An Open-label Safety Study of PC945 (Opelconazole) Prophylaxis or Pre-emptive Therapy Against Pulmonary Aspergillosis in Lung Transplant Recipients (OPERA-S Study)

A Randomized Controlled Open-label Study to Assess the Safety and Tolerability of Nebulized PC945 for Prophylaxis or Pre-emptive Therapy Against Pulmonary Aspergillosis in Lung Transplant Recipients (OPERA-S Study)

A study to evaluate the safety and tolerability of opelconazole for the prevention of fungal aspergillus infections in the lung in participants who have received a lung transplant.

Study Overview

• Status: Completed
• Conditions: Pulmonary Aspergillosis
• Intervention / Treatment: Drug: Standard of Care; Drug: Opelconazole

Detailed Description

Part 1 of the study comprises a 12 week Prophylaxis or Pre-emptive Therapy Phase. Part 2 comprises a 4-week Safety Follow-Up Phase.

The study will screen single or double lung transplant recipients due to receive a mold-active antifungal: either as de novo prophylaxis or as pre-emptive therapy (for participants with Aspergillus spp. colonization of the respiratory tract but no evidence of pulmonary fungal disease). Only participants who fulfill all the inclusion and none of the exclusion criteria will be randomized.

• Study Type: Interventional
• Enrollment (Actual): 102
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Edmonton, Canada, T6G 1Z1
    • Clinical Research Site
  • Toronto, Canada, M5G 2N2
    • Clinical Research Site
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85013
      • Clinical Research Site
  • California
    • La Jolla, California, United States, 92037
      • Clinical Research Site
    • Los Angeles, California, United States, 90095
      • Clinical Research Site
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Clinical Research Site
    • Tampa, Florida, United States, 33606
      • Clinical Research Site
  • Illinois
    • Maywood, Illinois, United States, 60153
      • Clinical Research Site
  • Missouri
    • St Louis, Missouri, United States, 63110
      • Research Site
  • New York
    • New York, New York, United States, 10016
      • Clinical Research Site
    • The Bronx, New York, United States, 10467
      • Clinical Research Site
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Clinical Research Site
    • Philadelphia, Pennsylvania, United States, 19140
      • Clinical Research Site
    • Pittsburgh, Pennsylvania, United States, 15213
      • Clinical Research Site
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Clinical Research Site
  • Texas
    • Dallas, Texas, United States, 75246
      • Clinical Research Site
    • Houston, Texas, United States, 77030
      • Clinical Research Site 1
    • Houston, Texas, United States, 77030
      • Clinical Research Site 2
    • Houston, Texas, United States, 77030
      • Clinical Research Site 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Key Inclusion Criteria:

2. Participant has received either a single or double lung transplant but did not receive any other organ transplant (e.g., heart, kidney, etc.) at the time of the lung transplantation. History of prior transplant (>1 year) is acceptable

6a. (De novo prophylaxis immediately post transplant): participant must be ready to be randomized and start anti-mold prophylaxis within 72 hours of returning to the intensive care unit (ICU) after the transplant surgery or

6b. (Pre-emptive therapy): participant must meet all of the following:

• Aspergillus spp. colonization of the respiratory tract confirmed within 91 days (13 weeks) after a lung transplant. Colonization is defined according to the 2010 International Society for Heart Lung Transplantation (ISHLT) Consensus Statement definition criteria for colonization
• Without evidence of pulmonary fungal disease
• Must be ready to start anti-mold medication within 96 hours after the positive culture(s), galactomannan or polymerase chain reaction (PCR) result(s) were reported

Key Exclusion Criteria:

1. Participant would normally receive nebulized amphotericin B as the only mold active antifungal agent as initial SoC prophylaxis or pre-emptive therapy
2. Fungal disease requiring systemic antifungal treatment at the time of transplant
3. Has received a mold active antifungal agent post-transplant (Note: a participant who receives a mold active antifungal agent within 24 hours before, during, or after the transplant procedure will not be excluded if the mold active medication was stopped within 72 hours of returning to the ICU after the transplant surgery, or prior to randomization (whichever happens first)
4. Has previously received opelconazole
5. Is receiving, or who is due to receive at any time during the study, an investigational medicinal agent
6. Is participating, or who is due to participate at any time during the study, in a therapeutic clinical trial. For any other trials (e.g. observational or using approved medication), consultation with Pulmocide and the medical monitor is required.
7. Has an endobronchial stent in situ
8. Known history of allergy, hypersensitivity, or any previous serious reaction to any component of the opelconazole formulation, azoles, echinocandins, or amphotericin B
9. Elevated alanine transaminase (ALT) or, aspartate transaminase (AST) > 5 x the upper limit of normal (ULN)
10. Any known history or current evidence of alcohol or drug abuse that, in the Investigator's opinion, would exclude the participant from participation in the study

12. Life expectancy is not expected to be sustained for the duration of the trial (16 weeks), in the opinion of the investigator

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Opelconazole; Opelconazole administered for 12 weeks	Drug: Opelconazole; Nebulizer suspension; Other Names: PC945
Active Comparator: Standard of Care (SoC); Mold-active SoC	Drug: Standard of Care; Standard of Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Participants Who Completed 12 Weeks of Therapy	Percentage of Participants Who Completed 12 Weeks of PC945 or Initial Standard of Care (SoC)	Week 12

Collaborators and Investigators

• Sponsor: Pulmocide Ltd
• Investigators: Study Director: Vice President Clinical Development, Pulmocide Ltd

Study record dates

Study Major Dates

• Study Start (Actual): November 19, 2021
• Primary Completion (Actual): October 19, 2023
• Study Completion (Actual): November 13, 2023

Study Registration Dates

• First Submitted: August 31, 2021
• First Submitted That Met QC Criteria: August 31, 2021
• First Posted (Actual): September 8, 2021

Study Record Updates

• Last Update Posted (Actual): April 30, 2026
• Last Update Submitted That Met QC Criteria: April 10, 2026
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Diseases; Lung Diseases; Bacterial Infections and Mycoses; Lung Diseases, Fungal; Mycoses; Aspergillosis; Pulmonary Aspergillosis; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: PC_ASP_007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No