Clinical trial • Phase II • Respiratory
AZD0292 for Bronchiectasis with chronic Pseudomonas aeruginosa colonization
Phase II trial of AZD0292 for Bronchiectasis with chronic Pseudomonas aeruginosa colonization.
Overview
- Trial Therapeutic Area
- Respiratory
- Trial Disease
- Bronchiectasis with chronic Pseudomonas aeruginosa colonization
- Trial Stage
- Phase II
- Drug Modality
- Monoclonal antibody
- Paediatric Trial
- Yes
Key dates
- Initial CTIS Submission Date
- 15-07-2025
- First CTIS Authorization Date
- 31-10-2025
Trial design
Randomised, placebo for azd0292 (matching placebo); no dose or schedule specified in the provided ctis metadata-controlled Phase II trial across 50 sites in Italy, Belgium, Greece and others.
- Randomised
- Yes
- Comparator
- Placebo for AZD0292 (matching placebo); no dose or schedule specified in the provided CTIS metadata
- Target Sample Size
- 323
Eligibility
Recruits 323 paediatric patients.
- Pregnancy Exclusion
- Female participants who are pregnant, lactating, or of childbearing potential and not using a highly effective method of contraception or abstinence from at least 4 weeks prior to study intervention administration and until at least 6 months after study intervention administration
- Vulnerable Population
- Vulnerable population flag selected in trial metadata. Eligibility requires participants to be capable of giving signed informed consent. Subject information and informed consent forms (ICFs) are provided (adult and pregnancy-specific ICFs, multiple language versions listed). No specific assent procedures for minors or alternative consent-by-proxy wording are provided in the available materials.
Inclusion criteria
- {"criterion_text":"- Participant must be ≥ 18 years of age at the time of signing the informed consent"}
- {"criterion_text":"- Weight ≥ 35 kg"}
- {"criterion_text":"- Bronchiectasis diagnosed by a physician and confirmed by CT demonstrating abnormal bronchial dilation in ≥ 1 lobe. Note: A historical CT scan within the past 5 years is acceptable. If not available, a CT scan should be conducted at screening to confirm eligibility."}
- {"criterion_text":"- Participants who are receiving appropriate standard of care therapy per local guidelines and have a documented history of ≥ 2 moderate exacerbations or ≥ 1 severe exacerbation in the preceding 12 months requiring antibiotics"}
- {"criterion_text":"- Participants who are clinically stable and free from an exacerbation of bronchiectasis for 4 weeks prior to randomization"}
- {"criterion_text":"- Participants with pre- or post-bronchodilator FEV1 ≥ 25% predicted value at screening."}
- {"criterion_text":"- Presence of positive (PCR or culture) PsA in an airway sample at least once in the last 24 months prior to screening"}
- {"criterion_text":"- Presence of culture positive PsA in sputum at least within 5 weeks of randomization a) Participants who have previously received PsA eradication therapy, as determined appropriate by their treating provider, but remain colonized with PsA are eligible for the study."}
- {"criterion_text":"- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol"}
Exclusion criteria
- {"criterion_text":"- Primary lung diagnosis other than bronchiectasis"}
- {"criterion_text":"- Receipt of investigational products indicated for the treatment or prevention of bronchiectasis exacerbations or expected receipt during the study"}
- {"criterion_text":"- Participants with CF on CFTR modulator therapies which are newly initiated within the previous 3 months prior to screening"}
- {"criterion_text":"- Female participants who are pregnant, lactating, or of childbearing potential and not using a highly effective method of contraception or abstinence from at least 4 weeks prior to study intervention administration and until at least 6 months after study intervention administration"}
