Open-Label Study to Evaluate the Efficacy and Safety of Oral Ibrexafungerp (SCY-078) in Patients With Candidiasis Caused by Candida Auris (CARES)

Study Overview
=================
Brief 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.

Detailed Description
-----------------
This is a multicenter, open-label, non-comparator, single-arm study to evaluate the efficacy, safety, tolerability and PK (for a subset of subjects) of oral SCY-078 in male and female subjects ≥18 years of age with a documented Candida auris infection. Patients will be treated with SCY-078 for up to 90 days. Subjects must have a documented candidiasis, including candidemia, caused by Candida auris to be considered for enrollment. Subjects are also eligible if they are receiving intravenous (IV) antifungal therapy for their C. auris infection and, in the judgment of the investigator, continued IV antifungal therapy is not feasible or desirable due to clinical or logistical circumstances. Subjects must meet all study criteria to be eligible for inclusion. Inclusion of each subject in the study must be approved by the Sponsor prior to enrollment. Following a screening visit , there will be up to 11 treatment visits, a follow-up visit and 2 follow-up contacts (survival visits)

Official Title
-----------------
Open-Label Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of Oral Ibrexafungerp (SCY-078) as an Emergency Use Treatment for Patients With Candidiasis, Including Candidemia, Caused by Candida Auris

Conditions
-----------------
Candidiasis, Invasive, Candidemia

Intervention / Treatment
-----------------
* Drug: SCY-078


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject must fulfill the following KEY criteria to be eligible for study admission: Subject is a male or female adult ≥ 18 years of age on the day the study informed consent form (ICF) is signed. Subject has a documented candidiasis, including candidemia, caused by Candida auris. The subject is also eligible if he/she is receiving IV antifungal therapy for their C. auris infection and, in the judgment of the investigator, long-term IV antifungal therapy is not feasible or desirable due to clinical or logistical circumstances. A documented candidiasis, including candidemia, caused by Candida auris is defined as the recovery of Candida auris by culture of a sample obtained within the last 7 days. Subject is able to tolerate medication orally or through a nasogastric (NG) tube or percutaneous endoscopic gastrostomy (PEG) tube. Exclusion Criteria: KEY exclusion criteria: Subject has a fungal disease with central nervous system involvement. Subject has a fungal disease of the bone and/or joint that is expected to require >90 days of study drug treatment. Subject has an inappropriately controlled fungal infection source (e.g., persistent catheters, devices, identified abscess) that is likely the source of the fungal infection. Subject is hemodynamically unstable and/or requiring vasopressor medication for blood pressure support. Subject has abnormal liver test parameters: AST or ALT >10 x ULN, and/or total bilirubin >5 x ULN. Note: Subjects with unconjugated hyperbilirubinemia with diagnosis of Gilbert's disease are not excluded. Subject has an Apache score >16. Subject has serum creatinine >3 times from Baseline (Screening/Treatment Day 1) value.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: non comparator, single arm
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SCY-078<br>SCY-078 | Drug: SCY-078<br>* Oral SCY-078<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy as measured by the percentage of subjects with global success at end of treatment | Efficacy as measured by the percentage of subjects with global success (complete or partial global response) at EoT as determined by the Data Monitoring Committee | Up to 90 days of study treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with treatment-related Adverse Events (Safety) | Number of participants with Adverse Events that are related to treatment | Through study completion, an average of 132 days | 
| Number of participants with Discontinuations due to Adverse Events (Safety) | Number of participants with Discontinuations due to Adverse Events | Through study completion, an average of 132 days | 
| Recurrence of Baseline Fungal Infection (Efficacy) | Assessment of Recurrence of Baseline Fungal Infection The proportion of subjects with a recurrence of the baseline fungal infection | up to 42 days after end of study treatment | 
| Survival (Safety and Efficacy) | Proportion of surviving subjects | Day 42 and Day 84 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Candida auris