Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ended
Participants planned
63
Countries
8
Sites
27
Cystic fibrosis
Efficacy of nebulized BX004 on sputum PsA burden in CF subjects with chronic PsA pulmonary infection at 8 weeks of treatment (end of treatment [EOT])
Key facts
- Sponsor
- Biomx Ltd.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Respiratory Tract Diseases [C08]
- Trial duration
- 18 Aug 2025 → 8 Dec 2025
- Decision date (initial)
- 2025-08-04
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- No
- Funding sources
- BiomX Ltd.
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Others, Efficacy, Safety
Efficacy of nebulized BX004 on sputum PsA burden in CF subjects with chronic PsA pulmonary infection at 8 weeks of treatment (end of treatment [EOT])
Secondary objectives 4
- Clinical efficacy of nebulized BX004 (lung function and quality of life patient reported outcomes) at various timepoints
- Efficacy of nebulized BX004 on sputum PsA burden in CF subjects with chronic PsA pulmonary infection at various timepoints
- Efficacy of BX004 in obtaining negative sputum cultures for PsA at various timepoints
- Safety and tolerability of nebulized BX004
Conditions and MedDRA coding
Cystic fibrosis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 27.0 | PT | 10074549 | Cystic fibrosis respiratory infection suppression | 100000004865 |
Regulatory references
- Scientific advice from competent authorities
- Health Products Regulatory Authority, Federal Institute For Drugs And Medical Devices
- Plan to share IPD
- No
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 6
- Cystic fibrosis patients with chronic Pseudomonas aeruginosa (PsA) pulmonary infection receiving standard of care CF medications
- Age at least 18 years
- FEV1 between 40-80% predicted
- Clinically stable lung disease
- On inhaled antibiotics for Pseudomonas aeruginosa either as a cycling regimen OR continuous regimen (OR no antibiotics)
- Willing and able to provide adequate sputum samples, using any method (spontaneously expectorated or induced, from home or clinic) at study visits
Exclusion criteria 11
- Known hypersensitivity to bacteriophages or excipients in the formulation
- Receipt of prior bacteriophage therapy within 6 months prior to Screening or Day 1
- Detection of Burkholderia cenocepacia within 1 year prior to Screening or Screening culture
- Currently receiving systemic treatment for allergic bronchopulmonary aspergillosis
- Currently receiving treatment for active infection with non-tuberculous mycobacteria or prior detection of Mycobacterium abscessus in 12 months prior to Screening
- History of severe neutropenia
- Acquired or primary immunodeficiency syndrome
- History of lung transplant
- History of solid organ transplant
- Initiation or change in type of CFTR modulator less than 3 months prior to Screening
- Pregnant or breastfeeding female
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Change from baseline in PsA CFU/g of sputum at 8 weeks of treatment (D57 [EOT])
Secondary endpoints 5
- Change from baseline in lung function (% predicted FEV1) at study visits
- Change from baseline in quality of life assessments, using: o Cystic Fibrosis Questionnaire - Revised (CFQ-R) respiratory domain, and o Cystic Fibrosis Respiratory Symptom Diary and Chronic Respiratory Infection Symptom Score (CFRSD-CRISS)
- Change from baseline in PsA CFU/g of sputum at study visits
- Efficacy of BX004 on sputum culture conversion
- Incidence of treatment-emergent adverse events and change in vital signs, lung exam, blood tests and spirometry
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD12183003 · Product
- Active substance
- IHMA-2121771-1
- Pharmaceutical form
- INHALATION SOLUTION
- Route of administration
- INHALATION
- Max daily dose
- 10 ml millilitre(s)
- Max total dose
- 10 ml millilitre(s)
- Max treatment duration
- 60 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- BIOMX LTD.
- Paediatric formulation
- No
- Orphan designation
- No
Placebo 1
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
Biomx Ltd.
- Sponsor organisation
- Biomx Ltd.
- Address
- Floor 5, 22 Einstein Str 22 Einstein Str
- City
- Ness Ziona
- Postcode
- 7414003
- Country
- Israel
Scientific contact point
- Organisation
- Biomx Ltd.
- Contact name
- Urania Rappo
Public contact point
- Organisation
- Biomx Ltd.
- Contact name
- Urania Rappo
Third parties 8
| Organisation | City, country | Duties |
|---|---|---|
| PARI Pharma GmbH ORG-100002243
|
Starnberg, Germany | Other |
| Dokumeds SIA ORG-100034753
|
Riga, Latvia | On site monitoring, Code 12, Code 13, Code 5, Code 8 |
| Rho Inc. ORG-100048371
|
Durham, United States | Other, Data management, E-data capture |
| Almac Clinical Services Limited ORG-100017464
|
Craigavon, United Kingdom (Northern Ireland) | Code 14, Other |
| Suvoda LLC ORG-100043523
|
Conshohocken, United States | Interactive response technologies (IRT) |
| Icon Clinical Research Limited ORG-100008322
|
Dublin 18, Ireland | Laboratory analysis |
| Medidata Solutions Inc. ORG-100016256
|
New York, United States | Other |
| Greenphire LLC ORG-100041621
|
King Of Prussia, United States | Other |
Locations
8 EU/EEA countries · 27 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Czechia | Ended | 4 | 2 |
| France | Ended | 4 | 4 |
| Germany | Ended | 8 | 6 |
| Ireland | Ended | 4 | 2 |
| Italy | Ended | 4 | 3 |
| Netherlands | Ended | 4 | 3 |
| Poland | Ended | 4 | 3 |
| Spain | Ended | 8 | 4 |
| Rest of world
United States, United Kingdom
|
— | 23 | — |
Investigational sites
Fakultni Nemocnice Brno
Clinic of Pulmonary diseases and tuberculosis, Jihlavska 340/20, Bohunice, Brno
Fakultni Nemocnice V Motole
Department of Medical Microbiology, V Uvalu 84/1, Motol, Prague
Fondation Ildys
Perharidy Center, Lieu Dit Perharidy, 29680, Roscoff
Assistance Publique Hopitaux De Paris
Physiology department, 27 Rue Du Faubourg Saint Jacques, 75014, Paris
Hospices Civils De Lyon
Internal Medicine and Vascular Pathology Department, 165 Chemin Du Grand Revoyet, 69310, Pierre Benite
Centre Hospitalier Universitaire De Montpellier
pediatric and adult department at CF Center, 371 Avenue Du Doyen Gaston Giraud, 34091, Montpellier Cedex 5
LMU Klinikum Muenchen AöR
Pneumology department, Ziemssenstrasse 5, 80336, Munich
Charite Universitaetsmedizin Berlin KöR
Department of Pediatric Pulmonology, Immunology and Critical Care Medicine, Augustenburger Platz 1, Wedding, Berlin
Goethe University Frankfurt
Pneumology department, Theodor-Stern-Kai 7, 60590, Frankfurt Am Main
Universitaetsklinikum Jena KöR
Pediatric and Adolescent medicine Department, Am Klinikum 1, Lobeda, Jena
Universitaetsklinikum Essen AöR
Department of CF and Pulmonary Medicine, Hufelandstrasse 55, Holsterhausen, Essen
University Hospital Cologne AöR
CF Clinical Research Center Cologne, Kerpener Strasse 62, Lindenthal, Cologne
St Vincent's University Hospital
Department of Respiratory Medicine, Elm Park Merrion Road, D04 T6F4, Dublin 4
Cork University Hospital
Adult CF Centre, Wilton, T12 DC4A, Cork
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Dipartimento di Pneuomologia - Clinical Trial Office Padiglione De Palo, Via Francesco Sforza 28, 20122, Milan
Azienda Ospedaliera Universitaria Gaetano Martino Messina
Dipartimento di Pediatria, Unità di Fibrosi Cistica e Gastroenterologia Pediatrica, Via Consolare Valeria N 1, 98124, Messina
Azienda Ospedaliera Universitaria Meyer IRCCS
Pediatrics department, Viale Gaetano Pieraccini 24, 50139, Florence
Amsterdam UMC Stichting
Pulmonology, Meibergdreef 9, 1105 AZ, Amsterdam
Haga Hospital
Pulmonology, Els Borst-Eilersplein 275, 2545 AA, 's-Gravenhage
Universitair Medisch Centrum Utrecht
Pulmonology, Heidelberglaan 100, 3584 CX, Utrecht
Uniwersytecki Szpital Kliniczny W Poznaniu
Klinika Pulmonologii, Alergologii i Onkologii Pulmonologicznej, Ul. Augustyna Szamarzewskiego 84, 60-569, Poznan
Szpital Dzieciecy Polanki Im. Macieja Plazynskiego W Gdansku Sp. z o.o.
Poradnia Leczenia Mukowiscydozy, Ul. Polanki 119, 80-308, Gdansk
National Institute Of Tuberculosis And Lung Diseases
Klinika Pneumonologii i Mukowiscydozy, Ul. Curie-Sklodowskiej 2, 34-700, Rabka-Zdroj
Hospital Universitario Y Politecnico La Fe
Lung Transplant and Cystic Fibrosis Unit, Avenida Fernando Abril Martorell 106, 46026, Valencia
University Clinical Hospital Virgen De La Arrixaca
Pediatric Pneumology and Cystic Fibrosis Unit, Carretera Madrid-Cartagena S/N, El Palmar, Murcia
University Hospital Virgen Del Rocio S.L.
Cystic Fibrosis Unit. Medical surgical unit of respiratory diseases, Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital Universitari Vall D Hebron
Respiratory Department, 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 |
|---|---|---|---|---|---|
| Czechia | 2025-09-22 | 2025-10-02 | 2025-11-20 | ||
| France | 2025-09-19 | 2025-10-28 | 2025-11-20 | ||
| Germany | 2025-08-26 | 2025-10-14 | 2025-11-20 | ||
| Ireland | 2025-08-26 | ||||
| Italy | 2025-10-20 | ||||
| Netherlands | 2025-09-04 | 2025-10-13 | 2025-11-20 | ||
| Poland | 2025-09-10 | 2025-10-07 | 2025-11-20 | ||
| Spain | 2025-08-18 | 2025-09-15 | 2025-11-20 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 8 · Art. 38 CTR
Temporary halt TH-109362
- Halt date
- 2025-11-20
- Planned restart
- 2026-02-23
- Member states concerned
- Poland
- Publication date
- 2025-12-03
- Reason
- Safety related (clinical or pre-clinical results)
- Explanation
- Following DMC evaluation and two ad hoc meetings, it was recommended to pause the study, in order to adapt the study design, to reduce the risk of respiratory AEs.
- Follow-up measures
- During the study treatment pause, randomized subjects will continue protocolspecified clinic visits, but without study drug dosing.
BiomX is continuing to evaluate the optimal modifications to the study design, and will update Investigators and Regulatory Authorities as soon as the new design is finalized;
Details of AEs will be communicated to investigators and subjects before implementing the new design;
The protocol amendment will be submitted for approval to the Regulatory Authorities as soon as possible - Benefit-risk balance changed
- Yes
- Treatment stopped
- Yes
Temporary halt TH-109352
- Halt date
- 2025-11-20
- Planned restart
- 2026-02-23
- Member states concerned
- France
- Publication date
- 2025-12-03
- Reason
- Safety related (clinical or pre-clinical results)
- Explanation
- Following DMC evaluation and two ad hoc meetings, it was recommended to pause the study, in order to adapt the study design, to reduce the risk of respiratory AEs.
- Follow-up measures
- During the study treatment pause, randomized subjects will continue protocolspecified clinic visits, but without study drug dosing.
BiomX is continuing to evaluate the optimal modifications to the study design, and will update Investigators and Regulatory Authorities as soon as the new design is finalized;
Details of AEs will be communicated to investigators and subjects before implementing the new design;
The protocol amendment will be submitted for approval to the Regulatory Authorities as soon as possible - Benefit-risk balance changed
- Yes
- Treatment stopped
- Yes
Temporary halt TH-109360
- Halt date
- 2025-11-20
- Planned restart
- 2026-02-23
- Member states concerned
- Netherlands
- Publication date
- 2025-12-03
- Reason
- Safety related (clinical or pre-clinical results)
- Explanation
- Following DMC evaluation and two ad hoc meetings, it was recommended to pause the study, in order to adapt the study design, to reduce the risk of respiratory AEs.
- Follow-up measures
- During the study treatment pause, randomized subjects will continue protocolspecified clinic visits, but without study drug dosing.
BiomX is continuing to evaluate the optimal modifications to the study design, and will update Investigators and Regulatory Authorities as soon as the new design is finalized;
Details of AEs will be communicated to investigators and subjects before implementing the new design;
The protocol amendment will be submitted for approval to the Regulatory Authorities as soon as possible - Benefit-risk balance changed
- Yes
- Treatment stopped
- Yes
Temporary halt TH-109350
- Halt date
- 2025-11-20
- Planned restart
- 2026-02-23
- Member states concerned
- Czechia
- Publication date
- 2025-12-03
- Reason
- Safety related (clinical or pre-clinical results)
- Explanation
- Following DMC evaluation and two ad hoc meetings, it was recommended to pause the study, in order to adapt the study design, to reduce the risk of respiratory AEs.
- Follow-up measures
- During the study treatment pause, randomized subjects will continue protocolspecified clinic visits, but without study drug dosing.
BiomX is continuing to evaluate the optimal modifications to the study design, and will update Investigators and Regulatory Authorities as soon as the new design is finalized;
Details of AEs will be communicated to investigators and subjects before implementing the new design;
The protocol amendment will be submitted for approval to the Regulatory Authorities as soon as possible - Benefit-risk balance changed
- Yes
- Treatment stopped
- Yes
Temporary halt TH-109357
- Halt date
- 2025-11-20
- Planned restart
- 2026-02-23
- Member states concerned
- Italy
- Publication date
- 2025-12-03
- Reason
- Safety related (clinical or pre-clinical results)
- Explanation
- Following DMC evaluation and two ad hoc meetings, it was recommended to pause the study, in order to adapt the study design, to reduce the risk of respiratory AEs.
- Follow-up measures
- During the study treatment pause, randomized subjects will continue protocolspecified clinic visits, but without study drug dosing.
BiomX is continuing to evaluate the optimal modifications to the study design, and will update Investigators and Regulatory Authorities as soon as the new design is finalized;
Details of AEs will be communicated to investigators and subjects before implementing the new design;
The protocol amendment will be submitted for approval to the Regulatory Authorities as soon as possible - Benefit-risk balance changed
- Yes
- Treatment stopped
- Yes
Temporary halt TH-109358
- Halt date
- 2025-11-20
- Planned restart
- 2026-02-23
- Member states concerned
- Spain
- Publication date
- 2025-12-03
- Reason
- Safety related (clinical or pre-clinical results)
- Explanation
- Following DMC evaluation and two ad hoc meetings, it was recommended to pause the study, in order to adapt the study design, to reduce the risk of respiratory AEs.
- Follow-up measures
- During the study treatment pause, randomized subjects will continue protocolspecified clinic visits, but without study drug dosing.
BiomX is continuing to evaluate the optimal modifications to the study design, and will update Investigators and Regulatory Authorities as soon as the new design is finalized;
Details of AEs will be communicated to investigators and subjects before implementing the new design;
The protocol amendment will be submitted for approval to the Regulatory Authorities as soon as possible - Benefit-risk balance changed
- Yes
- Treatment stopped
- Yes
Temporary halt TH-109356
- Halt date
- 2025-11-20
- Planned restart
- 2026-02-23
- Member states concerned
- Ireland
- Publication date
- 2025-12-03
- Reason
- Safety related (clinical or pre-clinical results)
- Explanation
- Following DMC evaluation and two ad hoc meetings, it was recommended to pause the study, in order to adapt the study design, to reduce the risk of respiratory AEs.
- Follow-up measures
- During the study treatment pause, randomized subjects will continue protocolspecified clinic visits, but without study drug dosing.
BiomX is continuing to evaluate the optimal modifications to the study design, and will update Investigators and Regulatory Authorities as soon as the new design is finalized;
Details of AEs will be communicated to investigators and subjects before implementing the new design;
The protocol amendment will be submitted for approval to the Regulatory Authorities as soon as possible - Benefit-risk balance changed
- Yes
- Treatment stopped
- Yes
Temporary halt TH-109354
- Halt date
- 2025-11-20
- Planned restart
- 2026-02-23
- Member states concerned
- Germany
- Publication date
- 2025-12-03
- Reason
- Safety related (clinical or pre-clinical results)
- Explanation
- Following DMC evaluation and two ad hoc meetings, it was recommended to pause the study, in order to adapt the study design, to reduce the risk of respiratory AEs.
- Follow-up measures
- During the study treatment pause, randomized subjects will continue protocolspecified clinic visits, but without study drug dosing.
BiomX is continuing to evaluate the optimal modifications to the study design, and will update Investigators and Regulatory Authorities as soon as the new design is finalized;
Details of AEs will be communicated to investigators and subjects before implementing the new design;
The protocol amendment will be submitted for approval to the Regulatory Authorities as soon as possible - Benefit-risk balance changed
- Yes
- Treatment stopped
- Yes
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 188 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_BMX-04-002_Administrative letter_Address in Protocol_Redacted | NA |
| Protocol (for publication) | D1_BMX-04-002_Protocol_2024-519856-94_redacted | 1.1—EU |
| Protocol (for publication) | D4_Patient Facing Document_CZE_Czech_PGIS and PGIC_Redacted | 1.0 |
| Protocol (for publication) | D4_Patient Facing Document_CZE_Czech_questionnaire CFQ-R | 2.0 |
| Protocol (for publication) | D4_Patient Facing Document_CZE_Czech_questionnaire CFRSD | 2.0 |
| Protocol (for publication) | D4_Patient Facing Document_DEU_German_PGIS and PGIC_Redacted | 1.0 |
| Protocol (for publication) | D4_Patient Facing Document_DEU_German_questionnaire CFQ-R | 2.0 |
| Protocol (for publication) | D4_Patient Facing Document_DEU_German_questionnaire CFRSD | 2.0 |
| Protocol (for publication) | D4_Patient Facing Document_ESP_Spanish_PGIS and PGIC_Redacted | 1.0 |
| Protocol (for publication) | D4_Patient Facing Document_ESP_Spanish_questionnaire CFQ-R | 2.0 |
| Protocol (for publication) | D4_Patient Facing Document_ESP_Spanish_questionnaire CFRSD | 2.0 |
| Protocol (for publication) | D4_Patient Facing Document_FRA_French_PGIS and PGIC_Redacted | 1.0 |
| Protocol (for publication) | D4_Patient Facing Document_FRA_French_questionnaire CFQ-R | 2.0 |
| Protocol (for publication) | D4_Patient Facing Document_FRA_French_questionnaire CFRSD | 2.0 |
| Protocol (for publication) | D4_Patient Facing Document_IRL_English_PGIS and PGIC_Redacted | 1.0 |
| Protocol (for publication) | D4_Patient Facing Document_IRL_English_questionnaire CFQ-R | 2.0 |
| Protocol (for publication) | D4_Patient Facing Document_IRL_English_questionnaire CFRSD | 2.0 |
| Protocol (for publication) | D4_Patient Facing Document_ITA_Italian_PGIS and PGIC_Redacted | 1.0 |
| Protocol (for publication) | D4_Patient Facing Document_ITA_Italian_questionnaire CFQ-R | 2.0 |
| Protocol (for publication) | D4_Patient Facing Document_ITA_Italian_questionnaire CFRSD | 2.0 |
| Protocol (for publication) | D4_Patient Facing Document_NLD_Dutch_PGIS and PGIC_Redacted | 1.0 |
| Protocol (for publication) | D4_Patient Facing Document_NLD_Dutch_questionnaire CFQ-R | 2.0 |
| Protocol (for publication) | D4_Patient Facing Document_NLD_Dutch_questionnaire CFRSD | 2.0 |
| Protocol (for publication) | D4_Patient Facing Document_POL_Polish_PGIS and PGIC_Redacted | 1.0 |
| Protocol (for publication) | D4_Patient Facing Document_POL_Polish_questionnaire CFQ-R | 2.0 |
| Protocol (for publication) | D4_Patient Facing Document_POL_Polish_questionnaire CFRSD | 2.0 |
| Recruitment arrangements (for publication) | K1_BMX-04-002_Recruitment and Informed consent procedure template_DEU | 1.0 |
| Recruitment arrangements (for publication) | K1_BMX-04-002_Recruitment and Informed consent procedure template_ESP | 1.0 |
| Recruitment arrangements (for publication) | K1_BMX-04-002_Recruitment and Informed consent procedure template_FRA | 2.0 |
| Recruitment arrangements (for publication) | K1_BMX-04-002_Recruitment and Informed consent procedure template_IRL | 1.0 |
| Recruitment arrangements (for publication) | K1_BMX-04-002_Recruitment and Informed consent procedure template_ITA | 1.0 |
| Recruitment arrangements (for publication) | K1_BMX-04-002_Recruitment and Informed consent procedure template_NLD | 2.0 |
| Recruitment arrangements (for publication) | K1_BMX-04-002_Recruitment and Informed consent procedure template_POL | 1.0 |
| Recruitment arrangements (for publication) | K1_BMX-04-002_Recruitment and informed consent template_CZE | 1.0 |
| Subject information and informed consent form (for publication) | L1_ BMX-04-002_PARI ICF_CZE_Czech_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_ BMX-04-002_PARI ICF_IRL_English_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_ BMX-04-002_PARI ICF_POL_Poland_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_ BMX-04-002_PARI IF_FRA_French_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_ BMX-04-002_SIS and ICF_for future research of biosamples _DEU_German_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_ BMX-04-002_SIS and ICF_for future research of biosamples _ITA_Italian_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_ BMX-04-002_SIS and ICF_Main_CZE_Czech_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_ BMX-04-002_SIS and ICF_Main_DEU_German_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_ BMX-04-002_SIS and ICF_Main_FRA_French_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_ BMX-04-002_SIS and ICF_Main_IRL_English_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_ BMX-04-002_SIS and ICF_Main_ITA_Italian_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_ BMX-04-002_SIS and ICF_Main_NLD_Dutch_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_ BMX-04-002_SIS and ICF_Main_POL_Polish_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_ BMX-04-002_SIS and ICF_Pregnant Partner and Pregnancy FU_CZE_Czech_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_ BMX-04-002_SIS and ICF_Pregnant Partner and Pregnancy FU_DEU_German_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_ BMX-04-002_SIS and ICF_Pregnant Partner and Pregnancy FU_FRA_French_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_ BMX-04-002_SIS and ICF_Pregnant Partner and Pregnancy FU_ITA_Italian_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_ BMX-04-002_SIS and ICF_Pregnant Partner and Pregnancy FU_NLD_Dutch_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_ BMX-04-002_SIS and ICF_Pregnant Partner and Pregnancy FU_POL_Polish_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_ BMX-04-002_SIS and ICF_Pregnant Partner_IRL_English_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_BMX-04-002_Data Privacy Notification_CZE_Czech_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_BMX-04-002_Data Privacy Notification_ITA_Italian_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_BMX-04-002_PARI ICF_DEU_German_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_BMX-04-002_PARI ICF_ITA_Italian_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_BMX-04-002_PARI ICF_NLD_Dutch_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_BMX-04-002_PARI_ICF_ESP_Spanish_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_BMX-04-002_SIS and ICF_Main_ESP_Spanish_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_BMX-04-002_SIS and ICF_Pregnant Partner and Pregnancy FU_ESP_Spanish_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_BMX-04-002_SIS and ICF_Reimbursement_DEU_German | 1.0 |
| Subject information and informed consent form (for publication) | L1_BMX-04-002_SIS and ICF_Reimbursement_ESP_Spanish | 1.0 |
| Subject information and informed consent form (for publication) | L1_BMX-04-002_SIS and ICF_Reimbursement_FRA_French | 1.0 |
| Subject information and informed consent form (for publication) | L1_BMX-04-002_SIS and ICF_Reimbursement_IRL_English | 1.0 |
| Subject information and informed consent form (for publication) | L1_BMX-04-002_SIS and ICF_Reimbursement_POL_Polish | 1.0 |
| Subject information and informed consent form (for publication) | L2_BMX-04-002_Other subject information_3D Secure Terms of Use_POL | 10.0 |
| Subject information and informed consent form (for publication) | L2_BMX-04-002_Other subject information_Antibiotic Dosing Diary_CZE | 1 |
| Subject information and informed consent form (for publication) | L2_BMX-04-002_Other subject information_Antibiotic Dosing Diary_DEU | 1 |
| Subject information and informed consent form (for publication) | L2_BMX-04-002_Other subject information_Antibiotic Dosing Diary_ESP | 1 |
| Subject information and informed consent form (for publication) | L2_BMX-04-002_Other subject information_Antibiotic Dosing Diary_FRA | 1 |
| Subject information and informed consent form (for publication) | L2_BMX-04-002_Other subject information_Antibiotic Dosing Diary_IRL | 1 |
| Subject information and informed consent form (for publication) | L2_BMX-04-002_Other subject information_Antibiotic Dosing Diary_ITA | 1 |
| Subject information and informed consent form (for publication) | L2_BMX-04-002_Other subject information_Antibiotic Dosing Diary_POL | 1 |
| Subject information and informed consent form (for publication) | L2_BMX-04-002_Other subject information_Bank Transfer FAQ_POL | 10.0 |
| Subject information and informed consent form (for publication) | L2_BMX-04-002_Other subject information_Bank Transfer Standard Message Template_POL | 10.0 |
| Subject information and informed consent form (for publication) | L2_BMX-04-002_Other subject information_ClinCard Cardholder FAQ_POL | 11.0 |
| Subject information and informed consent form (for publication) | L2_BMX-04-002_Other subject information_ClinCard Cardholder Msg Templates_POL | 10.0 |
| Subject information and informed consent form (for publication) | L2_BMX-04-002_Other subject information_ClinCard Cardholder Website Screenshots_MC_Europe | 10.1 |
| Subject information and informed consent form (for publication) | L2_BMX-04-002_Other subject information_ClinCard KYC and Card Activation Msg Templates_POL | 10.0 |
| Subject information and informed consent form (for publication) | L2_BMX-04-002_Other subject information_ClinCard_Card_Carrier_POL | 10.1 |
| Subject information and informed consent form (for publication) | L2_BMX-04-002_Other subject information_ClinCard_Fee_Schedule_POL | 10.1 |
| Subject information and informed consent form (for publication) | L2_BMX-04-002_Other subject information_ClinCard_Generic_Image | 10.0 |
| Subject information and informed consent form (for publication) | L2_BMX-04-002_Other subject information_ClinCard_Privacy Policy_TPML_MC_POL | 10.0 |
| Subject information and informed consent form (for publication) | L2_BMX-04-002_Other subject information_ConneX Travel Contact Card_IC_POL | 10.0 |
| Subject information and informed consent form (for publication) | L2_BMX-04-002_Other subject information_ConneX Travel Reference Guide for Participants_IC_POL | 10.0 |
| Subject information and informed consent form (for publication) | L2_BMX-04-002_Other subject information_EU Dispute Form_POL | 10.0 |
| Subject information and informed consent form (for publication) | L2_BMX-04-002_Other subject information_Greenphire LLC Privacy_Policy_POL | 11.0 |
| Subject information and informed consent form (for publication) | L2_BMX-04-002_Other subject information_GreenSpace Account Information Change_POL | 10.0 |
| Subject information and informed consent form (for publication) | L2_BMX-04-002_Other subject information_GreenSpace Participant Email Template_POL | 10.0 |
| Subject information and informed consent form (for publication) | L2_BMX-04-002_Other subject information_GreenSpace Participant FAQ_Bank_Transfer_POL | 10.0 |
| Subject information and informed consent form (for publication) | L2_BMX-04-002_Other subject information_GreenSpace Participant FAQ_Cardholder_POL | 10.0 |
| Subject information and informed consent form (for publication) | L2_BMX-04-002_Other subject information_GreenSpace Participant Forgot Password Email Template_POL | 10.0 |
| Subject information and informed consent form (for publication) | L2_BMX-04-002_Other subject information_Greenspace Terms of Use_POL | 10.0 |
| Subject information and informed consent form (for publication) | L2_BMX-04-002_Other subject information_Home Sputum Sample Collection Instructions_CZE_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_BMX-04-002_Other subject information_Home Sputum Sample Collection Instructions_DEU_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_BMX-04-002_Other subject information_Home Sputum Sample Collection Instructions_ESP_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_BMX-04-002_Other subject information_Home Sputum Sample Collection Instructions_FRA_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_BMX-04-002_Other subject information_Home Sputum Sample Collection Instructions_IRL_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_BMX-04-002_Other subject information_Home Sputum Sample Collection Instructions_ITA_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_BMX-04-002_Other subject information_Home Sputum Sample Collection Instructions_POL_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_BMX-04-002_Other subject information_IFU_IMP administration_CZE_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_BMX-04-002_Other subject information_IFU_IMP administration_DEU_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_BMX-04-002_Other subject information_IFU_IMP administration_ESP_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_BMX-04-002_Other subject information_IFU_IMP administration_FRA_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_BMX-04-002_Other subject information_IFU_IMP administration_IRL_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_BMX-04-002_Other subject information_IFU_IMP administration_ITA_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_BMX-04-002_Other subject information_IFU_IMP administration_POL_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_BMX-04-002_Other subject information_KYC Identity Verification for ClinCard_POL | 10.1 |
| Subject information and informed consent form (for publication) | L2_BMX-04-002_Other subject information_Medidata Data Privacy Notice_CZE | NA |
| Subject information and informed consent form (for publication) | L2_BMX-04-002_Other subject information_Medidata Data Privacy Notice_DEU | NA |
| Subject information and informed consent form (for publication) | L2_BMX-04-002_Other subject information_Medidata Data Privacy Notice_ESP | NA |
| Subject information and informed consent form (for publication) | L2_BMX-04-002_Other subject information_Medidata Data Privacy Notice_FRA | NA |
| Subject information and informed consent form (for publication) | L2_BMX-04-002_Other subject information_Medidata Data Privacy Notice_IRL | NA |
| Subject information and informed consent form (for publication) | L2_BMX-04-002_Other subject information_Medidata Data Privacy Notice_ITA | NA |
| Subject information and informed consent form (for publication) | L2_BMX-04-002_Other subject information_Medidata Data Privacy Notice_NLD | NA |
| Subject information and informed consent form (for publication) | L2_BMX-04-002_Other subject information_Medidata Data Privacy Notice_POL | NA |
| Subject information and informed consent form (for publication) | L2_BMX-04-002_Other subject information_Medidata Patient Cloud App Standard Screens_CZE | 2.5 |
| Subject information and informed consent form (for publication) | L2_BMX-04-002_Other subject information_Medidata Patient Cloud App Standard Screens_DEU | 2.7 |
| Subject information and informed consent form (for publication) | L2_BMX-04-002_Other subject information_Medidata Patient Cloud App Standard Screens_IRL | 2.7 |
| Subject information and informed consent form (for publication) | L2_BMX-04-002_Other subject information_Medidata_Standard Patient Cloud App Screens_ESP | 2.5 |
| Subject information and informed consent form (for publication) | L2_BMX-04-002_Other subject information_Medidata_Standard Patient Cloud App Screens_FRA | 2.5 |
| Subject information and informed consent form (for publication) | L2_BMX-04-002_Other subject information_Medidata_Standard Patient Cloud App Screens_ITA | 2.5 |
| Subject information and informed consent form (for publication) | L2_BMX-04-002_Other subject information_Medidata_Standard Patient Cloud App Screens_POL | 2.5 |
| Subject information and informed consent form (for publication) | L2_BMX-04-002_Other subject information_Package insert for bottle sterilizer_CZE | NA |
| Subject information and informed consent form (for publication) | L2_BMX-04-002_Other subject information_Package insert for bottle sterilizer_DEU | NA |
| Subject information and informed consent form (for publication) | L2_BMX-04-002_Other subject information_Package insert for bottle sterilizer_ESP | NA |
| Subject information and informed consent form (for publication) | L2_BMX-04-002_Other subject information_Package insert for bottle sterilizer_FRA | NA |
| Subject information and informed consent form (for publication) | L2_BMX-04-002_Other subject information_Package insert for bottle sterilizer_IRL | NA |
| Subject information and informed consent form (for publication) | L2_BMX-04-002_Other subject information_Package insert for bottle sterilizer_ITA | NA |
| Subject information and informed consent form (for publication) | L2_BMX-04-002_Other subject information_Package insert for bottle sterilizer_POL | NA |
| Subject information and informed consent form (for publication) | L2_BMX-04-002_Other subject information_PARI Quickguide Study Connect_CZE_Redacted | NA |
| Subject information and informed consent form (for publication) | L2_BMX-04-002_Other subject information_PARI Quickguide Study Connect_DEU_Redacted | NA |
| Subject information and informed consent form (for publication) | L2_BMX-04-002_Other subject information_PARI Quickguide Study Connect_ESP_Redacted | NA |
| Subject information and informed consent form (for publication) | L2_BMX-04-002_Other subject information_PARI Quickguide Study Connect_FRA_Redacted | NA |
| Subject information and informed consent form (for publication) | L2_BMX-04-002_Other subject information_PARI Quickguide Study Connect_ITA_Redacted | NA |
| Subject information and informed consent form (for publication) | L2_BMX-04-002_Other subject information_PARI Quickguide Study Connect_POL_Redacted | NA |
| Subject information and informed consent form (for publication) | L2_BMX-04-002_Other subject information_PARI Study Connect App_privacy_CZE_Redacted | NA |
| Subject information and informed consent form (for publication) | L2_BMX-04-002_Other subject information_PARI Study Connect App_privacy_DEU_Redacted | NA |
| Subject information and informed consent form (for publication) | L2_BMX-04-002_Other subject information_PARI Study Connect App_privacy_ESP_Redacted | NA |
| Subject information and informed consent form (for publication) | L2_BMX-04-002_Other subject information_PARI Study Connect App_privacy_FRA_Redacted | NA |
| Subject information and informed consent form (for publication) | L2_BMX-04-002_Other subject information_PARI Study Connect App_privacy_IRL_Redacted | NA |
| Subject information and informed consent form (for publication) | L2_BMX-04-002_Other subject information_PARI Study Connect App_privacy_ITA_Redacted | NA |
| Subject information and informed consent form (for publication) | L2_BMX-04-002_Other subject information_PARI Study Connect App_privacy_POL_Redacted | NA |
| Subject information and informed consent form (for publication) | L2_BMX-04-002_Other subject information_PARI Study Connect App_screenshots_CZE_Redacted | NA |
| Subject information and informed consent form (for publication) | L2_BMX-04-002_Other subject information_PARI Study Connect App_Screenshots_DEU_Redacted | NA |
| Subject information and informed consent form (for publication) | L2_BMX-04-002_Other subject information_PARI Study Connect App_screenshots_ESP_Redacted | NA |
| Subject information and informed consent form (for publication) | L2_BMX-04-002_Other subject information_PARI Study Connect App_screenshots_FRA_Redacted | NA |
| Subject information and informed consent form (for publication) | L2_BMX-04-002_Other subject information_PARI Study Connect App_screenshots_IRL_Redacted | NA |
| Subject information and informed consent form (for publication) | L2_BMX-04-002_Other subject information_PARI Study Connect App_screenshots_ITA_Redacted | NA |
| Subject information and informed consent form (for publication) | L2_BMX-04-002_Other subject information_PARI Study Connect App_Screenshots_POL_Redacted | NA |
| Subject information and informed consent form (for publication) | L2_BMX-04-002_Other subject information_PARI Study Connect App_ToU_CZE_Redacted | NA |
| Subject information and informed consent form (for publication) | L2_BMX-04-002_Other subject information_PARI Study Connect App_ToU_DEU_Redacted | NA |
