Study to Evaluate the Efficacy and Safety of Ibrexafungerp in Patients With Fungal Diseases That Are Refractory to or Intolerant of Standard Antifungal Treatment — FURI  

Invasive Candidiasis Clinical Trial

Official title: Open-Label Study to Evaluate the Efficacy and Safety of SCY-078 (Ibrexafungerp) in Patients With Fungal Diseases That Are Refractory to or Intolerant of Standard Antifungal Treatment (FURI)

Status Completed

Clinical Trial 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.

Clinical Trial Description

This is a multicenter, open label, non-comparator, single arm study to evaluate the efficacy and safety of ibrexafungerp 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 ibrexafungerp for up to 180 days. Treatment beyond 180 days and combination therapy with other antifungal agents may be allowed under special circumstances to be agreed upon by the Investigator and the Sponsor.

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 15 treatment visits, a follow-up visit and 2 follow-up contacts. ;

Related Conditions & MeSH terms

• Allergic Bronchopulmonary Aspergillosis
• Aspergillosis
• Blastomycosis
• Candidiasis
• Candidiasis, Chronic Mucocutaneous
• Candidiasis, Invasive
• Candidiasis, Vulvovaginal
• Chronic Pulmonary Aspergillosis
• Coccidioidomycosis
• Histoplasmosis
• Invasive Candidiasis
• Invasive Pulmonary Aspergillosis
• Mucocutaneous Candidiasis
• Mycoses
• Other Emerging Fungi
• Pulmonary Aspergillosis
• Recurrent Vulvovaginal Candidiasis

• NCT number: NCT03059992
• Study type: Interventional
• Source: Scynexis, Inc.
• Status: Completed
• Phase: Phase 3
• Start date: April 1, 2017
• Completion date: August 17, 2023