A Study of Oral Oteseconazole (VT-1161) for the Treatment of Patients With Recurrent Vaginal Candidiasis (Yeast Infection)

Study Overview
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Brief Summary
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Recurrent vulvovaginal candidiasis (RVVC), also known as recurrent yeast infections, is defined as at least 3 episodes of acute VVC in the past 12 months. Several properties of oteseconazole (VT-1161) suggest that it might be a safer and more effective treatment for RVVC than other oral antifungal medicines. This study will evaluate the effectiveness and safety of oteseconazole (VT-1161) for the treatment of RVVC and consists of 2 parts. The first part of the study is a 2-week period for the treatment of the patient's current VVC episode with 3 150mg doses of fluconazole. The 2nd part consists of 12 weeks, when the patient will take either oteseconazole (VT-1161) 150 mg or a placebo (according to a random assignment), and then a 36-week follow-up period. In addition, at participating sites, an amendment to the study allows US patients who complete the initial 48 weeks without experiencing a confirmed RVVC episode to continue in a 48-week observational extension period designed to evaluate the continued effectiveness of oteseconazole (VT-1161). This study is identical to VMT-VT-1161-CL-011.

Official Title
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A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oteseconazole (VT-1161) Oral Capsules in the Treatment of Subjects With Recurrent Vulvovaginal Candidiasis

Conditions
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Recurrent Vulvovaginal Candidiasis

Intervention / Treatment
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* Drug: Oteseconazole (VT-1161)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: 3 or more episodes of acute VVC in the past 12 months Positive KOH or Gram stain test Total vulvovaginal signs and symptoms score of ≥3 at screening visit Total vulvovaginal signs and symptoms score of <3 at baseline visit Must be able to swallow pills Key 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

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oteseconazole (VT-1161) 150mg capsule<br>Once daily for 7 days starting at Day 1, followed by once weekly for 11 weeks | Drug: Oteseconazole (VT-1161)<br>* Oteseconazole (VT-1161) 150mg capsule<br>|
| Placebo Comparator: Placebo capsule<br>Once daily for 7 days starting at Day 1, followed by once weekly for 11 weeks | Drug: Placebo<br>* matching placebo capsule<br>|

What is the study measuring?
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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. 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) | Maintenance phase (post-randomization through Week 48) |