Trial Outcomes & Findings for Open-Label Study to Evaluate the Efficacy and Safety of Oral Ibrexafungerp (SCY-078) in Patients With Candidiasis Caused by Candida Auris (CARES) (NCT NCT03363841)
NCT ID: NCT03363841
Last Updated: 2024-07-03
Results Overview
The percentage of participants with global success at End of Treatment (EoT) as determined by the Data Monitoring Committee. Global success is defined as complete or partial resolution of signs and symptoms associated with the fungal disease and mycological eradication.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
30 participants
Primary outcome timeframe
At (EoT) Visit (up to 90 days after Day 1)
Results posted on
2024-07-03
Participant Flow
Of the 34 Participants Screened, 30 met the selection criteria for the study
Participant milestones
| Measure |
SCY-078
SCY-078
SCY-078: Oral SCY-078
|
|---|---|
|
Overall Study
STARTED
|
30
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
10
|
Reasons for withdrawal
| Measure |
SCY-078
SCY-078
SCY-078: Oral SCY-078
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Death
|
7
|
|
Overall Study
Physician Decision
|
1
|
Baseline Characteristics
Open-Label Study to Evaluate the Efficacy and Safety of Oral Ibrexafungerp (SCY-078) in Patients With Candidiasis Caused by Candida Auris (CARES)
Baseline characteristics by cohort
| Measure |
Ibrexafungerp 750 mg
n=30 Participants
Oral ibrexafungerp was to be given as 750 mg BID (total daily dose = 1500 mg) on Days 1 and 2, followed by oral ibrexafungerp 750 mg QD (total daily dose = 750 mg) from Day 3 onwards for up to 90 days
|
|---|---|
|
Age, Continuous
|
60.3 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At (EoT) Visit (up to 90 days after Day 1)Population: Intent to Treat Population (ITT): all subjects who were enrolled in the study
The percentage of participants with global success at End of Treatment (EoT) as determined by the Data Monitoring Committee. Global success is defined as complete or partial resolution of signs and symptoms associated with the fungal disease and mycological eradication.
Outcome measures
| Measure |
Ibrexafungerp 750mg
n=30 Participants
Oral ibrexafungerp was to be given as 750 mg BID (total daily dose = 1500 mg) on Days 1 and 2, followed by oral ibrexafungerp 750 mg QD (total daily dose = 750 mg) from Day 3 onwards for up to 90 days
|
|---|---|
|
Percentage of Participants With Global Success at End of Treatment as Determined by the Data Monitoring Committee
|
21 Participants
|
SECONDARY outcome
Timeframe: Through study completion, up to 132 daysPopulation: Safety Population: any participant that received at least one dose of study medication and had at least one safety assessment post-baseline
Percent of participants with treatment-emergent Adverse Events (TEAEs)
Outcome measures
| Measure |
Ibrexafungerp 750mg
n=30 Participants
Oral ibrexafungerp was to be given as 750 mg BID (total daily dose = 1500 mg) on Days 1 and 2, followed by oral ibrexafungerp 750 mg QD (total daily dose = 750 mg) from Day 3 onwards for up to 90 days
|
|---|---|
|
Percent of Participants With Treatment-emergent Adverse Events
|
25 Participants
|
SECONDARY outcome
Timeframe: Through study completion (up to 132 Days)Population: Safety Population - any participant that received at least one dose of study medication and had at least one safety assessment post-baseline
Number of participants with Discontinuations due to Adverse Events
Outcome measures
| Measure |
Ibrexafungerp 750mg
n=30 Participants
Oral ibrexafungerp was to be given as 750 mg BID (total daily dose = 1500 mg) on Days 1 and 2, followed by oral ibrexafungerp 750 mg QD (total daily dose = 750 mg) from Day 3 onwards for up to 90 days
|
|---|---|
|
Number of Participants Discontinued Due to Adverse Events
|
1 Participants
|
SECONDARY outcome
Timeframe: 42 Days after the End of Treatment visitPopulation: Participants in the Intent to Treat Population with Global Success at End of Treatment
The percentage of participants with a recurrence of the baseline fungal infection at the 6 week follow-up
Outcome measures
| Measure |
Ibrexafungerp 750mg
n=21 Participants
Oral ibrexafungerp was to be given as 750 mg BID (total daily dose = 1500 mg) on Days 1 and 2, followed by oral ibrexafungerp 750 mg QD (total daily dose = 750 mg) from Day 3 onwards for up to 90 days
|
|---|---|
|
Percentage of Participants With Recurrence of Baseline Fungal Infection
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 42 and Day 84 after first dose of study drugPopulation: Intent to Treat Population (ITT): all subjects who were enrolled in the study
Percentage of participants Surviving at Day 42 and Day 84 after Day 1 (first dose of study drug)
