Trial Outcomes & Findings for Phase 3 Study of Oral Ibrexafungerp (SCY-078) Vs. Placebo in Subjects With Recurrent Vulvovaginal Candidiasis (VVC) (NCT NCT04029116)
NCT ID: NCT04029116
Last Updated: 2023-06-18
Results Overview
Efficacy as measured by the percentage of subjects with documented Clinical Success.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
440 participants
Primary outcome timeframe
Week 24
Results posted on
2023-06-18
Participant Flow
Participants were recruited based on physician referral at 49 medical centers between 21Oct2019 and 29Nov2021
440 subjects were enrolled into the acute phase of the study with 156 of them discontinuing. 260 then entered into the recurrence phase
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
130
|
130
|
|
Overall Study
Discontinued
|
12
|
16
|
|
Overall Study
COMPLETED
|
118
|
114
|
|
Overall Study
NOT COMPLETED
|
12
|
16
|
Reasons for withdrawal
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
2
|
|
Overall Study
Lost to Follow-up
|
3
|
5
|
|
Overall Study
Physician Decision
|
2
|
0
|
|
Overall Study
Pregnancy
|
1
|
2
|
|
Overall Study
Withdrawal by Subject
|
4
|
6
|
|
Overall Study
Other
|
2
|
1
|
Baseline Characteristics
Phase 3 Study of Oral Ibrexafungerp (SCY-078) Vs. Placebo in Subjects With Recurrent Vulvovaginal Candidiasis (VVC)
Baseline characteristics by cohort
| Measure |
Ibrexafungerp
n=130 Participants
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
|
Placebo
n=130 Participants
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
|
Total
n=260 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
129 Participants
n=93 Participants
|
130 Participants
n=4 Participants
|
259 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Age, Continuous
|
34.1 years
STANDARD_DEVIATION 10.23 • n=93 Participants
|
33.7 years
STANDARD_DEVIATION 9.29 • n=4 Participants
|
33.9 years
STANDARD_DEVIATION 9.76 • n=27 Participants
|
|
Sex: Female, Male
Female
|
130 Participants
n=93 Participants
|
130 Participants
n=4 Participants
|
260 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
12 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
22 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
118 Participants
n=93 Participants
|
120 Participants
n=4 Participants
|
238 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
21 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
120 Participants
n=93 Participants
|
114 Participants
n=4 Participants
|
234 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
42 Participants
n=93 Participants
|
43 Participants
n=4 Participants
|
85 Participants
n=27 Participants
|
|
Region of Enrollment
Bulgaria
|
37 Participants
n=93 Participants
|
35 Participants
n=4 Participants
|
72 Participants
n=27 Participants
|
|
Region of Enrollment
Poland
|
17 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
31 Participants
n=27 Participants
|
|
Region of Enrollment
Russia
|
34 Participants
n=93 Participants
|
38 Participants
n=4 Participants
|
72 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Week 24Population: Intent-to-Treat Set
Efficacy as measured by the percentage of subjects with documented Clinical Success.
Outcome measures
| Measure |
Ibrexafungerp
n=130 Participants
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
|
Placebo
n=130 Participants
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
|
|---|---|---|
|
Clinical Success
Clinical Success
|
85 Participants
|
69 Participants
|
|
Clinical Success
Clinical Failure
|
45 Participants
|
61 Participants
|
SECONDARY outcome
Timeframe: Week 24Population: Intent-to-Treat Set
Efficacy as measured by the percentage of subjects with no Mycologically Proven Recurrence
Outcome measures
| Measure |
Ibrexafungerp
n=130 Participants
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
|
Placebo
n=130 Participants
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
|
|---|---|---|
|
The Percentage of Subjects With no Mycologically Proven Recurrence
No Mycologically Proven Recurrence
|
92 Participants
|
76 Participants
|
|
The Percentage of Subjects With no Mycologically Proven Recurrence
Mycologically Proven Recurrence
|
38 Participants
|
54 Participants
|
SECONDARY outcome
Timeframe: Week 24Population: Safety Population
Safety as measured by the number of subjects who discontinue due to treatment related adverse events.
Outcome measures
| Measure |
Ibrexafungerp
n=130 Participants
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
|
Placebo
n=130 Participants
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
|
|---|---|---|
|
Safety and Tolerability
|
0 Participants
|
1 Participants
|
Adverse Events
Ibrexafungerp
Serious events: 1 serious events
Other events: 66 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 41 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ibrexafungerp
n=130 participants at risk
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
|
Placebo
n=130 participants at risk
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
|
|---|---|---|
|
Infections and infestations
COVID-19
|
0.77%
1/130 • up to 38 weeks
|
0.00%
0/130 • up to 38 weeks
|
|
Infections and infestations
Influenza
|
0.77%
1/130 • up to 38 weeks
|
0.00%
0/130 • up to 38 weeks
|
Other adverse events
| Measure |
Ibrexafungerp
n=130 participants at risk
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
|
Placebo
n=130 participants at risk
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
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
7.7%
10/130 • up to 38 weeks
|
3.8%
5/130 • up to 38 weeks
|
|
Gastrointestinal disorders
Nausea
|
5.4%
7/130 • up to 38 weeks
|
3.8%
5/130 • up to 38 weeks
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.4%
7/130 • up to 38 weeks
|
3.1%
4/130 • up to 38 weeks
|
|
Infections and infestations
Bacterial vaginosis
|
7.7%
10/130 • up to 38 weeks
|
8.5%
11/130 • up to 38 weeks
|
|
Infections and infestations
COVID-19
|
5.4%
7/130 • up to 38 weeks
|
3.8%
5/130 • up to 38 weeks
|
|
Nervous system disorders
Headache
|
19.2%
25/130 • up to 38 weeks
|
8.5%
11/130 • up to 38 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place