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

NCT05037851 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: PC_ASP_007
• Study Type: interventional
• Target: 102
• Locations: 2 countries
• Sites: 19

Brief Summary

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.

Conditions

Pulmonary Aspergillosis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Opelconazole

EXPERIMENTAL

Opelconazole administered for 12 weeks

Drug: Opelconazole

Standard of Care (SoC)

ACTIVE COMPARATOR

Mold-active SoC

Drug: Standard of Care

Interventions

Opelconazole DRUG

Nebulizer suspension

Also known as: PC945

Opelconazole

Standard of Care DRUG

Standard of Care

Standard of Care (SoC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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
• a. (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
• b. (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

You may not qualify if:

• Participant would normally receive nebulized amphotericin B as the only mold active antifungal agent as initial SoC prophylaxis or pre-emptive therapy
• Fungal disease requiring systemic antifungal treatment at the time of transplant
• 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)
• Has previously received opelconazole
• Is receiving, or who is due to receive at any time during the study, an investigational medicinal agent
• 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.
• Has an endobronchial stent in situ
• Known history of allergy, hypersensitivity, or any previous serious reaction to any component of the opelconazole formulation, azoles, echinocandins, or amphotericin B
• Elevated alanine transaminase (ALT) or, aspartate transaminase (AST) \> 5 x the upper limit of normal (ULN)
• 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
• \. Life expectancy is not expected to be sustained for the duration of the trial (16 weeks), in the opinion of the investigator

Sponsors & Collaborators

• Pulmocide Ltd: lead

Study Sites (19)

Clinical Research Site

Phoenix, Arizona, 85013, United States

Location

Clinical Research Site

La Jolla, California, 92037, United States

Location

Clinical Research Site

Los Angeles, California, 90095, United States

Location

Clinical Research Site

Jacksonville, Florida, 32224, United States

Location

Clinical Research Site

Tampa, Florida, 33606, United States

Location

Clinical Research Site

Maywood, Illinois, 60153, United States

Location

Research Site

St Louis, Missouri, 63110, United States

Location

Clinical Research Site

New York, New York, 10016, United States

Location

Clinical Research Site

The Bronx, New York, 10467, United States

Location

Clinical Research Site

Philadelphia, Pennsylvania, 19104, United States

Location

Clinical Research Site

Philadelphia, Pennsylvania, 19140, United States

Location

Clinical Research Site

Pittsburgh, Pennsylvania, 15213, United States

Location

Clinical Research Site

Nashville, Tennessee, 37232, United States

Location

Clinical Research Site

Dallas, Texas, 75246, United States

Location

Clinical Research Site 1

Houston, Texas, 77030, United States

Location

Clinical Research Site 2

Houston, Texas, 77030, United States

Location

Clinical Research Site 3

Houston, Texas, 77030, United States

Location

Clinical Research Site

Edmonton, T6G 1Z1, Canada

Location

Clinical Research Site

Toronto, M5G 2N2, Canada

Location

MeSH Terms

Conditions

Pulmonary Aspergillosis

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Aspergillosis; Mycoses; Bacterial Infections and Mycoses; Infections; Lung Diseases, Fungal; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Pulmocide Administrators
• Organization: Pulmocide

admin@pulmocide.com

+44 (0)203 763 9484

Study Officials

• Vice President Clinical Development

  Pulmocide Ltd

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The study will be an open-label study. For the purposes of the exploratory efficacy assessments, however, the Data Review Committee determining the presence of pulmonary fungal disease will be blinded as to treatment assignment. The Sponsor will limit knowledge of treatment assignment to as few sponsor personnel as possible to reduce bias.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open-label, randomized, active-controlled, parallel-group multi-center study

Study Record Dates

• First Submitted: August 31, 2021
• First Posted: September 8, 2021
• Study Start: November 19, 2021
• Primary Completion: October 19, 2023
• Study Completion: November 13, 2023
• Last Updated: April 30, 2026
• Results First Posted: April 30, 2026

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2); US (17)