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NCT03363841 · ClinicalTrials.gov registry record · Phase 3
Open-Label Study to Evaluate the Efficacy and Safety of Oral Ibrexafungerp (SCY-078) in Patients With Candidiasis Caused by Candida Auris (CARES)
A Phase 3 study, sponsored by Scynexis.
- Completed
- Registry status
- Phase 3
- Development phase
- 30
- Enrollment target
NCT03363841: Completed Phase 3 study, sponsored by Scynexis.
NCT03363841 is a Phase 3 study that has completed, run by Scynexis. The registered enrollment target is 30 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03363841, a Phase 3 study, has completed, sponsored by Scynexis.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 30 participants
- Enrollment target
Study Summary
This is a multicenter, open-label, non-comparator, single-arm study to evaluate the efficacy, safety, tolerability and PK (pharmacokinetics) of oral SCY-078 as an emergency use treatment for patients with a documented Candida auris infection.
Primary Outcome
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.
Interventions
- DRUG SCY-078
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2017-11-15 |
| Est. Completion | 2023-05-24 |
| Phase | Phase 3 |
What the finished NCT03363841 record still lists
NCT03363841 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 1 intervention - of which SCY-078 is the first listed.
NCT03363841 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03363841 about?
NCT03363841 is a clinical study titled "Open-Label Study to Evaluate the Efficacy and Safety of Oral Ibrexafungerp (SCY-078) in Patients With Candidiasis Caused by Candida Auris (CARES)". This is a multicenter, open-label, non-comparator, single-arm study to evaluate the efficacy, safety, tolerability and PK (pharmacokinetics) of oral SCY-078 as an emergency use treatment for patients with a documented Candida auris infection.
What is the current status of trial NCT03363841?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 30 participants. The study started on 2017-11-15. Estimated completion is 2023-05-24.
What interventions are being tested in trial NCT03363841?
The interventions under investigation include: SCY-078 (DRUG).
Who is sponsoring clinical trial NCT03363841?
This trial is sponsored by Scynexis, which has 13 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03363841's enrollment target sits among peer trials
30 1917th of 2000 higher than 68 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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