Trial Outcomes & Findings for Dose-Finding Study of Oral Ibrexafungep (SCY-078) vs. Oral Fluconazole in Subjects With Acute Vulvovaginal Candidiasis (NCT NCT03253094)
NCT ID: NCT03253094
Last Updated: 2021-08-12
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
PHASE2
Target enrollment
186 participants
Primary outcome timeframe
8-12 days
Results posted on
2021-08-12
Participant Flow
Participant milestones
| Measure |
Ibrexafungerp 750-mg
750 mg QD for 1 day only
|
Ibrexafungerp 300-mg
300 mg BID for 1 day only
|
Ibrexafungerp 450-mg
450 mg BID for 1 day only
|
Ibrexafungerp 150-mg
150 mg BID for 3 days
|
Ibrexafungerp 300-mg (3 Days)
300 mg BID for 3 days
|
Fluconazole
150 mg QD for 1 day
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
32
|
30
|
28
|
32
|
32
|
32
|
|
Overall Study
Subjects Discontinued
|
4
|
3
|
6
|
4
|
5
|
4
|
|
Overall Study
COMPLETED
|
28
|
27
|
22
|
28
|
27
|
28
|
|
Overall Study
NOT COMPLETED
|
4
|
3
|
6
|
4
|
5
|
4
|
Reasons for withdrawal
| Measure |
Ibrexafungerp 750-mg
750 mg QD for 1 day only
|
Ibrexafungerp 300-mg
300 mg BID for 1 day only
|
Ibrexafungerp 450-mg
450 mg BID for 1 day only
|
Ibrexafungerp 150-mg
150 mg BID for 3 days
|
Ibrexafungerp 300-mg (3 Days)
300 mg BID for 3 days
|
Fluconazole
150 mg QD for 1 day
|
|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Lack of Efficacy
|
0
|
0
|
2
|
1
|
2
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
1
|
0
|
1
|
|
Overall Study
Physician Decision
|
1
|
0
|
0
|
1
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
1
|
0
|
3
|
0
|
|
Overall Study
Other
|
0
|
1
|
2
|
1
|
0
|
0
|
Baseline Characteristics
Dose-Finding Study of Oral Ibrexafungep (SCY-078) vs. Oral Fluconazole in Subjects With Acute Vulvovaginal Candidiasis
Baseline characteristics by cohort
| Measure |
Ibrexafungerp 750-mg
n=32 Participants
750 mg QD for 1 day only
|
Ibrexafungerp 300-mg
n=30 Participants
300 mg BID for 1 day only
|
Ibrexafungerp 450-mg
n=28 Participants
450 mg BID for 1 day only
|
Ibrexafungerp 150-mg
n=32 Participants
150 mg BID for 3 days
|
Ibrexafungerp 300-mg (3 Days)
n=32 Participants
300 mg BID for 3 days
|
Fluconazole
n=32 Participants
150 mg QD for 1 day
|
Total
n=186 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
34.6 years
STANDARD_DEVIATION 12.3 • n=5 Participants
|
34.4 years
STANDARD_DEVIATION 11.3 • n=7 Participants
|
34.5 years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
33.3 years
STANDARD_DEVIATION 10.5 • n=4 Participants
|
32.0 years
STANDARD_DEVIATION 8.5 • n=21 Participants
|
33.8 years
STANDARD_DEVIATION 10.1 • n=10 Participants
|
33.7 years
STANDARD_DEVIATION 10.4 • n=115 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
32 Participants
n=21 Participants
|
32 Participants
n=10 Participants
|
186 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
11 Participants
n=10 Participants
|
56 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
21 Participants
n=10 Participants
|
130 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
3 Participants
n=115 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
13 Participants
n=10 Participants
|
72 Participants
