Trial Outcomes & Findings for Efficacy and Safety of Oral Ibrexafungerp (SCY-078) vs. Placebo in Subjects With Acute Vulvovaginal Candidiasis (VANISH 303) (NCT NCT03734991)
NCT ID: NCT03734991
Last Updated: 2021-09-08
Results Overview
measured by the percentage of subjects with clinical cure (complete resolution of signs and symptoms) at the test-of-cure (TOC) visit
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
376 participants
Primary outcome timeframe
Day 8-14
Results posted on
2021-09-08
Participant Flow
Participants were recruited based on physician referral at 28 medical centers between 04Jan2019 and 04Sep2019.
Participant milestones
| Measure |
Ibrexafungerp (SCY-078)
300 mg orally every 12 hrs for 1 day (2 doses in 1 day)
Ibrexafungerp: Ibrexafungerp 300 mg BID for 1 day
|
Placebo
Matching Placebo
Placebo: Matching placebo
|
|---|---|---|
|
Overall Study
STARTED
|
249
|
127
|
|
Overall Study
Withdrawn Before Treatment
|
2
|
3
|
|
Overall Study
Withdrawn Before TOC
|
59
|
41
|
|
Overall Study
Completed the TOC Visit
|
188
|
83
|
|
Overall Study
Withdrawn At or After the TOC Visit
|
5
|
3
|
|
Overall Study
COMPLETED
|
183
|
80
|
|
Overall Study
NOT COMPLETED
|
66
|
47
|
Reasons for withdrawal
| Measure |
Ibrexafungerp (SCY-078)
300 mg orally every 12 hrs for 1 day (2 doses in 1 day)
Ibrexafungerp: Ibrexafungerp 300 mg BID for 1 day
|
Placebo
Matching Placebo
Placebo: Matching placebo
|
|---|---|---|
|
Overall Study
Adverse Event
|
4
|
0
|
|
Overall Study
Lost to Follow-up
|
4
|
0
|
|
Overall Study
Physician Decision
|
0
|
1
|
|
Overall Study
Pregnancy
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
6
|
3
|
|
Overall Study
Lack of efficacy and or/use of antifungal therapy
|
49
|
41
|
|
Overall Study
Other
|
2
|
2
|
Baseline Characteristics
Efficacy and Safety of Oral Ibrexafungerp (SCY-078) vs. Placebo in Subjects With Acute Vulvovaginal Candidiasis (VANISH 303)
Baseline characteristics by cohort
| Measure |
Ibrexafungerp (SCY-078)
n=247 Participants
300 mg orally every 12 hrs for 1 day (2 doses in 1 day)
Ibrexafungerp: Ibrexafungerp 300 mg BID for 1 day
|
Placebo
n=124 Participants
Matching Placebo
Placebo: Matching placebo
|
Total
n=371 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
244 Participants
n=5 Participants
|
120 Participants
n=7 Participants
|
364 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Age, Continuous
|
34.5 years
STANDARD_DEVIATION 11.22 • n=5 Participants
|
35.8 years
STANDARD_DEVIATION 12.47 • n=7 Participants
|
34.9 years
STANDARD_DEVIATION 11.63 • n=5 Participants
|
|
Sex: Female, Male
Female
|
247 Participants
n=5 Participants
|
124 Participants
n=7 Participants
|
371 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
64 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
183 Participants
n=5 Participants
|
99 Participants
n=7 Participants
|
282 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 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
|
101 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
152 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
132 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
203 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
|
8 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
247 participants
n=5 Participants
|
124 participants
n=7 Participants
|
371 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 8-14Population: mITT
measured by the percentage of subjects with clinical cure (complete resolution of signs and symptoms) at the test-of-cure (TOC) visit
Outcome measures
| Measure |
Ibrexafungerp (SCY-078)
n=188 Participants
300 mg orally every 12 hrs for 1 day (2 doses in 1 day)
Ibrexafungerp: Ibrexafungerp 300 mg BID for 1 day
|
Placebo
n=98 Participants
Matching Placebo
Placebo: Matching placebo
|
|---|---|---|
|
Clinical Cure (Complete Resolution of Signs and Symptoms)
Clinical cure
|
95 Participants
|
28 Participants
|
|
Clinical Cure (Complete Resolution of Signs and Symptoms)
Clinical failure
|
93 Participants
|
70 Participants
|
SECONDARY outcome
Timeframe: Day 8-14Population: mITT
percentage of subjects with mycological eradication (negative culture for growth of Candida species) at the TOC visit
Outcome measures
| Measure |
Ibrexafungerp (SCY-078)
n=188 Participants
300 mg orally every 12 hrs for 1 day (2 doses in 1 day)
