Open-Label Study to Evaluate Efficacy and Safety of SCY-078 in Patients With Refractory or Intolerant Fungal Diseases (FURI)

This is a multicenter, open label, non-comparator, single arm study to evaluate the efficacy and safety of 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.

Condition or disease Intervention/treatment Phase 
Invasive Candidiases Mucocutaneous CandidiasisDrug: SCY-078Phase 3

Detailed Description:

This is a multicenter, open label, non-comparator, single arm study to evaluate the efficacy and safety of SCY-078 in patients ≥ 18 years of age with a documented invasive and/or severe fungal disease that has been intolerant or refractory (rIFI) to Standard of Care (SoC) antifungal treatment. Patients will be treated with SCY-078 for up to 90 days.

Subjects must have a proven or probable fungal disease and meet all study criteria to be considered for enrollment. Eligible subjects must also have documented evidence of failure of, intolerance to, or toxicity related to a currently approved SoC antifungal treatment.

Subjects will also be considered for enrollment if they have an eligible fungal disease and, in the judgement of the investigator, the subject cannot receive approved oral antifungal options (e.g. susceptibility of the organism or risk for drug-drug interactions) and a continued IV antifungal therapy is not desirable or feasible due to clinical or logistical circumstances.

Following a screening visit, there will be up to 11 treatment visits, a follow-up visit and 2 follow-up contacts.

Antifungal name: 

Date of article/Start date of trial: 

Saturday, April 1, 2017

Trial phase: 

Phase 3

ClinicalTrials.gov ID: 

NCT03059992
New antifungal drugs