Trial Outcomes & Findings for A Study of Oral Oteseconazole (VT-1161) for the Treatment of Patients With Recurrent Vaginal Candidiasis (Yeast Infection) (NCT NCT03561701)

Last Updated: 2021-12-20

Results Overview

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)

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

425 participants

Primary outcome timeframe

Maintenance phase (post-randomization through Week 48)

Results posted on

2021-12-20

Participant Flow

A total of 425 subjects were enrolled in a 2-week Induction Phase after providing consent. During the Induction Phase, subjects received 3 sequential 150mg of fluconazole administered 72 hours apart. Subjects whose presenting acute VVC (vulvovaginal candidiasis) episode resolved during the Induction Phase (a total of 330) entered a 48-week Maintenance Phase comprised of a 12-week treatment period and a 36-week follow-up period.

Participant milestones

Participant milestones
Measure	Oteseconazole (VT-1161) 1 oteseconazole 150mg capsule once daily for 7 days starting at Day 1, then once weekly for 11 weeks	Placebo 1 placebo capsule once daily for 7 days starting at Day 1, then once weekly for 11 weeks
Overall Study STARTED	220	110
Overall Study COMPLETED	191	91
Overall Study NOT COMPLETED	29	19

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Oteseconazole (VT-1161) n=218 Participants 1 oteseconazole 150mg capsule once daily for 7 days starting at Day 1, then once weekly for 11 weeks	Placebo n=108 Participants 1 placebo capsule once daily for 7 days starting at Day 1, then once weekly for 11 weeks	Total n=326 Participants Total of all reporting groups
Age, Continuous	34 years STANDARD_DEVIATION 9.4 • n=5 Participants	36 years STANDARD_DEVIATION 10.8 • n=7 Participants	34 years STANDARD_DEVIATION 9.9 • n=5 Participants
Sex: Female, Male Female	218 Participants n=5 Participants	108 Participants n=7 Participants	326 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	23 Participants n=5 Participants	8 Participants n=7 Participants	31 Participants n=5 Participants
Race (NIH/OMB) White	193 Participants n=5 Participants	96 Participants n=7 Participants	289 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment Belgium	18 participants n=5 Participants	8 participants n=7 Participants	26 participants n=5 Participants
Region of Enrollment Czechia	51 participants n=5 Participants	22 participants n=7 Participants	73 participants n=5 Participants
Region of Enrollment Hungary	8 participants n=5 Participants	3 participants n=7 Participants	11 participants n=5 Participants
Region of Enrollment Romania	44 participants n=5 Participants	28 participants n=7 Participants	72 participants n=5 Participants
Region of Enrollment Ukraine	17 participants n=5 Participants	9 participants n=7 Participants	26 participants n=5 Participants
Region of Enrollment United States	80 participants n=5 Participants	38 participants n=7 Participants	118 participants n=5 Participants

PRIMARY outcome

Timeframe: Maintenance phase (post-randomization through Week 48)

Population: Analysis was performed on the ITT population which included all randomized subjects except the 4 excluded subjects. Missing values were imputed with multiple imputation using the following auxiliary information: region, treatment, baseline body mass index, baseline age, ethnicity, and visit.

Outcome measures

Outcome measures
Measure	Oteseconazole (VT-1161) n=218 Participants 1 oteseconazole150mg capsule once daily for 7 days starting at Day 1, then once weekly for 11 weeks	Placebo n=108 Participants 1 placebo capsule once daily for 7 days starting at Day 1, then once weekly for 11 weeks
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.	3.9 percentage of subjects	39.4 percentage of subjects

Adverse Events

Oteseconazole (VT-1161)

