Recurrent Vulvovaginal Candidiasis
Conditions
Keywords
Recurrent yeast infection, Recurrent yeast vaginitis, Chronic yeast vaginitis, Ibrexafungerp, SCY-078, RVVC
Brief summary
This study is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of oral ibrexafungerp (formerly SCY-078) compared to placebo in female subjects 12 years and older with recurrent VVC (RVVC).
Detailed description
This study is a Phase 3, multicenter, randomized, double-blind study to evaluate the efficacy and safety of oral ibrexafungerp (formerly SCY-078) compared to placebo in female subjects 12 years and older with RVVC. The primary objective of the study is to evaluate the efficacy of oral ibrexafungerp in preventing recurrences of VVC in subjects with RVVC based on Clinical Success. Approximately 320 subjects are planned to be enrolled into the study. All subjects will receive treatment with oral fluconazole for their acute episode present at screening. Subjects who respond to fluconazole for their acute episode will be enrolled in the prevention of recurrence phase of the study and randomized to ibrexafungerp or placebo. Subjects who fail treatment with fluconazole for their acute episode will be included in a nested open label Sub-Study, in which they will be offered one-day oral ibrexafungerp for their unresolved acute episode.
Interventions
150 mg every 72 hours for 3 doses
DRUGIBREXAFUNGERP
300 mg BID (one day) every 4 weeks for a total of 6 dosing days
DRUGPlacebo oral tablet
BID (one day) every 4 weeks for a total of 6 dosing days
Sponsors
Scynexis, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
Open label (acute phase treatment) followed by Randomized, Double Blinded phase
Eligibility
Sex/Gender
FEMALE
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Diagnosis of symptomatic VVC with microscopic examination with KOH positive for yeast and normal vaginal pH. * History of 3 or more episodes of VVC in the past 12 months. * Culture confirmation and resolution of the signs and symptoms of the initial VVC episode (with treatment). * Able to take oral tablets and capsules. Key
Exclusion criteria
* Vaginal conditions other than recurrent VVC that may interfere with the diagnosis or evaluation of response to therapy. * Recent use of systemic and/or topical vaginal antifungal products. * Pregnant. * History of major system organ disease.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Success | Week 24 | Efficacy as measured by the percentage of subjects with documented Clinical Success. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Percentage of Subjects With no Mycologically Proven Recurrence | Week 24 | Efficacy as measured by the percentage of subjects with no Mycologically Proven Recurrence |
| Safety and Tolerability | Week 24 | Safety as measured by the number of subjects who discontinue due to treatment related adverse events. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited based on physician referral at 49 medical centers between 21Oct2019 and 29Nov2021
Pre-assignment details
440 subjects were enrolled into the acute phase of the study with 156 of them discontinuing. 260 then entered into the recurrence phase
Participants by arm
| Arm | Count |
|---|---|
| Ibrexafungerp Oral Fluconazole 150 mg every 72 hours for 3 doses followed by Oral Ibrexafungerp 300 mg BID (one day) every 4 weeks for a total of 6 dosing days
Fluconazole Tablet: 150 mg every 72 hours for 3 doses
IBREXAFUNGERP: 300 mg BID (one day) every 4 weeks for a total of 6 dosing days | 130 |
| Placebo Oral Fluconazole 150 mg every 72 hours for 3 doses followed by Oral Placebo BID (one day) every 4 weeks for a total of 6 dosing days
Fluconazole Tablet: 150 mg every 72 hours for 3 doses
Placebo oral tablet: BID (one day) every 4 weeks for a total of 6 dosing days | 130 |
| Total | 260 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 2 |
| Overall Study | Lost to Follow-up | 3 | 5 |
| Overall Study | Other | 2 | 1 |
| Overall Study | Physician Decision | 2 | 0 |
| Overall Study | Pregnancy | 1 | 2 |
| Overall Study | Withdrawal by Subject | 4 | 6 |
Baseline characteristics
| Characteristic | Ibrexafungerp | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 0 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 129 Participants | 130 Participants | 259 Participants |
| Age, Continuous | 34.1 years STANDARD_DEVIATION 10.23 | 33.7 years STANDARD_DEVIATION 9.29 | 33.9 years STANDARD_DEVIATION 9.76 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 12 Participants | 10 Participants | 22 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 118 Participants | 120 Participants | 238 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants | 12 Participants | 21 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) White | 120 Participants | 114 Participants | 234 Participants |
| Region of Enrollment Bulgaria | 37 Participants | 35 Participants | 72 Participants |
| Region of Enrollment Poland | 17 Participants | 14 Participants | 31 Participants |
| Region of Enrollment Russia | 34 Participants | 38 Participants | 72 Participants |
| Region of Enrollment United States | 42 Participants | 43 Participants | 85 Participants |
| Sex: Female, Male Female | 130 Participants | 130 Participants | 260 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 130 | 0 / 130 |
| other Total, other adverse events | 66 / 130 | 41 / 130 |
| serious Total, serious adverse events | 1 / 130 | 0 / 130 |
Outcome results
Primary
Clinical Success
Efficacy as measured by the percentage of subjects with documented Clinical Success.
Time frame: Week 24
Population: Intent-to-Treat Set
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ibrexafungerp | Clinical Success | Clinical Success | 85 Participants |
| Ibrexafungerp | Clinical Success | Clinical Failure | 45 Participants |
| Placebo | Clinical Success | Clinical Success | 69 Participants |
| Placebo | Clinical Success | Clinical Failure | 61 Participants |
Secondary
Safety and Tolerability
Safety as measured by the number of subjects who discontinue due to treatment related adverse events.
Time frame: Week 24
Population: Safety Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ibrexafungerp | Safety and Tolerability | 0 Participants |
| Placebo | Safety and Tolerability | 1 Participants |
Secondary
The Percentage of Subjects With no Mycologically Proven Recurrence
Efficacy as measured by the percentage of subjects with no Mycologically Proven Recurrence
Time frame: Week 24
Population: Intent-to-Treat Set
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ibrexafungerp | The Percentage of Subjects With no Mycologically Proven Recurrence | No Mycologically Proven Recurrence | 92 Participants |
| Ibrexafungerp | The Percentage of Subjects With no Mycologically Proven Recurrence | Mycologically Proven Recurrence | 38 Participants |
| Placebo | The Percentage of Subjects With no Mycologically Proven Recurrence | No Mycologically Proven Recurrence | 76 Participants |
| Placebo | The Percentage of Subjects With no Mycologically Proven Recurrence | Mycologically Proven Recurrence | 54 Participants |