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

Recruiting

• Conditions: Refractory IPA
• Interventions: Drug: Placebo; Drug: PC945

• Registration Number: NCT05238116
• Lead Sponsor: Pulmocide Ltd

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-02-03
• Study First Submitted QC: 2022-02-11
• Study First Posted: 2022-02-14
• Study Start: 2022-06-14
• Status Verified: 2025-09
• Last Update Submitted: 2025-09-11
• Last Update Posted: 2025-09-12
• Primary Completion: 2026-03-30
• Study Completion: 2026-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 123

Inclusion Criteria

1. Participant has proven or probable IPA according to the modified 2019 European Organization for Research and Treatment of Cancer/ Mycoses Study Group Education and Research Consortium (EORTC/MSGERC) consensus definitions or according to the 2010 International Society for Heart and Lung Transplantation (ISHLT) consensus statements for the definitions of infections in cardiothoracic transplant recipients.
2. Participant's IPA has failed to respond to adequate antifungal therapy.

Exclusion Criteria

1. Participant with a known or suspected concomitant medical condition or post-surgery complication that, in the opinion of the Investigator, may jeopardize adherence to the protocol requirements or impede the accurate measurement of efficacy or may be an unacceptable additional risk to the Participant should he/she participate in the study.
2. Participant who has previously received PC945.
3. Participant with a known history of allergy, hypersensitivity, or any previous serious reaction to any component of the PC945 or placebo formulations.
4. Participant who has recently received, is receiving or due to receive at any time during the study, an investigational medicinal agent that does not have any regulatory approved indications. Subjects who are participating in any other trials e.g., Observational, diagnostic or using medications with an approved indication may be allowed to participate after consultation with the sponsor on an individual basis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	PC945-placebo administered via nebulizer, twice daily
PC945	PC945	PC945 dose, administered via nebulizer, twice daily

Primary Outcome Measures

Name	Time	Method
Number of Participants with Complete or Partial Overall Response	up to 12 weeks (Day 84)

Secondary Outcome Measures

Name	Time	Method
Time to Complete or Partial Overall Clinical Response	up to 12 weeks (Day 84)

Trial Locations

Locations (4)

Clinical Research Site; 🇬🇧 Manchester, United Kingdom

Clinical R Site; 🇺🇸 Los Angeles, California, United States

Clinical Research Site 1; 🇮🇳 Pune, Maharashtra, India

Clinical Research Site 2; 🇮🇳 Pune, Maharashtra, India