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

Study Overview
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Brief Summary
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To assess the efficacy of nebulized PC945 in combination with systemic antifungal therapy for the treatment of refractory IPA

Official Title
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A Double-blind, Randomized, Placebo-controlled Study to Assess the Safety and Efficacy of Nebulized PC945 When Added to Systemic Antifungal Therapy for the Treatment of Refractory Invasive Pulmonary Aspergillosis (OPERA-T Study)

Conditions
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Refractory IPA

Intervention / Treatment
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* Drug: PC945
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participant has proven or probable IPA according to the 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. Participant's IPA has an unfavorable response to adequate antifungal therapy. Exclusion Criteria: 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. Participant who has previously received PC945. Participant with a known history of allergy, hypersensitivity, or any previous serious reaction to any component of the PC945 or placebo formulations. Participant who is participating, or who is due to participate at any time during the study, in a therapeutic or diagnostic clinical trial.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PC945<br>PC945 dose, administered via nebulizer, twice daily | Drug: PC945<br>* Sterile aqueous liquid for Nebulization<br>|
| Placebo Comparator: Placebo<br>PC945-placebo administered via nebulizer, twice daily | Drug: Placebo<br>* Sterile aqueous liquid for Nebulization<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Complete or Partial Overall Response |  | up to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Complete or Partial Overall Clinical Response |  | up to 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Refractory IPA, invasive pulmonary aspergillosis