Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ended
Participants planned
123
Countries
7
Sites
24
Refractory Invasive Pulmonary Aspergillosis
To assess the efficacy of nebulized PC945 in combination with systemic antifungal therapy for the treatment of refractory IPA
Key facts
- Sponsor
- Pulmocide Limited
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Bacterial Infections and Mycoses [C01]
- Trial duration
- 17 Nov 2022 → 30 Dec 2025
- Decision date (initial)
- 2024-12-11
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
- Funding sources
- Pulmocide Ltd United Kingdom
External identifiers
- EU CT number
- 2024-511281-36-00
- EudraCT number
- 2021-004554-32
- WHO UTN
- U1111-1304-0792
- ClinicalTrials.gov
- NCT05238116
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Pharmacokinetic, Therapy, Safety
To assess the efficacy of nebulized PC945 in combination with systemic antifungal therapy for the treatment of refractory IPA
Secondary objectives 1
- To assess the safety and tolerability of nebulized PC945 in combination with systemic antifungal therapy for the treatment of refractory IPA.
Conditions and MedDRA coding
Refractory Invasive Pulmonary Aspergillosis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10059259 | Pulmonary aspergillosis | 10021881 |
Regulatory references
- Scientific advice from competent authorities
- Health Products Regulatory Authority
- Plan to share IPD
- No
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 2
- 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 4
- 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
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Number of Participants with Complete or Partial Overall Response up to 12 Weeks (Day 84)
Secondary endpoints 1
- Time to Complete or Partial Overall Clinical Response up to 12 Weeks (Day 84)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD5722421 · Product
- Active substance
- Opelconazole
- Pharmaceutical form
- NEBULISER SUSPENSION
- Route of administration
- INHALATION USE
- Max daily dose
- 29.6 mg/g milligram(s)/gram
- Max total dose
- 2486.40 mg/g milligram(s)/gram
- Max treatment duration
- 84 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- PULMOCIDE LTD
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/22/2745
Placebo 1
PC945 Placebo Nebuliser Liquid
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Pulmocide Limited
- Sponsor organisation
- Pulmocide Limited
- Address
- 44 Southampton Buildings
- City
- London
- Postcode
- WC2A 1AP
- Country
- United Kingdom
Scientific contact point
- Organisation
- Pulmocide Limited
- Contact name
- Sonya Roeloffzen
Public contact point
- Organisation
- Pulmocide Limited
- Contact name
- Pulmocide Admin
Third parties 13
| Organisation | City, country | Duties |
|---|---|---|
| Cerba Research ORG-100042694
|
Gent, Belgium | Laboratory analysis |
| Propharma Group LLC ORG-100048652
|
Raleigh, United States | Code 8 |
| Jones Microbiology Institute Inc. ORG-100043091
|
North Liberty, United States | Laboratory analysis |
| Drug Development Solutions Limited ORG-100045894
|
Ely, United Kingdom | Laboratory analysis |
| Psi CRO GmbH ORG-100030010
|
Vienna, Austria | On site monitoring, Code 10, Code 11, Code 12, Code 13, Other, Code 2, Code 5, Data management |
| Respiratory Molecular Pharmacology (RMP) Group ORL-000010603
|
London, United Kingdom | Laboratory analysis |
| University Hospital Of Wales ORG-100030992
|
Cardiff, United Kingdom | Laboratory analysis |
| Bioclinica Inc. ORG-100033079
|
Princeton, United States | Other |
| Medidata Solutions International Limited ORG-100048319
|
London, United Kingdom | E-data capture |
| Cerba ORG-100042812
|
Frepillon, France | Laboratory analysis |
| University Health Network ORG-100010555
|
Toronto, Canada | Laboratory analysis |
| Psi CRO Greece ORG-100047165
|
Athens, Greece | On site monitoring, Code 12, Code 2 |
| 4g Clinical LLC ORG-100042775
|
Wellesley, United States | Interactive response technologies (IRT) |
Locations
7 EU/EEA countries · 24 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ended | 6 | 2 |
| Belgium | Ended | 4 | 3 |
| France | Ended | 4 | 2 |
| Germany | Ended | 7 | 3 |
| Greece | Ended | 4 | 2 |
| Italy | Ended | 10 | 5 |
| Spain | Ended | 11 | 7 |
| Rest of world
Taiwan, United Kingdom, United States, Korea, Republic of, Argentina, Thailand, Australia, Canada, Brazil, Israel, Chile, India, Colombia
|
— | 77 | — |
Investigational sites
Medical University Of Graz