| Subject information and informed consent form (for publication) | L2_BMX-04-002_Other subject information_PARI Study Connect App_ToU_ESP_Redacted | NA |
| Subject information and informed consent form (for publication) | L2_BMX-04-002_Other subject information_PARI Study Connect App_ToU_FRA_Redacted | NA |
| Subject information and informed consent form (for publication) | L2_BMX-04-002_Other subject information_PARI Study Connect App_ToU_IRL_Redacted | NA |
| Subject information and informed consent form (for publication) | L2_BMX-04-002_Other subject information_PARI Study Connect App_ToU_ITA_Redacted | NA |
| Subject information and informed consent form (for publication) | L2_BMX-04-002_Other subject information_PARI Study Connect App_ToU_POL_Redacted | NA |
| Subject information and informed consent form (for publication) | L2_BMX-04-002_Other subject information_PARI Study Invitation_DEU_Redacted | NA |
| Subject information and informed consent form (for publication) | L2_BMX-04-002_Other subject information_PARI Study Invitation_POL_Redacted | NA |
| Subject information and informed consent form (for publication) | L2_BMX-04-002_Other subject information_PARI_eTRACK IFU_ IRL_Redacted | NA |
| Subject information and informed consent form (for publication) | L2_BMX-04-002_Other subject information_PARI_eTRACK IFU_CZE_Redacted | NA |
| Subject information and informed consent form (for publication) | L2_BMX-04-002_Other subject information_PARI_eTRACK IFU_DEU_Redacted | NA |
| Subject information and informed consent form (for publication) | L2_BMX-04-002_Other subject information_PARI_eTRACK IFU_ESP_Redacted | NA |
| Subject information and informed consent form (for publication) | L2_BMX-04-002_Other subject information_PARI_eTRACK IFU_FRA_Redacted | NA |
| Subject information and informed consent form (for publication) | L2_BMX-04-002_Other subject information_PARI_eTRACK IFU_ITA_Redacted | NA |
| Subject information and informed consent form (for publication) | L2_BMX-04-002_Other subject information_PARI_eTRACK IFU_POL_Redacted | NA |
| Subject information and informed consent form (for publication) | L2_BMX-04-002_Other subject information_PARI_study invitation_CZE_Redacted | NA |
| Subject information and informed consent form (for publication) | L2_BMX-04-002_Other subject information_PARI_study invitation_ESP_Redacted | NA |
| Subject information and informed consent form (for publication) | L2_BMX-04-002_Other subject information_PARI_study invitation_FRA_Redacted | NA |
| Subject information and informed consent form (for publication) | L2_BMX-04-002_Other subject information_PARI_study invitation_ITA_Redacted | NA |
| Subject information and informed consent form (for publication) | L2_BMX-04-002_Other subject information_PARI_Study_Invitation_IRL_Redacted | NA |
| Subject information and informed consent form (for publication) | L2_BMX-04-002_Other subject information_Patients Card_ IRL _English | 1.0 |
| Subject information and informed consent form (for publication) | L2_BMX-04-002_Other subject information_Patients Card_CZE_Czech | 1.0 |
| Subject information and informed consent form (for publication) | L2_BMX-04-002_Other subject information_Patients Card_DEU_German | 1.0 |
| Subject information and informed consent form (for publication) | L2_BMX-04-002_Other subject information_Patients Card_ESP_Spanish | 1.0 |
| Subject information and informed consent form (for publication) | L2_BMX-04-002_Other subject information_Patients Card_FRA_French | 1.0 |
| Subject information and informed consent form (for publication) | L2_BMX-04-002_Other subject information_Patients Card_ITA_Italian | 1.0 |
| Subject information and informed consent form (for publication) | L2_BMX-04-002_Other subject information_Patients Card_POL_Polish | 1.0 |
| Synopsis of the protocol (for publication) | D1_BMX-04-002_Layperson Protocol Synopsis_CZE_2024-519856-94-00_Redacted | 1.0 |
| Synopsis of the protocol (for publication) | D1_BMX-04-002_Layperson Protocol Synopsis_DEU_2024-519856-94-00_Redacted | 1.0 |
| Synopsis of the protocol (for publication) | D1_BMX-04-002_Layperson Protocol Synopsis_ENG_2024-519856-94-00_Redacted | 1.0 |
| Synopsis of the protocol (for publication) | D1_BMX-04-002_Layperson Protocol Synopsis_ESP_2024-519856-94-00_Redacted | 1.0 |
| Synopsis of the protocol (for publication) | D1_BMX-04-002_Layperson Protocol Synopsis_FRA_2024-519856-94-00_Redacted | 1.0 |
| Synopsis of the protocol (for publication) | D1_BMX-04-002_Layperson Protocol Synopsis_ITA_2024-519856-94-00_Redacted | 1.0 |
| Synopsis of the protocol (for publication) | D1_BMX-04-002_Layperson Protocol Synopsis_NLD_2024-519856-94-00_Redacted | 1.0 |
| Synopsis of the protocol (for publication) | D1_BMX-04-002_Layperson Protocol Synopsis_POL_2024-519856-94-00_Redacted | 1.0 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-04-14 | Czechia | Acceptable with conditions 2025-08-01
|
2025-08-04 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-08-14 | Czechia | Acceptable with conditions 2025-08-01
|
2025-08-14 |
| 3 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-08-14 | Acceptable with conditions | 2025-09-10 | |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-09-12 | Czechia | 2025-09-12 | |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-10-06 | 2025-10-06 |