Ibrexafungerp: Ibrexafungerp 300 mg BID for 1 day
|
Placebo
n=98 Participants
Matching Placebo
Placebo: Matching placebo
|
|---|---|---|
|
Mycological Eradication (Negative Culture for Growth of Yeast)
Mycological eradication
|
93 Participants
|
19 Participants
|
|
Mycological Eradication (Negative Culture for Growth of Yeast)
Mycological persistence
|
95 Participants
|
79 Participants
|
SECONDARY outcome
Timeframe: Day 8-14Population: mITT
percentage of subjects with clinical cure and mycological eradication (responder outcome) at the TOC visit
Outcome measures
| Measure |
Ibrexafungerp (SCY-078)
n=178 Participants
300 mg orally every 12 hrs for 1 day (2 doses in 1 day)
Ibrexafungerp: Ibrexafungerp 300 mg BID for 1 day
|
Placebo
n=95 Participants
Matching Placebo
Placebo: Matching placebo
|
|---|---|---|
|
Clinical Cure and Mycological Eradication (Responder Outcome)
Overall success
|
64 Participants
|
12 Participants
|
|
Clinical Cure and Mycological Eradication (Responder Outcome)
Overall failure
|
114 Participants
|
83 Participants
|
SECONDARY outcome
Timeframe: Day 25Population: mITT
percentage of subjects with complete resolution of signs and symptoms at the Follow-up (FU) visit
Outcome measures
| Measure |
Ibrexafungerp (SCY-078)
n=190 Participants
300 mg orally every 12 hrs for 1 day (2 doses in 1 day)
Ibrexafungerp: Ibrexafungerp 300 mg BID for 1 day
|
Placebo
n=100 Participants
Matching Placebo
Placebo: Matching placebo
|
|---|---|---|
|
Complete Clinical Response at Follow-Up
Clinical cure at Follow up
|
113 Participants
|
44 Participants
|
|
Complete Clinical Response at Follow-Up
Clinical failure at Follow up
|
77 Participants
|
56 Participants
|
SECONDARY outcome
Timeframe: Up to 29 daysNumber of subjects with treatment related adverse events
Outcome measures
| Measure |
Ibrexafungerp (SCY-078)
n=247 Participants
300 mg orally every 12 hrs for 1 day (2 doses in 1 day)
Ibrexafungerp: Ibrexafungerp 300 mg BID for 1 day
|
Placebo
n=124 Participants
Matching Placebo
Placebo: Matching placebo
|
|---|---|---|
|
Overall Treatment-Emergent Adverse Events (Safety Set)
Any treatment-emergent, treatment-related adverse event
|
98 Participants
|
21 Participants
|
|
Overall Treatment-Emergent Adverse Events (Safety Set)
No treatment-emergent, treatment-related adverse events
|
149 Participants
|
103 Participants
|
Adverse Events
Ibrexafungerp (SCY-078)
Serious events: 1 serious events
Other events: 117 other events
Deaths: 0 deaths
Placebo
Serious events: 2 serious events
Other events: 34 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ibrexafungerp (SCY-078)
n=247 participants at risk
300 mg orally every 12 hrs for 1 day (2 doses in 1 day)
Ibrexafungerp: Ibrexafungerp 300 mg BID for 1 day
|
Placebo
n=124 participants at risk
Matching Placebo
Placebo: Matching placebo
|
|---|---|---|
|
Investigations
Hypokalaemia
|
0.00%
0/247 • 4 weeks after last dose
|
0.81%
1/124 • 4 weeks after last dose
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/247 • 4 weeks after last dose
|
0.81%
1/124 • 4 weeks after last dose
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia and bronchial hyperreactivity
|
0.40%
1/247 • 4 weeks after last dose
|
0.00%
0/124 • 4 weeks after last dose
|
Other adverse events
| Measure |
Ibrexafungerp (SCY-078)
n=247 participants at risk
300 mg orally every 12 hrs for 1 day (2 doses in 1 day)
Ibrexafungerp: Ibrexafungerp 300 mg BID for 1 day
|
Placebo
n=124 participants at risk
Matching Placebo
Placebo: Matching placebo
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
25.5%
63/247 • 4 weeks after last dose
|
6.5%
8/124 • 4 weeks after last dose
|
|
Gastrointestinal disorders
Nausea
|
16.2%
40/247 • 4 weeks after last dose
|
5.6%
7/124 • 4 weeks after last dose
|
|
Gastrointestinal disorders
Abdominal pain
|
6.9%
17/247 • 4 weeks after last dose
|
2.4%
3/124 • 4 weeks after last dose
|
|
Gastrointestinal disorders
Abdominal discomfort
|
5.7%
14/247 • 4 weeks after last dose
|
1.6%
2/124 • 4 weeks after last dose
|
|
Infections and infestations
Bacterial vaginosis
|
5.3%
13/247 • 4 weeks after last dose
|
8.1%
10/124 • 4 weeks after last dose
|
|
Nervous system disorders
Headache
|
9.3%
23/247 • 4 weeks after last dose
|
8.9%
11/124 • 4 weeks after last dose
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place