n=115 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
19 Participants
n=10 Participants
|
109 Participants
n=115 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
|
Region of Enrollment
United States
|
32 participants
n=5 Participants
|
30 participants
n=7 Participants
|
28 participants
n=5 Participants
|
32 participants
n=4 Participants
|
32 participants
n=21 Participants
|
32 participants
n=10 Participants
|
186 participants
n=115 Participants
|
PRIMARY outcome
Timeframe: 8-12 daysPopulation: 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 750-mg
n=26 Participants
750 mg QD D1 only
|
Ibrexafungerp 300-mg
n=27 Participants
300 mg BID D1 only
|
Ibrexafungerp 450-mg
n=21 Participants
450 mg BID D1 only
|
Ibrexafungerp 150-mg
n=29 Participants
150 mg BID D1 to D3
|
Ibrexafungerp 300-mg D1 to D3
n=26 Participants
300 mg BID D1 to D3
|
Fluconazole
n=24 Participants
150 mg QD D1 only
|
|---|---|---|---|---|---|---|
|
Clinical Cure (Complete Resolution of Signs and Symptoms)
Clinical cure
|
9 Participants
|
14 Participants
|
13 Participants
|
14 Participants
|
15 Participants
|
14 Participants
|
|
Clinical Cure (Complete Resolution of Signs and Symptoms)
Clinical failure
|
17 Participants
|
13 Participants
|
8 Participants
|
15 Participants
|
11 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: 29 daysPopulation: mITT
The percentage of subjects with both clinical cure and mycological eradication (negative fungal culture) the Test-of cure.
Outcome measures
| Measure |
Ibrexafungerp 750-mg
n=26 Participants
750 mg QD D1 only
|
Ibrexafungerp 300-mg
n=27 Participants
300 mg BID D1 only
|
Ibrexafungerp 450-mg
n=21 Participants
450 mg BID D1 only
|
Ibrexafungerp 150-mg
n=29 Participants
150 mg BID D1 to D3
|
Ibrexafungerp 300-mg D1 to D3
n=26 Participants
300 mg BID D1 to D3
|
Fluconazole
n=24 Participants
150 mg QD D1 only
|
|---|---|---|---|---|---|---|
|
Co-occurrence of Clinical and Mycological Cure
Clinical cure and Mycological Eradication
|
4 Participants
|
10 Participants
|
11 Participants
|
8 Participants
|
13 Participants
|
10 Participants
|
|
Co-occurrence of Clinical and Mycological Cure
Clinical failure and/or mycological persistence
|
22 Participants
|
17 Participants
|
10 Participants
|
21 Participants
|
13 Participants
|
14 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: up to 29 daysThe number of subjects with treatment related adverse events
Outcome measures
| Measure |
Ibrexafungerp 750-mg
n=32 Participants
750 mg QD D1 only
|
Ibrexafungerp 300-mg
n=30 Participants
300 mg BID D1 only
|
Ibrexafungerp 450-mg
n=28 Participants
450 mg BID D1 only
|
Ibrexafungerp 150-mg
n=31 Participants
150 mg BID D1 to D3
|
Ibrexafungerp 300-mg D1 to D3
n=32 Participants
300 mg BID D1 to D3
|
Fluconazole
n=32 Participants
150 mg QD D1 only
|
|---|---|---|---|---|---|---|
|
Incidence of Treatment Emergent Adverse Events
Treatment related Treatment-emergent adverse event
|
20 Participants
|
14 Participants
|
16 Participants
|
12 Participants
|
15 Participants
|
8 Participants
|
|
Incidence of Treatment Emergent Adverse Events
No Treatment related Treatment-emergent adverse event
|
12 Participants
