Trial Outcomes & Findings for Efficacy and Safety of Oral Ibrexafungerp (SCY-078) vs. Placebo in Subjects With Acute Vulvovaginal Candidiasis (NCT NCT03987620)
NCT ID: NCT03987620
Last Updated: 2021-09-08
Results Overview
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
455 participants
Primary outcome timeframe
Day 8-14
Results posted on
2021-09-08
Participant Flow
Participants were recruited based on physician referral at 22 medical center between 07Jun2019 and 07Feb2020.
Participant milestones
| Measure |
Ibrexafungerp (SCY-078)
300 mg BID for one day
Ibrexafungerp: Ibrexafungerp 300mg BID for one day
|
Placebo
Matching Placebo
Placebo: Matching Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
303
|
152
|
|
Overall Study
Withdrawn Before Treatment
|
5
|
1
|
|
Overall Study
Withdrawn Before TOC
|
48
|
45
|
|
Overall Study
Completed the TOC Visit
|
250
|
106
|
|
Overall Study
Withdrawn At or After the TOC Visit
|
4
|
4
|
|
Overall Study
COMPLETED
|
246
|
102
|
|
Overall Study
NOT COMPLETED
|
57
|
50
|
Reasons for withdrawal
| Measure |
Ibrexafungerp (SCY-078)
300 mg BID for one day
Ibrexafungerp: Ibrexafungerp 300mg BID for one day
|
Placebo
Matching Placebo
Placebo: Matching Placebo
|
|---|---|---|
|
Overall Study
Lack of Efficacy or Use of antifungal therapy
|
43
|
41
|
|
Overall Study
Adverse Event
|
3
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
|
Overall Study
Physician Decision
|
0
|
1
|
|
Overall Study
Pregnancy
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
7
|
1
|
|
Overall Study
Other
|
2
|
5
|
Baseline Characteristics
Efficacy and Safety of Oral Ibrexafungerp (SCY-078) vs. Placebo in Subjects With Acute Vulvovaginal Candidiasis
Baseline characteristics by cohort
| Measure |
Ibrexafungerp (SCY-078)
n=298 Participants
300 mg BID for one day
Ibrexafungerp: Ibrexafungerp 300mg BID for one day
|
Placebo
n=151 Participants
Matching Placebo
Placebo: Matching Placebo
|
Total
n=449 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
296 Participants
n=5 Participants
|
149 Participants
n=7 Participants
|
445 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Age, Continuous
|
34.1 years
STANDARD_DEVIATION 10.45 • n=5 Participants
|
34.5 years
STANDARD_DEVIATION 10.94 • n=7 Participants
|
34.2 years
STANDARD_DEVIATION 10.61 • n=5 Participants
|
|
Sex: Female, Male
Female
|
298 Participants
n=5 Participants
|
151 Participants
n=7 Participants
|
449 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
|
36 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
262 Participants
n=5 Participants
|
137 Participants
n=7 Participants
|
399 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
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
51 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
246 Participants
n=5 Participants
|
123 Participants
n=7 Participants
|
369 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
105 participants
n=5 Participants
|
66 participants
n=7 Participants
|
171 participants
n=5 Participants
|
|
Region of Enrollment
Bulgaria
|
193 participants
n=5 Participants
|
85 participants
n=7 Participants
|
278 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 8-14Population: mITT
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 BID for one day
Ibrexafungerp: Ibrexafungerp 300mg BID for one day
|
Placebo
n=84 Participants
Matching Placebo
Placebo: Matching Placebo
|
|---|---|---|
|
Clinical Cure (Complete Resolution of Signs and Symptoms)
Clinical cure
|
119 Participants
|
37 Participants
|
|
Clinical Cure (Complete Resolution of Signs and Symptoms)
Clinical failure
|
69 Participants
|
47 Participants
|
SECONDARY outcome
Timeframe: Day 8-14Population: mITT
The 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 BID for one day