Department of Internal Medicine, Clinical Department of Infectious Diseases and Tropical Medicine, Neue Stiftingtalstrasse 6, 8010, Graz
Medical University Of Vienna
Department of Thoracic Surgery, Waehringer Guertel 18-20, Alsergrund, Vienna
UZ Leuven
Hematology, Herestraat 49, 3000, Leuven
Hopital Erasme
Infectious Diseases, Lennikse Baan 808, 1070, Anderlecht
Cliniques Universitaires Saint-Luc
Infectious Diseases, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe
Les Hopitaux Universitaires De Strasbourg
Department of Tropical Diseases, Civil Hospital, 1 Place De L Hopital, Cs 80426, Strasbourg Cedex
Hopital Necker Enfants Malades
Department of Infectious Diseases, 149 Rue De Sevres, 75015, Paris
Universitaetsklinikum Frankfurt AöR
Central Inner Medicine II, Theodor-Stern-Kai 7, 60590, Frankfurt Am Main
Universitaetsklinikum Wuerzburg AöR
Medical Clinic and Polyclinic II, Oberduerrbacher Strasse 6, Grombuehl, Wuerzburg
University Hospital Cologne AöR
Department for Internal Medicine I, Kerpener Strasse 62, Lindenthal, Cologne
Geniko Nosokomeio Thessalonikis George Papanikolaou
Hematology Department, Exochi, 570 10, Thessaloniki
Laiko General Hospital Of Athens
1st Department of Internal Medicine, Agiou Thoma (goudi) 17, 115 27, Athens
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Department of Infectious Diseases, Piazzale Spedali Civili 1, 25123, Brescia
Azienda Ospedaliera Universitaria Federico II Di Napoli
Department of Infectious Diseases, Via Sergio Pansini 5, 80131, Naples
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department of Infectious Diseases, Largo Francesco Vito 1, 00168, Rome
Fondazione IRCCS San Gerardo Dei Tintori
Department of Infectious Diseases, Via Giovanni Battista Pergolesi 33, 20900, Monza
Azienda Ospedaliera Universitaria Senese
Department of Infectious Diseases, Strada Delle Scotte 14, 53100, Siena
Hospital Universitario Virgen De Las Nieves
Department of Infectious Diseases, Avenida De Las Fuerzas Armadas 2, 18014, Granada
Hospital Universitario Y Politecnico La Fe
Pneumology, Avenida Fernando Abril Martorell 106, 46026, Valencia
Hospital Universitario Reina Sofia
Department of Infectious Diseases, Avenida Menendez Pidal S/n, 14004, Cordoba
Hospital Universitario Puerta De Hierro De Majadahonda
Department of Infectious Diseases, Calle De Joaquin Rodrigo 2, 28222, Majadahonda
Hospital Universitario Marques De Valdecilla
Pneumology, Avenida Valdecilla Sn, 39008, Santander
Hospital Clinic De Barcelona
Department of Infectious Diseases, Calle Villarroel 170, 08036, Barcelona
Hospital Universitari Vall D Hebron
Department of Infectious Diseases, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Austria | 2023-02-08 | 2023-02-15 | 2025-12-19 | ||
| Belgium | 2023-04-26 | 2023-04-29 | 2025-12-19 | ||
| France | 2023-02-08 | 2025-01-15 | 2025-12-19 | ||
| Germany | 2023-07-19 | 2024-03-14 | 2025-12-19 | ||
| Greece | 2023-03-17 | 2023-03-31 | 2025-12-19 | ||
| Italy | 2023-04-07 | 2023-09-26 | 2025-12-19 | ||
| Spain | 2022-11-17 | 2023-05-11 | 2025-12-19 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Serious breaches 1 · Art. 52 CTR
Serious breach SB-94198
- Sponsor became aware
- 2025-08-05
- Date of breach
- 2025-06-04
- Submission date
- 2025-10-14
- Member states concerned
- Austria, Belgium, France, Germany, Greece, Italy, Spain
- Categories
- Regulation, Protocol
- Areas impacted
- Subject rights
- Benefit-risk balance changed
- No
- Description
- Please refer to the supporting documentation as uploaded in CTIS
- Sponsor actions
- Please refer to the supporting documentation as uploaded in CTIS
| Organisation | City | Country | Type |
|---|---|---|---|
| Medical University Of Vienna | Vienna | Austria | Clinical investigator |
| Hospital Universitario Virgen De Las Nieves | Granada | Spain | Clinical investigator |
| Hospital Universitari Vall D Hebron | Barcelona | Spain | Clinical investigator |
| Universitaetsklinikum Frankfurt AöR | Frankfurt Am Main | Germany | Clinical investigator |
| Laiko General Hospital Of Athens | Athens | Greece | Clinical investigator |
Urgent safety measures 1 · Art. 54 CTR
Urgent safety measure US-114425
- Event date
- 2025-12-19
- Submission date
- 2026-01-16
- In response to
- OTHER
- Member states affected
- Austria, Belgium, France, Germany, Greece, Italy, Spain
- Event description
- Please see supporting notification
- Measures taken
- Please see supporting notification
Unexpected events 1 · Art. 53 CTR
Note: SUSARs are reported via EudraVigilance, not CTIS — events shown here are CTIS-public notifications only.
Unexpected event UE-112608
- Event date
- 2025-12-19
- Date aware
- 2025-12-19
- Submission date
- 2025-12-22
- Member states affected
- Austria, Belgium, France, Germany, Greece, Italy, Spain
- Event description
- Please see supporting notification
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Summary of results Art. 37(4) CTR
| Title | Submission date | Status | Type |
|---|---|---|---|
| Summary of Results SUM-127208
|
2026-04-02T12:22:32 | Submitted | Summary of Results |
Layperson summary Annex V
| Title | Submission date | Status | Type |
|---|---|---|---|
| Summary of Results (Layperson) | 2026-04-02T12:49:03 | Submitted | Laypersons Summary of Results |
Documents 65 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Laypersons summary of results (for publication) | 2024-511281-36_Summary of Results_Laypersons_Dutch | 1 |
| Laypersons summary of results (for publication) | 2024-511281-36_Summary of Results_Laypersons_English | 1 |
| Laypersons summary of results (for publication) | 2024-511281-36_Summary of Results_Laypersons_French | 1 |
| Laypersons summary of results (for publication) | 2024-511281-36_Summary of Results_Laypersons_German | 1 |
| Laypersons summary of results (for publication) | 2024-511281-36_Summary of Results_Laypersons_Greek | 1 |
| Laypersons summary of results (for publication) | 2024-511281-36_Summary of Results_Laypersons_Italian | 1 |
| Laypersons summary of results (for publication) | 2024-511281-36_Summary of Results_Laypersons_Spanish | 1 |
| Protocol (for publication) | D1_Protocol_2024-511281-36_EN_REDACTED | 4 |
| Protocol (for publication) | D1_Protocol_2024-511281-36_GR_REDACTED | 4 |
| Recruitment arrangements (for publication) | K1_Recruitment and Informed consent procedure | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements | NA |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Information_Fact sheet_BE-FR_public | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Information_Fact sheet_BE-NL_public | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Fact Sheet_Redacted | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Fact Sheet_redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Physician Referral Letter_Redacted | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Physician Referral Letter_Redacted | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Referral Letter_Redacted | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Study Fact Sheet_Redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Study Recruitment Information_Fact Sheet_Redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Study Recruitment Information_Fact Sheet_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Materials Fact sheet_Study Recruitment Information - Public | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Materials GP Information Letter - Public | 3.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Materials Referral Letter - Public | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Materials_Referral Letter_Redacted | 2.0 |
| Recruitment arrangements (for publication) | K2_Referral Letter_BE-FR_public | 2.0 |
| Recruitment arrangements (for publication) | K2_Referral Letter_BE-NL_public | 2.0 |
| Subject information and informed consent form (for publication) | L_SIS and ICF Pregnancy - Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_centre-specific contact list - Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main - Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_BE-FR_public | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_BE-NL_public | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_FR_Redacted | 4.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_Redacted | 4.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner_BE-FR_public | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner_BE-NL_public | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner_FR_Redacted | 2.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Privacy_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_redacted | 4.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Exploratory Research_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Exploratory Research_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnancy FU_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_GP Information Letter_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient Reimbursement Form_Redacted | 1.0 |
| Summary of results (for publication) | 2024-511281-36_Summary of Results | 1 |
| Synopsis of the protocol (for publication) | D1_Laypersons protocol synopsis_DE_2024-511281-36 | 1 |
| Synopsis of the protocol (for publication) | D1_Laypersons protocol synopsis_EN_2024-511281-36 | 1 |
| Synopsis of the protocol (for publication) | D1_Laypersons protocol synopsis_ES_2024-511281-36 | 1 |
| Synopsis of the protocol (for publication) | D1_Laypersons protocol synopsis_FR_2024-511281-36 | 1 |
| Synopsis of the protocol (for publication) | D1_Laypersons protocol synopsis_GR_2024-511281-36 | 1 |
| Synopsis of the protocol (for publication) | D1_Laypersons protocol synopsis_IT_2024-511281-36 | 1 |
| Synopsis of the protocol (for publication) | D1_Laypersons protocol synopsis_NL_2024-511281-36 | 1 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-15 | Austria | Acceptable 2024-12-06
|
2024-12-06 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-01-23 | Austria | Acceptable 2024-12-06
|
2025-01-23 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-02-12 | Austria | Acceptable 2025-05-13
|
2025-05-14 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-06-19 | Acceptable 2025-05-13
|
2025-06-19 | |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2025-09-05 | Austria | Acceptable 2025-05-13
|
2025-09-05 |