|
16 Participants
|
12 Participants
|
19 Participants
|
17 Participants
|
24 Participants
|
Adverse Events
Ibrexafungerp 750-mg
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Ibrexafungerp 300-mg
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Ibrexafungerp 450-mg
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Ibrexafungerp 150-mg
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Ibrexafungerp 300-mg D1 to D3
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Fluconazole
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Ibrexafungerp 750-mg
n=32 participants at risk
750 mg QD D1 only
|
Ibrexafungerp 300-mg
n=30 participants at risk
300 mg BID D1 only
|
Ibrexafungerp 450-mg
n=28 participants at risk
450 mg BID D1 only
|
Ibrexafungerp 150-mg
n=31 participants at risk
150 mg BID D1 to D3
|
Ibrexafungerp 300-mg D1 to D3
n=32 participants at risk
300 mg BID D1 to D3
|
Fluconazole
n=32 participants at risk
150 mg QD D1 only
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
15.6%
5/32 • 29 days
|
3.3%
1/30 • 29 days
|
7.1%
2/28 • 29 days
|
9.7%
3/31 • 29 days
|
0.00%
0/32 • 29 days
|
9.4%
3/32 • 29 days
|
|
Gastrointestinal disorders
Abdominal pain upper
|
3.1%
1/32 • 29 days
|
0.00%
0/30 • 29 days
|
7.1%
2/28 • 29 days
|
6.5%
2/31 • 29 days
|
9.4%
3/32 • 29 days
|
3.1%
1/32 • 29 days
|
|
Gastrointestinal disorders
Diarrhoea
|
46.9%
15/32 • 29 days
|
16.7%
5/30 • 29 days
|
21.4%
6/28 • 29 days
|
12.9%
4/31 • 29 days
|
40.6%
13/32 • 29 days
|
3.1%
1/32 • 29 days
|
|
Gastrointestinal disorders
Nausea
|
25.0%
8/32 • 29 days
|
10.0%
3/30 • 29 days
|
28.6%
8/28 • 29 days
|
19.4%
6/31 • 29 days
|
18.8%
6/32 • 29 days
|
6.2%
2/32 • 29 days
|
|
Gastrointestinal disorders
Vomiting
|
3.1%
1/32 • 29 days
|
0.00%
0/30 • 29 days
|
14.3%
4/28 • 29 days
|
0.00%
0/31 • 29 days
|
6.2%
2/32 • 29 days
|
0.00%
0/32 • 29 days
|
|
Investigations
Blood creatine phosphokinase increased
|
6.2%
2/32 • 29 days
|
3.3%
1/30 • 29 days
|
0.00%
0/28 • 29 days
|
6.5%
2/31 • 29 days
|
0.00%
0/32 • 29 days
|
3.1%
1/32 • 29 days
|
|
Nervous system disorders
Dizziness
|
3.1%
1/32 • 29 days
|
6.7%
2/30 • 29 days
|
7.1%
2/28 • 29 days
|
9.7%
3/31 • 29 days
|
0.00%
0/32 • 29 days
|
0.00%
0/32 • 29 days
|
|
Nervous system disorders
Headache
|
9.4%
3/32 • 29 days
|
10.0%
3/30 • 29 days
|
10.7%
3/28 • 29 days
|
29.0%
9/31 • 29 days
|
12.5%
4/32 • 29 days
|
6.2%
2/32 • 29 days
|
|
Nervous system disorders
Somnolence
|
3.1%
1/32 • 29 days
|
0.00%
0/30 • 29 days
|
0.00%
0/28 • 29 days
|
0.00%
0/31 • 29 days
|
0.00%
0/32 • 29 days
|
6.2%
2/32 • 29 days
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/32 • 29 days
|
6.7%
2/30 • 29 days
|
0.00%
0/28 • 29 days
|
0.00%
0/31 • 29 days
|
0.00%
0/32 • 29 days
|
3.1%
1/32 • 29 days
|
|
General disorders
Fatigue
|
0.00%
0/32 • 29 days
|
3.3%
1/30 • 29 days
|
0.00%
0/28 • 29 days
|
6.5%
2/31 • 29 days
|
6.2%
2/32 • 29 days
|
6.2%
2/32 • 29 days
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/32 • 29 days
|
6.7%
2/30 • 29 days
|
0.00%
0/28 • 29 days
|
0.00%
0/31 • 29 days
|
3.1%
1/32 • 29 days
|
0.00%
0/32 • 29 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place