- {"criterion_text":"- Evidence of active tuberculosis or active nontuberculous mycobacteria being treated or requiring treatment. Active tuberculosis may be suspected if a participant has a cough for more than 2 weeks with concurrent fever, night sweats, weight loss, or hemoptysis. Investigation for active or latent TB, with interferon gamma release assay (IGRA) and/or chest X-ray, should be considered if deemed clinically indicated by the Investigator. Participants currently receiving treatment for active TB or nontuberculous mycobacteria may be considered after completion of an appropriate course of therapy"}
- {"criterion_text":"- Evidence of an active allergic bronchopulmonary aspergillosis being treated or requiring treatment"}
- {"criterion_text":"- Need for long term supplemental oxygen. Oxygen use for ambulation and relief of breathlessness after exercise is allowed"}
- {"criterion_text":"- Malignancy, current or within the previous 5 years, except for stable prostate cancer, adequately treated non-invasive basal cell and squamous cell carcinoma of the skin and cervical carcinoma in situ treated with apparent success more than one year prior to enrolment"}
- {"criterion_text":"- AIDS or Advanced human immunodeficiency virus disease (CD4 count of < 200 cells/mm3)"}
- {"criterion_text":"- History of severe adverse reaction associated with a mAb, and/or history of severe allergic reaction (eg, anaphylaxis that required the use of epinephrine/adrenaline or hospitalization), and/or history of immune complex disease (Type III hypersensitivity reactions) to monoclonal antibody administration"}
- {"criterion_text":"- Treatment with long term anti-PsA antibiotics, macrolides, or DPP-1 inhibitors, which are newly initiated within the 3 months prior to screening"}
- {"criterion_text":"- Chronic immunosuppressive therapy (including prednisolone > 5 mg or equivalent) newly initiated within the last 3 months"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Annualized rate of exacerbations over a variable follow-up time","definition_or_measurement_approach":"Annualized rate of exacerbations calculated over a variable follow-up period (as stated: 'Annualized rate of exacerbations over a variable follow-up time')"}
Secondary endpoints
- {"endpoint_text":"- Annualized rate of severe exacerbations over a variable follow-up time","definition_or_measurement_approach":"Annualized rate of severe exacerbations over a variable follow-up period"}
- {"endpoint_text":"- Change from baseline in QoL-B-RSS","definition_or_measurement_approach":"Change from baseline measured by the QoL-B Respiratory Symptom Scale Score (QoL-B-RSS)"}
- {"endpoint_text":"- Change from baseline in SGRQ score","definition_or_measurement_approach":"Change from baseline measured by the St George's Respiratory Questionnaire (SGRQ) score"}
- {"endpoint_text":"- Time to first moderate or severe exacerbation and Time to first severe exacerbation","definition_or_measurement_approach":"Time-to-event analyses for time to first moderate or severe exacerbation and time to first severe exacerbation"}
- {"endpoint_text":"- Serum PK concentrations of AZD0292 at all collected timepoints","definition_or_measurement_approach":"Serum pharmacokinetic concentrations measured at all collected timepoints"}
- {"endpoint_text":"- Incidence of ADA to AZD0292 and ADA titers of AZD0292 at all collected timepoints","definition_or_measurement_approach":"Incidence and titers of anti-drug antibodies (ADA) measured at all collected timepoints"}
- {"endpoint_text":"- Occurrence of AEs collected from the first dose through 12 weeks after last IMP administration and SAEs, AESIs, and MAAEs, collected throughout the study","definition_or_measurement_approach":"Safety events collected from first dose through 12 weeks after last IMP for AEs and throughout study for SAEs, adverse events of special interest (AESIs), and medically attended adverse events (MAAEs)"}
Recruitment
- Planned Sample Size
- 323
- Recruitment Window Months
- 31
- Consent Approach
- Participants must provide signed informed consent ('Capable of giving signed informed consent' is an inclusion criterion). Multiple ICF documents are provided including main ICFs and pregnancy-specific ICFs; language-specific ICFs are available (English, French, Dutch, Greek and others as listed). No details on assent for minors are provided in the available documents.
