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

April 10, 2026 updated by: Pulmocide Ltd

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)

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

85

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Mendoza, Argentina, M5500
        • Clinical Research Site
    • Buenos Aires
      • Caba, Buenos Aires, Argentina, C1199ABB
        • Clinical Research Site
      • La Plata, Buenos Aires, Argentina, B1900
        • Clinical Research Site
    • Buenos Aries
      • Caba, Buenos Aries, Argentina, C1118AAT
        • Clinical Research Site
    • Santa Fe Province
      • Rosario, Santa Fe Province, Argentina, S2000CVB
        • Clinical Research Site
  • Australia
    • Victoria
      • Melbourne, Victoria, Australia, 3004
        • Clinical Research Site
      • Parkville, Victoria, Australia, 3050
        • Clinical Research Site
  • Austria
      • Vienna, Austria, 1090
        • Clinical Research Site
    • Styria
      • Graz, Styria, Austria, 8036
        • Clinical Research Site
  • Belgium
      • Brussels, Belgium, B-1070
        • Clinical Research Site
      • Brussels, Belgium, B-1200
        • Clinical Research Site
      • Leuven, Belgium, B-3000
        • Clinical Research Site
  • Brazil
    • Paraná
      • Curitiba, Paraná, Brazil, 80060-900
        • Clinical Research Site
      • Curitiba, Paraná, Brazil, 81520060
        • Clinical Research Site
    • Rio Grande do Sul
      • Passo Fundo, Rio Grande do Sul, Brazil, 99010260
        • Clinical Research Site
      • Porto Alegre, Rio Grande do Sul, Brazil, 90035903
        • Clinical Research Site
      • Santa Maria, Rio Grande do Sul, Brazil, 97105900
        • Clinical Research Site
    • São Paulo
      • Jaú, São Paulo, Brazil, 17210-080
        • Clinical Research Site
      • Santos, São Paulo, Brazil, 11075101
        • Clinical Research Site
  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8V 1C3
        • Clinical Research Site
      • Toronto, Ontario, Canada, M5G 2C4
        • Clinical Research Site
      • Toronto, Ontario, Canada, M6G2N2
        • Clinical Research Site
  • Chile
      • Valparaíso, Chile, 2570017
        • Clinical Research Site
  • Colombia
    • Departamento de Córdoba
      • Montería, Departamento de Córdoba, Colombia, 230002
        • Clinical Research Site
    • Valle del Cauca Department
      • Cali, Valle del Cauca Department, Colombia, 760032
        • Clinical Research Site
  • France
      • Paris, France, 75015
        • Clinical Research Site
      • Strasbourg, France, 67091
        • Clinical Research Site
  • Germany
    • Bavaria
      • Würzburg, Bavaria, Germany, 97080
        • Clinical Research Site
    • Hesse
      • Frankfurt am Main, Hesse, Germany, 60590
        • Clinical Research Site
  • Greece
      • Athens, Greece, 11527
        • Clinical Research Site
      • Thessaloniki, Greece, 57010
        • Clinical Research Site
  • India
      • New Delhi, India, 110017
        • Clinical Research Site
    • Karnataka
      • Bengaluru, Karnataka, India, 560034
        • Clinical Research Site
    • Maharashtra
      • Pune, Maharashtra, India, 411004
        • Clinical Research Site 1
      • Pune, Maharashtra, India, 411004
        • Clinical Research Site 2
    • Telangana
      • Hyderabad, Telangana, India, 500082
        • Clinical Research Site
  • Israel
      • Haifa, Israel, 3109601
        • Clinical Research Site
      • Ramat Gan, Israel, 5266202
        • Clinical Research Site
  • Italy
      • Monza, Italy, 20900
        • Clinical Research Site
      • Naples, Italy, 80131
        • Clinical Research Site
      • Rome, Italy, 00168
        • Clinical Research Site
      • Siena, Italy, 53100
        • Clinical Research Site
    • Lombardy
      • Brescia, Lombardy, Italy, 25123
        • Clinical Research Site
  • South Korea
      • Daejeon, South Korea, 35015
        • Clinical Research Site
      • Incheon, South Korea, 21565
        • Clinical Research Site
      • Seoul, South Korea, 02841
        • Clinical Research Site
      • Seoul, South Korea, 06273
        • Clinical Research Site
      • Seoul, South Korea, 06351
        • Clinical Research Site
      • Seoul, South Korea, 06591
        • Clinical Research Site
  • Spain
      • Granada, Spain, 18014
        • Clinical Research Site
      • Valencia, Spain, 46026
        • Clinical Research Site
    • Andalusia
      • Córdoba, Andalusia, Spain, 14004
        • Clinical Research Site
    • Catalonia
      • Barcelona, Catalonia, Spain, 08035
        • Clinical Research Site
      • Barcelona, Catalonia, Spain, 08036
        • Clinical Research Site
    • Madrid
      • Majadahonda, Madrid, Spain, 28222
        • Clinical Research Site
  • Taiwan
      • Kaohsiung City, Taiwan, 807377
        • Clinical Research Site
      • New Taipei City, Taiwan, 220
        • Clinical Research Site
      • New Taipei City, Taiwan, 23561
        • Clinical Research Site
    • Tapai
      • Tapei City, Tapai, Taiwan, 100225
        • Clinical Research Site
  • Thailand
      • Bangkok, Thailand, 10400
        • Clinical Research Site
      • Bangkok, Thailand, 10700
        • Clinical Research Site
      • Khon Kaen, Thailand, 40002
        • Clinical Research Site
    • Changwat Pathum Thani
      • Khlong Luang, Changwat Pathum Thani, Thailand, 12120
        • Clinical Research Site
  • United Kingdom
      • London, United Kingdom, SE5 9RS
        • Clinical Research Site
      • London, United Kingdom, SW17 0QT
        • Clinical Research Site
      • London, United Kingdom, W12 0HS
        • Clinical Research Site
      • Manchester, United Kingdom, M23 9LT
        • Clinical Research Site
    • Middlesex
      • Harefield, Middlesex, United Kingdom, UB9 6JH
        • Clinical Research Site
  • United States
    • California
      • La Jolla, California, United States, 92037
        • Clinical Research Site
      • Los Angeles, California, United States, 90048
        • Clinical Research Site
      • Los Angeles, California, United States, 90095
        • Clinical R Site
      • Sacramento, California, United States, 95817
        • Clinical Research Site
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Clinical Research Site
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Clinical Research Site
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Clinical Research Site
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Clinical Research Site
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Clinical Research Site
    • New York
      • The Bronx, New York, United States, 10467
        • Clinical Research Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19014
        • Clinical Research Site
      • Pittsburgh, Pennsylvania, United States, 15213
        • Clinical Research Site
    • Texas
      • Houston, Texas, United States, 77030
        • Clinical Research Site 1
      • Houston, Texas, United States, 77030
        • Clinical Research Site 2
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • Clinical Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Alive With Favorable Overall Response as Assessed by the Data Review Committee (DRC)
Time Frame: At Day 84
Favorable overall response was defined as being alive and having a complete or partial overall response at Day 84 as determined by the DRC. Complete or partial response was defined by the Classification and Criteria for the Assessment of Overall Response, adapted from Segal, 2008.
At Day 84