Serious events: 7 serious events

Other events: 112 other events

Deaths: 0 deaths

Placebo

Serious events: 5 serious events

Other events: 63 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Oteseconazole (VT-1161) n=217 participants at risk 1 oteseconazole 150mg capsule once daily for 7 days starting at Day 1, then once weekly for 11 weeks	Placebo n=110 participants at risk 1 placebo capsule once daily for 7 days starting at Day 1, then once weekly for 11 weeks
Infections and infestations Cholecystitis infective	0.46% 1/217 • Number of events 1 • Day 1 through Week 48 of the study The safety population was defined as all randomized subjects who received at least 1 dose of investigational product (3 subjects in the oteseconazole group did not receive investigational product). Treatment-emergent adverse events were defined as adverse events that occurred after the subject received her initial dose of investigational product.	0.00% 0/110 • Day 1 through Week 48 of the study The safety population was defined as all randomized subjects who received at least 1 dose of investigational product (3 subjects in the oteseconazole group did not receive investigational product). Treatment-emergent adverse events were defined as adverse events that occurred after the subject received her initial dose of investigational product.
Infections and infestations Pneumonia viral	0.00% 0/217 • Day 1 through Week 48 of the study The safety population was defined as all randomized subjects who received at least 1 dose of investigational product (3 subjects in the oteseconazole group did not receive investigational product). Treatment-emergent adverse events were defined as adverse events that occurred after the subject received her initial dose of investigational product.	0.91% 1/110 • Number of events 1 • Day 1 through Week 48 of the study The safety population was defined as all randomized subjects who received at least 1 dose of investigational product (3 subjects in the oteseconazole group did not receive investigational product). Treatment-emergent adverse events were defined as adverse events that occurred after the subject received her initial dose of investigational product.
Infections and infestations Severe acute respiratory syndrome	0.00% 0/217 • Day 1 through Week 48 of the study The safety population was defined as all randomized subjects who received at least 1 dose of investigational product (3 subjects in the oteseconazole group did not receive investigational product). Treatment-emergent adverse events were defined as adverse events that occurred after the subject received her initial dose of investigational product.	0.91% 1/110 • Number of events 1 • Day 1 through Week 48 of the study The safety population was defined as all randomized subjects who received at least 1 dose of investigational product (3 subjects in the oteseconazole group did not receive investigational product). Treatment-emergent adverse events were defined as adverse events that occurred after the subject received her initial dose of investigational product.
Infections and infestations Sinusitis	0.46% 1/217 • Number of events 1 • Day 1 through Week 48 of the study The safety population was defined as all randomized subjects who received at least 1 dose of investigational product (3 subjects in the oteseconazole group did not receive investigational product). Treatment-emergent adverse events were defined as adverse events that occurred after the subject received her initial dose of investigational product.	0.00% 0/110 • Day 1 through Week 48 of the study The safety population was defined as all randomized subjects who received at least 1 dose of investigational product (3 subjects in the oteseconazole group did not receive investigational product). Treatment-emergent adverse events were defined as adverse events that occurred after the subject received her initial dose of investigational product.
Musculoskeletal and connective tissue disorders Arthralgia	0.46% 1/217 • Number of events 1 • Day 1 through Week 48 of the study The safety population was defined as all randomized subjects who received at least 1 dose of investigational product (3 subjects in the oteseconazole group did not receive investigational product). Treatment-emergent adverse events were defined as adverse events that occurred after the subject received her initial dose of investigational product.	0.00% 0/110 • Day 1 through Week 48 of the study The safety population was defined as all randomized subjects who received at least 1 dose of investigational product (3 subjects in the oteseconazole group did not receive investigational product). Treatment-emergent adverse events were defined as adverse events that occurred after the subject received her initial dose of investigational product.
Musculoskeletal and connective tissue disorders Back pain	0.46% 1/217 • Number of events 1 • Day 1 through Week 48 of the study The safety population was defined as all randomized subjects who received at least 1 dose of investigational product (3 subjects in the oteseconazole group did not receive investigational product). Treatment-emergent adverse events were defined as adverse events that occurred after the subject received her initial dose of investigational product.	0.00% 0/110 • Day 1 through Week 48 of the study The safety population was defined as all randomized subjects who received at least 1 dose of investigational product (3 subjects in the oteseconazole group did not receive investigational product). Treatment-emergent adverse events were defined as adverse events that occurred after the subject received her initial dose of investigational product.
