NCT03672292

Evaluate Safety and Efficacy of the Coadministration of Ibrexafungerp With Voriconazole in Patients With Invasive Pulmonary Aspergillosis

A Multicenter, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of the Coadministration of SCY-078 With Voriconazole in Patients With Invasive Pulmonary Aspergillosis

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Scynexis, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Study to evaluate the safety and efficacy of coadminstration of SCY-078 with a mold-active azole (voriconazole) compared to voriconazole in patients with invasive pulmonary aspergillosis.

Detailed description

This is a multicenter, randomized, double-blind, two-arm study to evaluate the safety, tolerability, efficacy and PK of the coadministration of SCY-078 plus voriconazole compared to those of voriconazole in male and female subjects 18 years of age and older with a probable or proven invasive pulmonary aspergillosis.

Conditions

• Invasive Pulmonary Aspergillosis

Interventions

Type	Name	Description
DRUG	SCY-078	Oral tablets of SCY-078
DRUG	Voriconazole	Voriconazole IV vials or oral tablets
OTHER	Oral Placebo Tablets	Oral Placebo Tablets matching SCY-078

Timeline

• Start date: 2019-01-22
• Primary completion: 2023-03-27
• Completion: 2023-03-27
• First posted: 2018-09-14
• Last updated: 2024-08-09
• Results posted: 2024-08-09

Locations

8 sites across 5 countries: United States, Belgium, Canada, Germany, South Africa

Regulatory

• FDA-regulated drug study