drugset
drugset / Trial / NCT05178862

A Phase 3, Randomized, Double-blind Study for Patients With Invasive Candidiasis Treated With IV Echinocandin Followed by Either Oral Ibrexafungerp or Oral Fluconazole

NCT05178862 ↗

Phase 3 Terminated 68 enrolled Scynexis, Inc.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a multicenter, randomized, double-blind study of two treatment regimens for invasive candidiasis included candidemia. Subjects will receive intravenous echinocandin followed by oral ibrexafungerp (SCY-078) vs intravenous echinocandin followed by oral fluconazole.

Timeline

Start
2022-08-03
Primary completion
2025-11-07
Completion
2025-12-16

Outcome

Outcome not reported

Stopped: “Termination is not related to safety or efficacy concerns for Ibrexafungerp. GSK's decision is to focus efforts and resources on commercialization of Ibrexafungerp for the already approved VVC and rVVC indications.”

Drugs

EvaluationDrugModalityDoseRoute
Comparator Fluconazole Small molecule — Oral
Subject Ibrexafungerp Small molecule — Oral
Background Anidulafungin Other / unclassified — Intravenous
Background Caspofungin Other / unclassified — Intravenous
Background Micafungin Peptide — Intravenous

Indications

candidemia