NCT03059992

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

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 233 (actual)
• Sponsor: Scynexis, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

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

Interventions

Type	Name	Description
DRUG	Ibrexafungerp	Experimental Study Drug

Timeline

• Start date: 2017-04-01
• Primary completion: 2023-08-25
• Completion: 2023-08-25
• First posted: 2017-02-23
• Last updated: 2024-11-20
• Results posted: 2024-11-20

Locations

37 sites across 8 countries: United States, Austria, Germany, Netherlands, Pakistan, South Africa, Spain, United Kingdom

Regulatory

• FDA-regulated drug study