exclusion criteria
Evidence of major organ system disease Presence or a history of another vaginal or vulvar condition(s) History of cervical cancer Poorly controlled diabetes mellitus Pregnant Recent use of topical or systemic antifungal drugs Recent use of immunosuppressive or system corticosteroid therapies
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Percentage of Subjects With 1 or More Culture-verified Acute VVC Episodes Through Week 48 of the Study in the Intent-to-treat Population. | 48 Weeks | A culture-verified acute VVC episode was defined as a positive fungal culture for Candida species associated with 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 higher scores indicating a worse outcome. 0 = none (complete absence of any sign or symptom) 1. = mild (slight) 2. = moderate (definitely present) 3. = severe (marked, intense) |
Countries
United States
Participant flow
Pre-assignment details
A total of 254 subjects were enrolled in the 14-day open-label Induction Phase of the study after providing consent. Those subjects whose acute VVC infections resolved during the Induction Phase (a total of 215) entered the Maintenance Phase of the study.
Participants by arm
| Arm | Count |
|---|---|
| VT-1161 Low-dose 3-month 1 VT-1161 150mg tablet and 1 placebo tablet once daily for 7 days, then once weekly for 11 weeks, followed by 2 placebo tablet once weekly for 12 weeks | 42 |
| VT-1161 Low-dose 6-month 1 VT-1161 150mg tablet and 1 placebo tablet once daily for 7 days, then once weekly for 23 weeks | 43 |
| VT-1161 High-dose 3-month 2 VT-1161 150mg tablets once daily for 7 days, then once weekly for 11 weeks, followed by 2 placebo tablet once weekly for 12 weeks | 43 |
| VT-1161 High-dose 24-week 2 VT-1161 150mg tablets once daily for 7 days, then once weekly for 23 weeks | 41 |
| Placebo 2 placebo tablets once daily for 7 days, then once weekly for 23 weeks | 46 |
| Total | 215 |
Baseline characteristics
| Characteristic | VT-1161 Low-dose 3-month | VT-1161 Low-dose 6-month | VT-1161 High-dose 3-month | VT-1161 High-dose 24-week | Placebo | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 35.0 years STANDARD_DEVIATION 10.2 | 34.6 years STANDARD_DEVIATION 9.09 | 34.2 years STANDARD_DEVIATION 9.28 | 33.8 years STANDARD_DEVIATION 10.13 | 35.4 years STANDARD_DEVIATION 11.2 | 34.6 years STANDARD_DEVIATION 9.95 |
| Sex: Female, Male Female | 42 Participants | 43 Participants | 43 Participants | 41 Participants | 46 Participants | 215 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 26 / 41 | 31 / 42 | 30 / 42 | 28 / 41 | 35 / 45 |
| serious Total, serious adverse events | 1 / 41 | 0 / 42 | 1 / 42 | 2 / 41 | 1 / 45 |
Outcome results
Primary
The Percentage of Subjects With 1 or More Culture-verified Acute VVC Episodes Through Week 48 of the Study in the Intent-to-treat Population.
A culture-verified acute VVC episode was defined as a positive fungal culture for Candida species associated with 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 higher scores 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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| VT-1161 Low-dose 3-month | The Percentage of Subjects With 1 or More Culture-verified Acute VVC Episodes Through Week 48 of the Study in the Intent-to-treat Population. | 2 Participants |
| VT-1161 Low-dose 6-month | The Percentage of Subjects With 1 or More Culture-verified Acute VVC Episodes Through Week 48 of the Study in the Intent-to-treat Population. | 3 Participants |
| VT-1161 High-dose 3-month | The Percentage of Subjects With 1 or More Culture-verified Acute VVC Episodes Through Week 48 of the Study in the Intent-to-treat Population. | 0 Participants |
| VT-1161 High-dose 24-week | The Percentage of Subjects With 1 or More Culture-verified Acute VVC Episodes Through Week 48 of the Study in the Intent-to-treat Population. | 2 Participants |
| Placebo | The Percentage of Subjects With 1 or More Culture-verified Acute VVC Episodes Through Week 48 of the Study in the Intent-to-treat Population. | 24 Participants |