Candida Vulvovaginitis
Conditions
Keywords
Vaginitis, Yeast infection
Brief summary
This is a Phase 3, randomized, multicenter, double-blind, placebo-controlled study to evaluate the efficacy and safety of oral Ibrexafungerp (SCY-078) compared to placebo in female subjects 12 years and older with AVVC.
Detailed description
Subjects who meet all of the inclusion and none of the exclusion criteria will be enrolled into the study and will be randomized in a 2:1 ratio to either oral ibrexafungerp or ibrexafungerp matching placebo, as follows: * Oral ibrexafungerp 300-mg dose BID (bis in die) for 1 day * Oral ibrexafungerp matching placebo BID for 1 day This is a randomized, double-blind study. Approximately 366 eligible subjects will be enrolled and randomized in a 2:1 ratio to one of the two study treatment groups. Subjects will be followed for assessments of efficacy and safety for approximately one month after study drug administration. The design of this study is identical to VANISH 303 Study: NCT03734991
Interventions
DRUGIbrexafungerp
Ibrexafungerp 300mg BID for one day
DRUGPlacebo
Matching Placebo
Sponsors
Scynexis, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Randomized, placebo-controlled, double-blind study
Eligibility
Sex/Gender
FEMALE
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject is a postmenarchal female subject 12 years and older * Subject has a diagnosis of symptomatic AVVC at baseline including a positive microscopic examination with 10% Potassium Hydroxide (KOH) in a vaginal sample revealing yeast forms (hyphae/pseudohyphae) or budding yeasts, and vaginal pH (≤4.5)
Exclusion criteria
* Subject has any vaginal condition other than AVVC that may interfere with the diagnosis or evaluation of response to therapy, such as suspected or confirmed concurrent causes of vulvovaginitis and/or cervicitis (mixed infection) * Need for systemic and/or topical (vaginal) anti fungal treatment, including prescription or over-the-counter products during the study and treatment for vulvovaginal candidiasis (VVC) 28 days prior to randomization. * Subject has uncontrolled diabetes mellitus. * Subject has a vaginal sample with pH \>4.5. * Subject has a history of or an active cervical/vaginal cancer.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Cure (Complete Resolution of Signs and Symptoms) | Day 8-14 | The percentage of subjects with clinical cure (complete resolution of signs and symptoms) at the test-of-cure (TOC) visit |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mycological Eradication (Negative Culture for Growth of Yeast) | Day 8-14 | The percentage of subjects with mycological eradication (negative culture for growth of Candida species) at the TOC visit |
| Clinical Cure and Mycological Eradication (Responder Outcome) | Day 8-14 | The percentage of subjects with clinical cure and mycological eradication (responder outcome) at the TOC visit |
| Complete Clinical Response at Follow-up | Day 25 | The percentage of subjects with complete resolution of signs and symptoms at the Follow-up (FU) visit |
| Safety and Tolerability of Ibrexafungerp | Up to 29 Days | Number of subjects with treatment related adverse events |
Countries
Bulgaria, United States
Participant flow
Recruitment details
Participants were recruited based on physician referral at 22 medical center between 07Jun2019 and 07Feb2020.
Participants by arm
| Arm | Count |
|---|---|
| Ibrexafungerp (SCY-078) 300 mg BID for one day
Ibrexafungerp: Ibrexafungerp 300mg BID for one day | 298 |
| Placebo Matching Placebo
Placebo: Matching Placebo | 151 |
| Total | 449 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 3 | 0 |
| Overall Study | Lack of Efficacy or Use of antifungal therapy | 43 | 41 |
| Overall Study | Lost to Follow-up | 1 | 2 |
| Overall Study | Other | 2 | 5 |
| Overall Study | Physician Decision | 0 | 1 |
| Overall Study | Pregnancy | 1 | 0 |
| Overall Study | Withdrawal by Subject | 7 | 1 |
Baseline characteristics
| Characteristic | Placebo | Total | Ibrexafungerp (SCY-078) |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 4 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 149 Participants | 445 Participants | 296 Participants |
| Age, Continuous | 34.5 years STANDARD_DEVIATION 10.94 | 34.2 years STANDARD_DEVIATION 10.61 | 34.1 years STANDARD_DEVIATION 10.45 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 14 Participants | 50 Participants | 36 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 137 Participants | 399 Participants | 262 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 27 Participants | 78 Participants | 51 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 | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 123 Participants | 369 Participants | 246 Participants |
| Region of Enrollment Bulgaria | 85 participants | 278 participants | 193 participants |