Ibrexafungerp: Ibrexafungerp 300mg BID for one day
|
Placebo
n=84 Participants
Matching Placebo
Placebo: Matching Placebo
|
|---|---|---|
|
Mycological Eradication (Negative Culture for Growth of Yeast)
Mycological eradication
|
110 Participants
|
25 Participants
|
|
Mycological Eradication (Negative Culture for Growth of Yeast)
Mycological persistence
|
78 Participants
|
59 Participants
|
SECONDARY outcome
Timeframe: Day 8-14Population: mITT
The 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 BID for one day
Ibrexafungerp: Ibrexafungerp 300mg BID for one day
|
Placebo
n=81 Participants
Matching Placebo
Placebo: Matching Placebo
|
|---|---|---|
|
Clinical Cure and Mycological Eradication (Responder Outcome)
Overall success
|
82 Participants
|
23 Participants
|
|
Clinical Cure and Mycological Eradication (Responder Outcome)
Overall failure
|
96 Participants
|
58 Participants
|
SECONDARY outcome
Timeframe: Day 25Population: mITT
The percentage of subjects with complete resolution of signs and symptoms at the Follow-up (FU) visit
Outcome measures
| Measure |
Ibrexafungerp (SCY-078)
n=189 Participants
300 mg BID for one day
Ibrexafungerp: Ibrexafungerp 300mg BID for one day
|
Placebo
n=89 Participants
Matching Placebo
Placebo: Matching Placebo
|
|---|---|---|
|
Complete Clinical Response at Follow-up
Clinical failure at Follow up
|
52 Participants
|
45 Participants
|
|
Complete Clinical Response at Follow-up
Clinical cure at Follow up
|
137 Participants
|
44 Participants
|
SECONDARY outcome
Timeframe: Up to 29 DaysNumber of subjects with treatment related adverse events
Outcome measures
| Measure |
Ibrexafungerp (SCY-078)
n=100 Participants
300 mg BID for one day
Ibrexafungerp: Ibrexafungerp 300mg BID for one day
|
Placebo
n=45 Participants
Matching Placebo
Placebo: Matching Placebo
|
|---|---|---|
|
Safety and Tolerability of Ibrexafungerp
Any treatment-emergent adverse event
|
99 Participants
|
44 Participants
|
|
Safety and Tolerability of Ibrexafungerp
Any serious treatment-emergent adverse event
|
1 Participants
|
1 Participants
|
|
Safety and Tolerability of Ibrexafungerp
Any treatment-emergent adverse event leading to treatment discontinuation
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Ibrexafungerp
Any treatment-related treatment-emergent serious adverse event
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Ibrexafungerp
Any adverse event leading to death
|
0 Participants
|
0 Participants
|
Adverse Events
Ibrexafungerp (SCY-078)
Serious events: 1 serious events
Other events: 63 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ibrexafungerp (SCY-078)
n=298 participants at risk
300 mg BID for one day
Ibrexafungerp: Ibrexafungerp 300mg BID for one day
|
Placebo
n=151 participants at risk
Matching Placebo
Placebo: Matching Placebo
|
|---|---|---|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/298 • 4 weeks after last dose
|
0.66%
1/151 • 4 weeks after last dose
|
|
Gastrointestinal disorders
Gastrointestinal bacterial infection
|
0.34%
1/298 • 4 weeks after last dose
|
0.00%
0/151 • 4 weeks after last dose
|
Other adverse events
| Measure |
Ibrexafungerp (SCY-078)
n=298 participants at risk
300 mg BID for one day
Ibrexafungerp: Ibrexafungerp 300mg BID for one day
|
Placebo
n=151 participants at risk
Matching Placebo
Placebo: Matching Placebo
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
9.4%
28/298 • 4 weeks after last dose
|
0.66%
1/151 • 4 weeks after last dose
|
|
Gastrointestinal disorders
Nausea
|
8.4%
25/298 • 4 weeks after last dose
|
2.6%
4/151 • 4 weeks after last dose
|
|
Nervous system disorders
Headache
|
7.4%
22/298 • 4 weeks after last dose
|
7.3%
11/151 • 4 weeks after last dose
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place