Outcome measures
| Measure |
Ibrexafungerp 750mg
n=30 Participants
Oral ibrexafungerp was to be given as 750 mg BID (total daily dose = 1500 mg) on Days 1 and 2, followed by oral ibrexafungerp 750 mg QD (total daily dose = 750 mg) from Day 3 onwards for up to 90 days
|
|---|---|
|
Percentage of Participants Surviving 42 and 84 Days
Day 84 · Died
|
8 Participants
|
|
Percentage of Participants Surviving 42 and 84 Days
Day 84 · Unknown survival status
|
3 Participants
|
|
Percentage of Participants Surviving 42 and 84 Days
Day 42 · Survived
|
24 Participants
|
|
Percentage of Participants Surviving 42 and 84 Days
Day 42 · Died
|
4 Participants
|
|
Percentage of Participants Surviving 42 and 84 Days
Day 42 · Unknown survival status
|
2 Participants
|
|
Percentage of Participants Surviving 42 and 84 Days
Day 84 · Survived
|
19 Participants
|
Adverse Events
Ibrexafungerp 750mg
Serious events: 11 serious events
Other events: 25 other events
Deaths: 8 deaths
Serious adverse events
| Measure |
Ibrexafungerp 750mg
n=30 participants at risk
Single Arm: Oral ibrexafungerp was to be given as 750 mg BID (total daily dose = 1500 mg) on Days 1 and 2, followed by oral ibrexafungerp 750 mg QD (total daily dose = 750 mg) from Day 3 onwards for up to 90 days
|
|---|---|
|
Infections and infestations
Abdominal sepsis
|
3.3%
1/30 • From signing of Informed Consent to Week 6 follow up (up to 132 Days)
|
|
Infections and infestations
COVID-19 Pneumonia
|
3.3%
1/30 • From signing of Informed Consent to Week 6 follow up (up to 132 Days)
|
|
Infections and infestations
Intervertebral discitis
|
3.3%
1/30 • From signing of Informed Consent to Week 6 follow up (up to 132 Days)
|
|
Infections and infestations
Pneumonia
|
3.3%
1/30 • From signing of Informed Consent to Week 6 follow up (up to 132 Days)
|
|
Infections and infestations
Septic shock
|
3.3%
1/30 • From signing of Informed Consent to Week 6 follow up (up to 132 Days)
|
|
Infections and infestations
Systemic Candida
|
3.3%
1/30 • From signing of Informed Consent to Week 6 follow up (up to 132 Days)
|
|
General disorders
Multiple organ dysfunction syndrome
|
6.7%
2/30 • From signing of Informed Consent to Week 6 follow up (up to 132 Days)
|
|
General disorders
Chest pain
|
3.3%
1/30 • From signing of Informed Consent to Week 6 follow up (up to 132 Days)
|
|
General disorders
Oedema peripheral
|
3.3%
1/30 • From signing of Informed Consent to Week 6 follow up (up to 132 Days)
|
|
Renal and urinary disorders
Acute kidney injury
|
6.7%
2/30 • From signing of Informed Consent to Week 6 follow up (up to 132 Days)
|
|
Gastrointestinal disorders
Hematemesis
|
3.3%
1/30 • From signing of Informed Consent to Week 6 follow up (up to 132 Days)
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
3.3%
1/30 • From signing of Informed Consent to Week 6 follow up (up to 132 Days)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.3%
1/30 • From signing of Informed Consent to Week 6 follow up (up to 132 Days)
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
3.3%
1/30 • From signing of Informed Consent to Week 6 follow up (up to 132 Days)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
3.3%
1/30 • From signing of Informed Consent to Week 6 follow up (up to 132 Days)
|
|
Gastrointestinal disorders
Abdominal pain
|
3.3%
1/30 • From signing of Informed Consent to Week 6 follow up (up to 132 Days)
|
|
Gastrointestinal disorders
Large intestine perforation
|
3.3%
1/30 • From signing of Informed Consent to Week 6 follow up (up to 132 Days)
|
|
Gastrointestinal disorders
Volvulus of small bowel
|
3.3%
1/30 • From signing of Informed Consent to Week 6 follow up (up to 132 Days)
|
|
Gastrointestinal disorders
Vomiting
|
3.3%
1/30 • From signing of Informed Consent to Week 6 follow up (up to 132 Days)
|
|
Nervous system disorders
Hepatic encephalopathy
|
3.3%
1/30 • From signing of Informed Consent to Week 6 follow up (up to 132 Days)
|
|
Nervous system disorders
Syncope
|
3.3%
1/30 • From signing of Informed Consent to Week 6 follow up (up to 132 Days)
|
|
Cardiac disorders
Cardio-respiratory arrest
|
3.3%
1/30 • From signing of Informed Consent to Week 6 follow up (up to 132 Days)
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
3.3%
1/30 • From signing of Informed Consent to Week 6 follow up (up to 132 Days)
|
Other adverse events
| Measure |
Ibrexafungerp 750mg
n=30 participants at risk
Single Arm: Oral ibrexafungerp was to be given as 750 mg BID (total daily dose = 1500 mg) on Days 1 and 2, followed by oral ibrexafungerp 750 mg QD (total daily dose = 750 mg) from Day 3 onwards for up to 90 days
|
|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
