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

NCT05238116 | Terminated Phase 3 Results DMC FDA Drug

• 3 other identifiers: PC_ASP_0062021-004554-322024-511281-36
• Study Type: interventional
• Target: 85
• Locations: 19 countries
• Sites: 81

Brief Summary

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

Conditions

Refractory IPA

Keywords

Refractory IPA; invasive pulmonary aspergillosis

Outcome Measures

Primary Outcomes (1)

• 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.

  At Day 84

Secondary Outcomes (3)

• Number of Participants With Favorable Overall Response

  up to 12 weeks (Day 84)

• Time to Favorable Overall Response

  up to Day 42 or Day 84

• All-cause Mortality

  From First Dose of Study Treatment up to Week 16 (Safety Follow-up)

Study Arms (2)

PC945

EXPERIMENTAL

PC945 dose, administered via nebulizer, twice daily

Drug: PC945

Placebo

PLACEBO COMPARATOR

PC945-placebo administered via nebulizer, twice daily

Drug: Placebo

Interventions

PC945 DRUG

Sterile aqueous liquid for Nebulization

PC945

Placebo DRUG

Sterile aqueous liquid for Nebulization

Placebo

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Pulmocide Ltd: lead

Study Sites (83)

Clinical Research Site

La Jolla, California, 92037, United States

Location

Clinical Research Site

Los Angeles, California, 90048, United States

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Clinical R Site

Los Angeles, California, 90095, United States

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Sacramento, California, 95817, United States

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Jacksonville, Florida, 32224, United States

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Baltimore, Maryland, 21287, United States

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Ann Arbor, Michigan, 48109, United States

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Minneapolis, Minnesota, 55455, United States

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St Louis, Missouri, 63110, United States

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The Bronx, New York, 10467, United States

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Philadelphia, Pennsylvania, 19014, United States

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Pittsburgh, Pennsylvania, 15213, United States

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Clinical Research Site 1

Houston, Texas, 77030, United States

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Clinical Research Site 2

Houston, Texas, 77030, United States

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Madison, Wisconsin, 53792, United States

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Clinical Research Site

Caba, Buenos Aires, C1199ABB, Argentina

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Clinical Research Site

La Plata, Buenos Aires, B1900, Argentina

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Clinical Research Site

Caba, Buenos Aries, C1118AAT, Argentina

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Rosario, Santa Fe Province, S2000CVB, Argentina

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Mendoza, M5500, Argentina

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Melbourne, Victoria, 3004, Australia

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Parkville, Victoria, 3050, Australia

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Graz, Styria, 8036, Austria

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Vienna, 1090, Austria

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Brussels, B-1070, Belgium

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Brussels, B-1200, Belgium

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Leuven, B-3000, Belgium

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Curitiba, Paraná, 80060-900, Brazil

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Curitiba, Paraná, 81520060, Brazil

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Passo Fundo, Rio Grande do Sul, 99010260, Brazil

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Porto Alegre, Rio Grande do Sul, 90035903, Brazil

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Santa Maria, Rio Grande do Sul, 97105900, Brazil

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Jaú, São Paulo, 17210-080, Brazil

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Santos, São Paulo, 11075101, Brazil

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Hamilton, Ontario, L8V 1C3, Canada

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Toronto, Ontario, M5G 2C4, Canada

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Toronto, Ontario, M6G2N2, Canada

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Valparaíso, 2570017, Chile

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Montería, Departamento de Córdoba, 230002, Colombia

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Cali, Valle del Cauca Department, 760032, Colombia

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Paris, 75015, France

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Strasbourg, 67091, France

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Würzburg, Bavaria, 97080, Germany

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Clinical Research Site

Frankfurt am Main, Hesse, 60590, Germany

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Athens, 11527, Greece

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Clinical Research Site

Thessaloniki, 57010, Greece

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Clinical Research Site

Bengaluru, Karnataka, 560034, India

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Clinical Research Site 1

Pune, Maharashtra, 411004, India

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Clinical Research Site 2

Pune, Maharashtra, 411004, India

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Hyderabad, Telangana, 500082, India

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New Delhi, 110017, India

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Haifa, 3109601, Israel

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Ramat Gan, 5266202, Israel

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Brescia, Lombardy, 25123, Italy

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Monza, 20900, Italy

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Naples, 80131, Italy

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Clinical Research Site

Rome, 00168, Italy

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Clinical Research Site

Siena, 53100, Italy

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Clinical Research Site

Daejeon, 35015, South Korea

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Clinical Research Site

Incheon, 21565, South Korea

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Clinical Research Site

Seoul, 02841, South Korea

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Clinical Research Site

Seoul, 06273, South Korea

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Clinical Research Site

Seoul, 06351, South Korea

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Clinical Research Site

Seoul, 06591, South Korea

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Clinical Research Site

Córdoba, Andalusia, 14004, Spain

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Clinical Research Site

Barcelona, Catalonia, 08035, Spain

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Clinical Research Site

Barcelona, Catalonia, 08036, Spain

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Clinical Research Site

Majadahonda, Madrid, 28222, Spain

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Clinical Research Site

Granada, 18014, Spain

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Clinical Research Site

Valencia, 46026, Spain

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Clinical Research Site

Tapei City, Tapai, 100225, Taiwan

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Clinical Research Site

Kaohsiung City, 807377, Taiwan

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Clinical Research Site

New Taipei City, 220, Taiwan

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Clinical Research Site

New Taipei City, 23561, Taiwan

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Clinical Research Site

Khlong Luang, Changwat Pathum Thani, 12120, Thailand

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Clinical Research Site

Bangkok, 10400, Thailand

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Clinical Research Site

Bangkok, 10700, Thailand

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Clinical Research Site

Khon Kaen, 40002, Thailand

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Clinical Research Site

Harefield, Middlesex, UB9 6JH, United Kingdom

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Clinical Research Site

London, SE5 9RS, United Kingdom

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Clinical Research Site

London, SW17 0QT, United Kingdom

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Clinical Research Site

London, W12 0HS, United Kingdom

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Clinical Research Site

Manchester, M23 9LT, United Kingdom

Location

MeSH Terms

Conditions

Invasive Pulmonary Aspergillosis

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

This Phase 3 study was terminated early based on the results of the sample size recalculation interim analysis.

Results Point of Contact

• Title: Pulmocide Administrators
• Organization: Pulmocide

admin@pulmocide.com

+44 (0)203 763 9484

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double Blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2022
• First Posted: February 14, 2022
• Study Start: June 14, 2022
• Primary Completion: December 29, 2025
• Study Completion: December 29, 2025
• Last Updated: April 30, 2026
• Results First Posted: April 30, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (5); CA (3); GR (2); FR (2); AR (5); ES (6); TW (4); AU (2); CO (2); GB (5); IN (5); TH (4); IL (2); KR (6); DE (2); BE (3); US (15); CL (1); BR (7)