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Favorable Overall Response
Time Frame: up to 12 weeks (Day 84)
Favorable overall response was defined as having a complete or partial overall response at at any time during the 12-week treatment where the survival component was not included as a part of the response definition. Complete or partial response was defined by the Classification and Criteria for the Assessment of Overall Response, adapted from Segal, 2008.
up to 12 weeks (Day 84)
Time to Favorable Overall Response
Time Frame: up to Day 42 or Day 84
Time to favorable overall response was defined as the time from randomization to the first favorable overall response (complete or partial response). Complete or partial response was defined by the Classification and Criteria for the Assessment of Overall Response, adapted from Segal, 2008.
up to Day 42 or Day 84
All-cause Mortality
Time Frame: From First Dose of Study Treatment up to Week 16 (Safety Follow-up)
All-cause mortality was defined as death from any cause.
From First Dose of Study Treatment up to Week 16 (Safety Follow-up)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pulmocide Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 14, 2022

Primary Completion (Actual)

December 29, 2025

Study Completion (Actual)

December 29, 2025

Study Registration Dates

First Submitted

February 3, 2022

First Submitted That Met QC Criteria

February 11, 2022

First Posted (Actual)

February 14, 2022

Study Record Updates

Last Update Posted (Actual)

April 30, 2026

Last Update Submitted That Met QC Criteria

April 10, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PC_ASP_006
  • 2021-004554-32 (EudraCT Number)
  • 2024-511281-36 (Registry Identifier: EU CT Number)

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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