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

> **NCT05238116** · PHASE3 · TERMINATED · sponsor: **Pulmocide Ltd** · enrollment: 85 (actual)

## Conditions studied

- Refractory IPA

## Interventions

- **DRUG:** PC945
- **DRUG:** Placebo

## Key facts

- **NCT ID:** NCT05238116
- **Lead sponsor:** Pulmocide Ltd
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** TERMINATED
- **Start date:** 2022-06-14
- **Primary completion:** 2025-12-29
- **Final completion:** 2025-12-29
- **Target enrollment:** 85 (ACTUAL)
- **Why 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.
- **Last updated:** 2026-04-30


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT05238116

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT05238116, "Safety and Efficacy of PC945 (Opelconazole) in Combination With Other Antifungal Therapy for the Treatment of Refractory Invasive Pulmonary Aspergillosis (OPERA-T Study)". Retrieved via AI Analytics 2026-06-08 from https://api.ai-analytics.org/clinical/NCT05238116. Licensed CC0.

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