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NCT03059992 · ClinicalTrials.gov registry record · Phase 3
Study to Evaluate the Efficacy and Safety of Ibrexafungerp in Patients With Fungal Diseases That Are Refractory to or Intolerant of Standard Antifungal Treatment
A Phase 3 study of Invasive Candidiasis and Coccidioidomycosis, sponsored by Scynexis.
- Completed
- Registry status
- Phase 3
- Development phase
- 233
- Enrollment target
- 20
- Study locations
NCT03059992: Completed Phase 3 study of Invasive Candidiasis and Coccidioidomycosis, sponsored by Scynexis.
NCT03059992 is a Phase 3 study of Invasive Candidiasis and Coccidioidomycosis that has completed, run by Scynexis. The registered enrollment target is 233 participants, below the 264-participant average among 5 other Invasive Candidiasis trials with a reported enrollment target (12% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03059992, a Phase 3 study of Invasive Candidiasis and Coccidioidomycosis, has completed, sponsored by Scynexis.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 233 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a multicenter, open label, non-comparator, single arm study to evaluate the efficacy and safety of ibrexafungerp (SCY-078) in patients ≥ 18 years of age with a documented fungal disease that has been intolerant or refractory (rIFI) to Standard of Care (SoC) antifungal treatment.
Primary Outcome
The percentage of participants who achieve Global Response (defined as complete or partial response) as determined by the DRC at disease specific timepoints by fungal disease. Global Response is measured by participant survival and overall effect of treatment on the disease. Complete response: Survival, all attributable signs/symptoms (including radiological) resolved and myoclogical eradication of disease; Partial response: Survival, improvement of attributable signs/symptoms (including radiolo
Conditions Studied
Interventions
- DRUG Ibrexafungerp
Study Locations (20)
New York
- Memorial Sloan Kettering Cancer Center - New York
- Weill Cornell Medical College - New York
- Stony Brook University Medical Center - Stony Brook
California
- UC Davis Medical Center - Sacramento
- University of California San Francisco - San Francisco
Georgia
- Emory University Hospital Midtown - Atlanta
- Augusta University - Augusta
Michigan
- University of Michigan - Ann Arbor
- Wayne State University - Detroit
Minnesota
- University of Minnesota - Minneapolis
- Mayo Clinic - Rochester
North Carolina
- Duke University Medical Center - Durham
- Wake Forest Baptist Medical Center - Winston-Salem
Texas
- University of Texas Southwestern Medical Center Dallas - Dallas
- University of Texas Health Science Center at Houston - Houston
Alabama
- University of Alabama at Birmingham - Birmingham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 233 participants |
| Start Date | 2017-04-01 |
| Est. Completion | 2023-08-25 |
| Phase | Phase 3 |
What the finished NCT03059992 record still lists
NCT03059992 is an interventional study that assigns participants to a tested intervention. The registered 233 participants enrollment target is mid-sized for trials with a published cap, below the 264-participant average among 5 other Invasive Candidiasis trials with a reported enrollment target (12% lower).
The record links to 10 conditions, with Invasive Candidiasis appearing as the primary indexed condition, and to 1 intervention - of which Ibrexafungerp is the first listed.
NCT03059992 names 20 study sites across 12 states, led by New York, California, Georgia.
Frequently Asked Questions
What is clinical trial NCT03059992 about?
NCT03059992 is a clinical study titled "Study to Evaluate the Efficacy and Safety of Ibrexafungerp in Patients With Fungal Diseases That Are Refractory to or Intolerant of Standard Antifungal Treatment". This is a multicenter, open label, non-comparator, single arm study to evaluate the efficacy and safety of ibrexafungerp (SCY-078) in patients ≥ 18 years of age with a documented fungal disease that has been intolerant or refractory (rIFI) to Standard of Care (SoC) antifungal treatment.
What is the current status of trial NCT03059992?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 233 participants. The study started on 2017-04-01. Estimated completion is 2023-08-25.
What conditions does trial NCT03059992 study?
This clinical trial studies the following conditions: Invasive Candidiasis, Coccidioidomycosis, Histoplasmosis, Invasive Pulmonary Aspergillosis, Mucocutaneous Candidiasis.
What interventions are being tested in trial NCT03059992?
The interventions under investigation include: Ibrexafungerp (DRUG).
Who is sponsoring clinical trial NCT03059992?
This trial is sponsored by Scynexis, which has 13 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03059992 being conducted?
This trial has 20 study locations across Alabama, California, Georgia, Massachusetts, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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