Safety and Efficacy of PC945 (Opelconazole) in Combination With Other Antifungal Therapy for the Treatment of Refractory Invasive Pulmonary Aspergillosis (OPERA-T Study)

Phase 3 Terminated 85 enrolled Pulmocide Ltd

RandomizedParallel-groupQuadruple-blindTreatment

Summary

To assess the safety and efficacy of nebulized PC945 in combination with systemic antifungal therapy for the treatment of refractory IPA

Timeline

Start: 2022-06-14
Primary completion: 2025-12-29
Completion: 2025-12-29

Outcome

Outcome not reported

Stopped: “The study was terminated by the Sponsor based on a sample size recalculation interim analysis which showed a numerically lower favorable response rate and a numerically higher mortality rate in the opelconazole arm compared to the control arm.”

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Opelconazole	Small molecule	—	Other

Indications

No indication recorded.