Cardiac disorders Myocarditis	0.00% 0/217 • Day 1 through Week 48 of the study The safety population was defined as all randomized subjects who received at least 1 dose of investigational product (3 subjects in the oteseconazole group did not receive investigational product). Treatment-emergent adverse events were defined as adverse events that occurred after the subject received her initial dose of investigational product.	0.91% 1/110 • Number of events 1 • Day 1 through Week 48 of the study The safety population was defined as all randomized subjects who received at least 1 dose of investigational product (3 subjects in the oteseconazole group did not receive investigational product). Treatment-emergent adverse events were defined as adverse events that occurred after the subject received her initial dose of investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer female	0.00% 0/217 • Day 1 through Week 48 of the study The safety population was defined as all randomized subjects who received at least 1 dose of investigational product (3 subjects in the oteseconazole group did not receive investigational product). Treatment-emergent adverse events were defined as adverse events that occurred after the subject received her initial dose of investigational product.	0.91% 1/110 • Number of events 1 • Day 1 through Week 48 of the study The safety population was defined as all randomized subjects who received at least 1 dose of investigational product (3 subjects in the oteseconazole group did not receive investigational product). Treatment-emergent adverse events were defined as adverse events that occurred after the subject received her initial dose of investigational product.
Nervous system disorders Motor dysfunction	0.46% 1/217 • Number of events 1 • Day 1 through Week 48 of the study The safety population was defined as all randomized subjects who received at least 1 dose of investigational product (3 subjects in the oteseconazole group did not receive investigational product). Treatment-emergent adverse events were defined as adverse events that occurred after the subject received her initial dose of investigational product.	0.00% 0/110 • Day 1 through Week 48 of the study The safety population was defined as all randomized subjects who received at least 1 dose of investigational product (3 subjects in the oteseconazole group did not receive investigational product). Treatment-emergent adverse events were defined as adverse events that occurred after the subject received her initial dose of investigational product.
Psychiatric disorders Depression	0.00% 0/217 • Day 1 through Week 48 of the study The safety population was defined as all randomized subjects who received at least 1 dose of investigational product (3 subjects in the oteseconazole group did not receive investigational product). Treatment-emergent adverse events were defined as adverse events that occurred after the subject received her initial dose of investigational product.	0.91% 1/110 • Number of events 4 • Day 1 through Week 48 of the study The safety population was defined as all randomized subjects who received at least 1 dose of investigational product (3 subjects in the oteseconazole group did not receive investigational product). Treatment-emergent adverse events were defined as adverse events that occurred after the subject received her initial dose of investigational product.
Reproductive system and breast disorders Uterine polyp	0.46% 1/217 • Number of events 1 • Day 1 through Week 48 of the study The safety population was defined as all randomized subjects who received at least 1 dose of investigational product (3 subjects in the oteseconazole group did not receive investigational product). Treatment-emergent adverse events were defined as adverse events that occurred after the subject received her initial dose of investigational product.	0.00% 0/110 • Day 1 through Week 48 of the study The safety population was defined as all randomized subjects who received at least 1 dose of investigational product (3 subjects in the oteseconazole group did not receive investigational product). Treatment-emergent adverse events were defined as adverse events that occurred after the subject received her initial dose of investigational product.
Vascular disorders Deep vein thrombosis	0.46% 1/217 • Number of events 1 • Day 1 through Week 48 of the study The safety population was defined as all randomized subjects who received at least 1 dose of investigational product (3 subjects in the oteseconazole group did not receive investigational product). Treatment-emergent adverse events were defined as adverse events that occurred after the subject received her initial dose of investigational product.	0.00% 0/110 • Day 1 through Week 48 of the study The safety population was defined as all randomized subjects who received at least 1 dose of investigational product (3 subjects in the oteseconazole group did not receive investigational product). Treatment-emergent adverse events were defined as adverse events that occurred after the subject received her initial dose of investigational product.

Other adverse events

Additional Information

Clinical Trial Administration

Mycovia Pharmaceuticals Inc

Phone: 919-467-8539

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER