Refractory IPAPhase 3NCT05238116

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

A Phase 3 study testing PC945 in people with Refractory IPA, run by Pulmocide Ltd at 83 sites in 20 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

To assess the safety and efficacy of nebulized PC945 in combination with systemic antifungal therapy for the treatment of refractory IPA Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Refractory IPA
What is being tested?: PC945
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 85 participants
Where: 83 sitesin 20 countries
Study dates: 14 Jun 2022to 29 Dec 2025
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.
Participant's IPA has failed to respond to adequate antifungal therapy.

Who cannot join

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 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

Trial locations and contacts

83 sites in 20 countries.

Country

City, postcode or hospital

83 sites in 20 countries

United States15 sites

Clinical Research Site
Ann Arbor, Michigan, 48109
Clinical Research Site
Baltimore, Maryland, 21287
Clinical Research Site 1
Houston, Texas, 77030
Clinical Research Site 2
Houston, Texas, 77030
Clinical Research Site
Jacksonville, Florida, 32224
Clinical Research Site
La Jolla, California, 92037
Clinical Research Site
Los Angeles, California, 90048
Clinical R Site
Los Angeles, California, 90095
Clinical Research Site
Madison, Wisconsin, 53792
Clinical Research Site
Minneapolis, Minnesota, 55455
Clinical Research Site
Philadelphia, Pennsylvania, 19014
Clinical Research Site
Pittsburgh, Pennsylvania, 15213
Clinical Research Site
Sacramento, California, 95817
Clinical Research Site
St Louis, Missouri, 63110
Clinical Research Site
The Bronx, New York, 10467

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Brazil7 sites

Clinical Research Site
Curitiba, Paraná, 80060-900
Clinical Research Site
Curitiba, Paraná, 81520060
Clinical Research Site
Jaú, São Paulo, 17210-080
Clinical Research Site
Passo Fundo, Rio Grande do Sul, 99010260
Clinical Research Site
Porto Alegre, Rio Grande do Sul, 90035903
Clinical Research Site
Santa Maria, Rio Grande do Sul, 97105900
Clinical Research Site
Santos, São Paulo, 11075101

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South Korea6 sites

Clinical Research Site
Daejeon, 35015
Clinical Research Site
Incheon, 21565
Clinical Research Site
Seoul, 02841
Clinical Research Site
Seoul, 06273
Clinical Research Site
Seoul, 06351
Clinical Research Site
Seoul, 06591

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Spain6 sites

Clinical Research Site
Barcelona, Catalonia, 08035
Clinical Research Site
Barcelona, Catalonia, 08036
Clinical Research Site
Córdoba, Andalusia, 14004
Clinical Research Site
Granada, 18014
Clinical Research Site
Majadahonda, Madrid, 28222
Clinical Research Site
Valencia, 46026

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Argentina5 sites

Clinical Research Site
Caba, Buenos Aires, C1199ABB
Clinical Research Site
Caba, Buenos Aries, C1118AAT
Clinical Research Site
La Plata, Buenos Aires, B1900
Clinical Research Site
Mendoza, M5500
Clinical Research Site
Rosario, Santa Fe Province, S2000CVB

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India5 sites

Clinical Research Site
Bengaluru, Karnataka, 560034
Clinical Research Site
Hyderabad, Telangana, 500082
Clinical Research Site
New Delhi, 110017
Clinical Research Site 1
Pune, Maharashtra, 411004
Clinical Research Site 2
Pune, Maharashtra, 411004

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Italy5 sites

Clinical Research Site
Brescia, Lombardy, 25123
Clinical Research Site
Monza, 20900
Clinical Research Site
Naples, 80131
Clinical Research Site
Rome, 00168
Clinical Research Site
Siena, 53100

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United Kingdom5 sites

Clinical Research Site
Harefield, Middlesex, UB9 6JH
Clinical Research Site
London, SE5 9RS
Clinical Research Site
London, SW17 0QT
Clinical Research Site
London, W12 0HS
Clinical Research Site
Manchester, M23 9LT

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Taiwan4 sites

Clinical Research Site
Kaohsiung City, 807377
Clinical Research Site
New Taipei City, 220
Clinical Research Site
New Taipei City, 23561
Clinical Research Site
Tapei City, Tapai, 100225

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Thailand4 sites

Clinical Research Site
Bangkok, 10400
Clinical Research Site
Bangkok, 10700
Clinical Research Site
Khlong Luang, Changwat Pathum Thani, 12120
Clinical Research Site
Khon Kaen, 40002

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Belgium3 sites

Clinical Research Site
Brussels, B-1070
Clinical Research Site
Brussels, B-1200
Clinical Research Site
Leuven, B-3000

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Canada3 sites

Clinical Research Site
Hamilton, Ontario, L8V 1C3
Clinical Research Site
Toronto, Ontario, M5G 2C4
Clinical Research Site
Toronto, Ontario, M6G2N2

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Australia2 sites

Clinical Research Site
Melbourne, Victoria, 3004
Clinical Research Site
Parkville, Victoria, 3050

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Austria2 sites

Clinical Research Site
Graz, Styria, 8036
Clinical Research Site
Vienna, 1090

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Colombia2 sites

Clinical Research Site
Cali, Valle del Cauca Department, 760032
Clinical Research Site
Montería, Departamento de Córdoba, 230002

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France2 sites

Clinical Research Site
Paris, 75015
Clinical Research Site
Strasbourg, 67091

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Germany2 sites

Clinical Research Site
Frankfurt am Main, Hesse, 60590
Clinical Research Site
Würzburg, Bavaria, 97080

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Greece2 sites

Clinical Research Site
Athens, 11527
Clinical Research Site
Thessaloniki, 57010

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Israel2 sites

Clinical Research Site
Haifa, 3109601
Clinical Research Site
Ramat Gan, 5266202

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Chile1 site

Clinical Research Site
Valparaíso, 2570017

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About this study

Official title: 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

Conditions: Refractory IPA
Being tested: PC945, Placebo
Keywords: Refractory IPA, invasive pulmonary aspergillosis
Medical subject headings: Invasive Pulmonary Aspergillosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PC945Drug
Sterile aqueous liquid for Nebulization
PlaceboDrug
Sterile aqueous liquid for Nebulization

Study groups in NCT05238116
Study group	Role	What they receive
PC945	Experimental	PC945 dose, administered via nebulizer, twice daily Receives: Drug: PC945
Placebo	Placebo comparator	PC945-placebo administered via nebulizer, twice daily Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants Alive With Favorable Overall Response as Assessed by the Data Review Committee (DRC)
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.
Measured: At Day 84

Secondary outcomes (3)

Number of Participants With Favorable Overall Response
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.
Measured: up to 12 weeks (Day 84)
Time to Favorable Overall Response
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.
Measured: up to Day 42 or Day 84
All-cause Mortality
All-cause mortality was defined as death from any cause.
Measured: From First Dose of Study Treatment up to Week 16 (Safety Follow-up)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Jun 202229 Dec 2025

First posted14 Feb 2022
Study start14 Jun 2022
Primary completion29 Dec 2025
Study completion29 Dec 2025

Why it stopped: The study was terminated by the Sponsor based on a sample size recalculation interim analysis which showed a numerically lower favorable response rate and a numerically higher mortality rate in the opelconazole arm compared to the control arm.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Refractory IPAStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 85 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05238116
Sponsor's protocol ID: PC_ASP_006
Other IDs: 2021-004554-32, 2024-511281-36
Status last verified: Jan 2026
First submitted: 3 Feb 2022
Last updated: 30 Apr 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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)
ClinicalTrials.gov ID: NCT05238116
Acronym / sponsor ID: PC_ASP_006
Conditions: Refractory IPA
Keywords: Refractory IPA, invasive pulmonary aspergillosis
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: The study was terminated by the Sponsor based on a sample size recalculation interim analysis which showed a numerically lower favorable response rate and a numerically higher mortality rate in the opelconazole arm compared to the control arm.
Enrolment: 85 participants (actual)
Lead sponsor: Pulmocide LtdIndustry (pharma, biotech, devices)
Study start: 14 Jun 2022 (actual)
Primary completion: 29 Dec 2025 (actual)
Study completion: 29 Dec 2025 (actual)
First posted: 14 Feb 2022 (actual)
Results: Posted 30 Apr 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
PC945	Experimental	Drug: PC945PC945 dose, administered via nebulizer, twice daily
Placebo	Placebo comparator	Drug: PlaceboPC945-placebo administered via nebulizer, twice daily

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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.
Participant's IPA has failed to respond to adequate antifungal therapy.

Key exclusion criteria (4 listed)

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 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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PC945Sterile aqueous liquid for Nebulization	Drug	PC945
PlaceboSterile aqueous liquid for Nebulization	Drug	Placebo

Primary outcome

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.

3 secondary outcomes

Number of Participants With Favorable Overall Response
Time frame: up to 12 weeks (Day 84)
Time to Favorable Overall Response
Time frame: 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)

Results and safety

Results posted to the registry on 30 Apr 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
PC945	57	23
Placebo	28	15

Primary outcome: Number of Participants Alive With Favorable Overall Response as Assessed by the Data Review Committee (DRC)

Time frame: At Day 84. Number. Unit: participants

Measure	PC945 n = 41	Placebo n = 20
High Risk Participants	9	5
Low Risk Participants	2	3
Overall	11	8

Population analysed: For the interim analysis, the modified intention-to-treat (mITT) population was defined as randomized participants who had DRC-confirmed refractory, proven or probable invasive pulmonary aspergillosis (IPA), and who received at least one dose of blinded study drug. Overall number of participants analyzed = participants evaluable for this outcome measure. Randomization was stratified by mortality risk (high vs low).

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: From First Dose of Study up to Week 16 (Safety Follow-up). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
PC945	36 of 56 (64.3%)	45 of 56 (80.4%)	21 of 57
Placebo	18 of 27 (66.7%)	25 of 27 (92.6%)	8 of 28

Limitations and caveats (from the sponsor): This Phase 3 study was terminated early based on the results of the sample size recalculation interim analysis.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

83 sites in 20 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing PC945 in people with Refractory IPA, run by Pulmocide Ltd at 83 sites in 20 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 83 sites in United States, Brazil, South Korea, Spain, Argentina and 15 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Alive With Favorable Overall Response as Assessed by the Data Review Committee (DRC) (time frame: At Day 84). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05238116.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.