36.7%
11/30 • From signing of Informed Consent to Week 6 follow up (up to 132 Days)
|
|
Gastrointestinal disorders
Nausea
|
23.3%
7/30 • From signing of Informed Consent to Week 6 follow up (up to 132 Days)
|
|
Gastrointestinal disorders
Vomiting
|
13.3%
4/30 • From signing of Informed Consent to Week 6 follow up (up to 132 Days)
|
|
Gastrointestinal disorders
Constipation
|
10.0%
3/30 • From signing of Informed Consent to Week 6 follow up (up to 132 Days)
|
|
Gastrointestinal disorders
Dyspepsia
|
10.0%
3/30 • From signing of Informed Consent to Week 6 follow up (up to 132 Days)
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
6.7%
2/30 • From signing of Informed Consent to Week 6 follow up (up to 132 Days)
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
6.7%
2/30 • From signing of Informed Consent to Week 6 follow up (up to 132 Days)
|
|
Investigations
Blood potassium increased
|
6.7%
2/30 • From signing of Informed Consent to Week 6 follow up (up to 132 Days)
|
|
Investigations
Escherichia test positive
|
6.7%
2/30 • From signing of Informed Consent to Week 6 follow up (up to 132 Days)
|
|
Investigations
Liver function test abnormal
|
6.7%
2/30 • From signing of Informed Consent to Week 6 follow up (up to 132 Days)
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
10.0%
3/30 • From signing of Informed Consent to Week 6 follow up (up to 132 Days)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
6.7%
2/30 • From signing of Informed Consent to Week 6 follow up (up to 132 Days)
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
6.7%
2/30 • From signing of Informed Consent to Week 6 follow up (up to 132 Days)
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
6.7%
2/30 • From signing of Informed Consent to Week 6 follow up (up to 132 Days)
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
6.7%
2/30 • From signing of Informed Consent to Week 6 follow up (up to 132 Days)
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
6.7%
2/30 • From signing of Informed Consent to Week 6 follow up (up to 132 Days)
|
|
Infections and infestations
Candida infection
|
13.3%
4/30 • From signing of Informed Consent to Week 6 follow up (up to 132 Days)
|
|
Infections and infestations
Pneumonia
|
6.7%
2/30 • From signing of Informed Consent to Week 6 follow up (up to 132 Days)
|
|
Infections and infestations
Pneumonia klebsiella
|
6.7%
2/30 • From signing of Informed Consent to Week 6 follow up (up to 132 Days)
|
|
Infections and infestations
Septic shock
|
6.7%
2/30 • From signing of Informed Consent to Week 6 follow up (up to 132 Days)
|
|
Infections and infestations
Urinary tract infection
|
6.7%
2/30 • From signing of Informed Consent to Week 6 follow up (up to 132 Days)
|
|
Vascular disorders
Hypotension
|
10.0%
3/30 • From signing of Informed Consent to Week 6 follow up (up to 132 Days)
|
|
Vascular disorders
Hypertension
|
6.7%
2/30 • From signing of Informed Consent to Week 6 follow up (up to 132 Days)
|
|
Nervous system disorders
Seizure
|
6.7%
2/30 • From signing of Informed Consent to Week 6 follow up (up to 132 Days)
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
10.0%
3/30 • From signing of Informed Consent to Week 6 follow up (up to 132 Days)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
6.7%
2/30 • From signing of Informed Consent to Week 6 follow up (up to 132 Days)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
6.7%
2/30 • From signing of Informed Consent to Week 6 follow up (up to 132 Days)
|
|
Blood and lymphatic system disorders
Anaemia
|
10.0%
3/30 • From signing of Informed Consent to Week 6 follow up (up to 132 Days)
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
6.7%
2/30 • From signing of Informed Consent to Week 6 follow up (up to 132 Days)
|
|
Cardiac disorders
Bradycardia
|
6.7%
2/30 • From signing of Informed Consent to Week 6 follow up (up to 132 Days)
|
|
Cardiac disorders
Tachycardia
|
6.7%
2/30 • From signing of Informed Consent to Week 6 follow up (up to 132 Days)
|
|
General disorders
Pyrexia
|
10.0%
3/30 • From signing of Informed Consent to Week 6 follow up (up to 132 Days)
|
|
General disorders
Multiple organ dysfunction syndrome
|
6.7%
2/30 • From signing of Informed Consent to Week 6 follow up (up to 132 Days)
|
|
General disorders
Pain
|
6.7%
2/30 • From signing of Informed Consent to Week 6 follow up (up to 132 Days)
|
|
Renal and urinary disorders
Acute kidney injury
|
6.7%
2/30 • From signing of Informed Consent to Week 6 follow up (up to 132 Days)
|
|
Psychiatric disorders
Insomnia
|
6.7%
2/30 • From signing of Informed Consent to Week 6 follow up (up to 132 Days)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place