Trial · NCT03363841
Open-Label Study to Evaluate the Efficacy and Safety of Oral Ibrexafungerp (SCY-078) in Patients With Candidiasis Caused by Candida Auris (CARES)
NCT03363841, Phase 3, Completed, Scynexis, Inc.; results first posted 2024-07-03
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Open-Label Study to Evaluate the Efficacy and Safety of Oral Ibrexafungerp (SCY-078) in Patients With Candidiasis Caused by Candida Auris (CARES). Trials, record NCT03363841. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03363841
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Open-Label Study to Evaluate the Efficacy and Safety of Oral Ibrexafungerp (SCY-078) in Patients With Candidiasis Caused by Candida Auris (CARES)
- NCT number
- NCT03363841
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 30 participants, actual
- Lead sponsor
- Scynexis, Inc.
- Conditions
- Candidiasis, Invasive, Candidemia
- Interventions
- SCY-078
- First posted
- 2017-12-06
- Last updated
- 2024-07-03
- Results first posted
- 2024-07-03
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Global Success at End of Treatment as Determined by the Data Monitoring Committee | At (EoT) Visit (up to 90 days after Day 1) | 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. |
| Secondary | Percent of Participants With Treatment-emergent Adverse Events | Through study completion, up to 132 days | Percent of participants with treatment-emergent Adverse Events (TEAEs) |
| Secondary | Number of Participants Discontinued Due to Adverse Events | Through study completion (up to 132 Days) | Number of participants with Discontinuations due to Adverse Events |
| Secondary | Percentage of Participants With Recurrence of Baseline Fungal Infection | 42 Days after the End of Treatment visit | The percentage of participants with a recurrence of the baseline fungal infection at the 6 week follow-up |
| Secondary | Percentage of Participants Surviving 42 and 84 Days | Day 42 and Day 84 after first dose of study drug | Percentage of participants Surviving at Day 42 and Day 84 after Day 1 (first dose of study drug) |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Global Success at End of Treatment as Determined by the Data Monitoring Committee | At (EoT) Visit (up to 90 days after Day 1) | Intent to Treat Population (ITT): all subjects who were enrolled in the study | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percent of Participants With Treatment-emergent Adverse Events | Through study completion, up to 132 days | Safety Population: any participant that received at least one dose of study medication and had at least one safety assessment post-baseline | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Discontinued Due to Adverse Events | Through study completion (up to 132 Days) | Safety Population - any participant that received at least one dose of study medication and had at least one safety assessment post-baseline | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants With Recurrence of Baseline Fungal Infection | 42 Days after the End of Treatment visit | Participants in the Intent to Treat Population with Global Success at End of Treatment | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants Surviving 42 and 84 Days | Day 42 and Day 84 after first dose of study drug | Intent to Treat Population (ITT): all subjects who were enrolled in the study | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Global Success at End of Treatment as Determined by the Data Monitoring Committee | Ibrexafungerp 750mg | 21 | Participants | ||
| Percent of Participants With Treatment-emergent Adverse Events | Ibrexafungerp 750 mg | 25 | Participants | ||
| Number of Participants Discontinued Due to Adverse Events | Ibrexafungerp 750 mg | 1 | Participants | ||
| Percentage of Participants With Recurrence of Baseline Fungal Infection | Ibrexafungerp 750 mg | 1 | Participants | ||
| Percentage of Participants Surviving 42 and 84 Days | Ibrexafungerp 750 mg | Day 42 / Survived | 24 | Participants | |
| Percentage of Participants Surviving 42 and 84 Days | Ibrexafungerp 750 mg | Day 42 / Died | 4 | Participants | |
| Percentage of Participants Surviving 42 and 84 Days | Ibrexafungerp 750 mg | Day 42 / Unknown survival status | 2 | Participants | |
| Percentage of Participants Surviving 42 and 84 Days | Ibrexafungerp 750 mg | Day 84 / Survived | 19 | Participants | |
| Percentage of Participants Surviving 42 and 84 Days | Ibrexafungerp 750 mg | Day 84 / Died | 8 | Participants | |
| Percentage of Participants Surviving 42 and 84 Days | Ibrexafungerp 750 mg | Day 84 / Unknown survival status | 3 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | SCY-078 | 30 | |
| Overall Study | COMPLETED | SCY-078 | 20 | |
| Overall Study | NOT COMPLETED | SCY-078 | 10 |
Source ClinicalTrials.gov
Adverse events59
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | Ibrexafungerp 750mg | 11 | 30 | |
| other | Nausea | Gastrointestinal disorders | Ibrexafungerp 750mg | 7 | 30 | |
| other | Vomiting | Gastrointestinal disorders | Ibrexafungerp 750mg | 4 | 30 | |
| other | Constipation | Gastrointestinal disorders | Ibrexafungerp 750mg | 3 | 30 | |
| other | Dyspepsia | Gastrointestinal disorders | Ibrexafungerp 750mg | 3 | 30 | |
| other | Gastrointestinal haemorrhage | Gastrointestinal disorders | Ibrexafungerp 750mg | 2 | 30 | |
| other | Impaired gastric emptying | Gastrointestinal disorders | Ibrexafungerp 750mg | 2 | 30 | |
| other | Blood potassium increased | Investigations | Ibrexafungerp 750mg | 2 | 30 | |
| other | Escherichia test positive | Investigations | Ibrexafungerp 750mg | 2 | 30 | |
| other | Liver function test abnormal | Investigations | Ibrexafungerp 750mg | 2 | 30 |
1 to 10 of 59Source ClinicalTrials.gov
See all 59 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ibrexafungerp 750mg | 8 | 30 |
| Total, other adverse events | Ibrexafungerp 750mg | 25 | 30 |
| Total, serious adverse events | Ibrexafungerp 750mg | 11 | 30 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03363841
GET https://conductscience.org/api/trials/v1/NCT03363841/events?page=2