| Region of Enrollment United States | 66 participants | 171 participants | 105 participants |
| Sex: Female, Male Female | 151 Participants | 449 Participants | 298 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 / 298 | 0 / 151 |
| other Total, other adverse events | 63 / 298 | 15 / 151 |
| serious Total, serious adverse events | 1 / 298 | 1 / 151 |
Outcome results
Primary
Clinical Cure (Complete Resolution of Signs and Symptoms)
The percentage of subjects with clinical cure (complete resolution of signs and symptoms) at the test-of-cure (TOC) visit
Time frame: Day 8-14
Population: mITT
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ibrexafungerp (SCY-078) | Clinical Cure (Complete Resolution of Signs and Symptoms) | Clinical cure | 119 Participants |
| Ibrexafungerp (SCY-078) | Clinical Cure (Complete Resolution of Signs and Symptoms) | Clinical failure | 69 Participants |
| Placebo | Clinical Cure (Complete Resolution of Signs and Symptoms) | Clinical cure | 37 Participants |
| Placebo | Clinical Cure (Complete Resolution of Signs and Symptoms) | Clinical failure | 47 Participants |
Secondary
Clinical Cure and Mycological Eradication (Responder Outcome)
The percentage of subjects with clinical cure and mycological eradication (responder outcome) at the TOC visit
Time frame: Day 8-14
Population: mITT
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ibrexafungerp (SCY-078) | Clinical Cure and Mycological Eradication (Responder Outcome) | Overall success | 82 Participants |
| Ibrexafungerp (SCY-078) | Clinical Cure and Mycological Eradication (Responder Outcome) | Overall failure | 96 Participants |
| Placebo | Clinical Cure and Mycological Eradication (Responder Outcome) | Overall success | 23 Participants |
| Placebo | Clinical Cure and Mycological Eradication (Responder Outcome) | Overall failure | 58 Participants |
Secondary
Complete Clinical Response at Follow-up
The percentage of subjects with complete resolution of signs and symptoms at the Follow-up (FU) visit
Time frame: Day 25
Population: mITT
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ibrexafungerp (SCY-078) | Complete Clinical Response at Follow-up | Clinical cure at Follow up | 137 Participants |
| Ibrexafungerp (SCY-078) | Complete Clinical Response at Follow-up | Clinical failure at Follow up | 52 Participants |
| Placebo | Complete Clinical Response at Follow-up | Clinical cure at Follow up | 44 Participants |
| Placebo | Complete Clinical Response at Follow-up | Clinical failure at Follow up | 45 Participants |
Secondary
Mycological Eradication (Negative Culture for Growth of Yeast)
The percentage of subjects with mycological eradication (negative culture for growth of Candida species) at the TOC visit
Time frame: Day 8-14
Population: mITT
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ibrexafungerp (SCY-078) | Mycological Eradication (Negative Culture for Growth of Yeast) | Mycological eradication | 110 Participants |
| Ibrexafungerp (SCY-078) | Mycological Eradication (Negative Culture for Growth of Yeast) | Mycological persistence | 78 Participants |
| Placebo | Mycological Eradication (Negative Culture for Growth of Yeast) | Mycological eradication | 25 Participants |
| Placebo | Mycological Eradication (Negative Culture for Growth of Yeast) | Mycological persistence | 59 Participants |
Secondary
Safety and Tolerability of Ibrexafungerp
Number of subjects with treatment related adverse events
Time frame: Up to 29 Days
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ibrexafungerp (SCY-078) | Safety and Tolerability of Ibrexafungerp | Any serious treatment-emergent adverse event | 1 Participants |
| Ibrexafungerp (SCY-078) | Safety and Tolerability of Ibrexafungerp | Any treatment-emergent adverse event leading to treatment discontinuation | 0 Participants |
| Ibrexafungerp (SCY-078) | Safety and Tolerability of Ibrexafungerp | Any treatment-related treatment-emergent serious adverse event | 0 Participants |
| Ibrexafungerp (SCY-078) | Safety and Tolerability of Ibrexafungerp | Any adverse event leading to death | 0 Participants |
| Ibrexafungerp (SCY-078) | Safety and Tolerability of Ibrexafungerp | Any treatment-emergent adverse event | 99 Participants |
| Placebo | Safety and Tolerability of Ibrexafungerp | Any adverse event leading to death | 0 Participants |
| Placebo | Safety and Tolerability of Ibrexafungerp | Any treatment-emergent adverse event | 44 Participants |
| Placebo | Safety and Tolerability of Ibrexafungerp | Any serious treatment-emergent adverse event | 1 Participants |
| Placebo | Safety and Tolerability of Ibrexafungerp | Any treatment-related treatment-emergent serious adverse event | 0 Participants |
| Placebo | Safety and Tolerability of Ibrexafungerp | Any treatment-emergent adverse event leading to treatment discontinuation | 0 Participants |