Methods
- K1_Recruitment arrangements documents (country-specific recruitment arrangements provided)
- K2 recruitment materials: Letter to participant (document 'K2_Recruitment material_Letter to participant')
- K2 recruitment materials: Poster for advertisement (document 'K2_Recruitment material_Poster for advertisement')
Geography
- Total Number Of Sites
- 50
- Total Number Of Participants
- 112
Italy
- Earliest CTIS Part Ii Submission Date
- 20-10-2025
- Latest Decision Or Authorization Date
- 04-11-2025
- Processing Time Days
- 15
- Number Of Sites
- 8
- Number Of Participants
- 15
Sites
- Site Name
- Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
- Department Name
- UOC di Pneumologia
- Principal Investigator Name
- Salvatore Battaglia
- Principal Investigator Email
- salvatore.battaglia@unipa.it
- Contact Person Name
- Salvatore Battaglia
- Contact Person Email
- salvatore.battaglia@unipa.it
- Site Name
- Azienda Ospedaliera Di Perugia
- Department Name
- S.C. Pneumologia
- Principal Investigator Name
- Roberto Lipsi
- Principal Investigator Email
- roberto.lipsi@ospedale.perugia.it
- Contact Person Name
- Roberto Lipsi
- Contact Person Email
- roberto.lipsi@ospedale.perugia.it
- Site Name
- Humanitas Mirasole S.p.A.
- Department Name
- UO. Pneumologia 1
- Principal Investigator Name
- Edoardo Simonetta
- Principal Investigator Email
- edoardo.simonetta@humanitas.it
- Contact Person Name
- Edoardo Simonetta
- Contact Person Email
- edoardo.simonetta@humanitas.it
- Site Name
- Irccs San Raffaele Roma S.r.l.
- Department Name
- Cardiopulmonary Rehabilitation
- Principal Investigator Name
- Franco Pasqua
- Principal Investigator Email
- franco.pasqua@sanraffaele.it
- Contact Person Name
- Franco Pasqua
- Contact Person Email
- franco.pasqua@sanraffaele.it
- Site Name
- Fondazione IRCCS Policlinico San Matteo
- Department Name
- S.C. Pneumologia
- Principal Investigator Name
- Angelo Guido Corsico
- Principal Investigator Email
- corsico@unipv.it
- Contact Person Name
- Angelo Guido Corsico
- Contact Person Email
- corsico@unipv.it
- Site Name
- Azienda Ospedaliero Universitaria Delle Marche
- Department Name
- Respiratory Medicine Unit
- Principal Investigator Name
- Martina Bonifazi
- Principal Investigator Email
- martina.bonifazi@ospedaliriuniti.marche.it
- Contact Person Name
- Martina Bonifazi
- Contact Person Email
- martina.bonifazi@ospedaliriuniti.marche.it
- Site Name
- Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
- Department Name
- SC Pneumologia e Fibrosi Cistica
- Principal Investigator Name
- Francesco Bruno Arturo Blasi
- Principal Investigator Email
- francesco.blasi@policlinico.mi.it
- Contact Person Name
- Francesco Bruno Arturo Blasi
- Contact Person Email
- francesco.blasi@policlinico.mi.it
- Site Name
- Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone (duplicate entry consolidation if present)
- Department Name
- UOC di Pneumologia
Belgium
- Earliest CTIS Part Ii Submission Date
- 20-10-2025
- Latest Decision Or Authorization Date
- 03-11-2025
- Processing Time Days
- 14
- Number Of Sites
- 4
- Number Of Participants
- 7
Sites
- Site Name
- Universitair Ziekenhuis Gent
- Department Name
- Respiratory Medicine
- Principal Investigator Name
- Eva Van Braeckel
- Principal Investigator Email
- eva.vanbraeckel@ugent.be
- Contact Person Name
- Eva Van Braeckel
- Contact Person Email
- eva.vanbraeckel@ugent.be
- Site Name
- Vitaz
- Department Name
- Pulmonary and Infectious Diseases
- Principal Investigator Name
- Pieter Goeminne
- Principal Investigator Email
- pieter.goeminne@vitaz.be
- Contact Person Name
- Pieter Goeminne
- Contact Person Email
- pieter.goeminne@vitaz.be
- Site Name
- UZ Leuven
- Department Name
- Pulmonology
- Principal Investigator Name
- Natalie Lorent
- Principal Investigator Email
- natalie.lorent@uzleuven.be
- Contact Person Name
- Natalie Lorent
- Contact Person Email
- natalie.lorent@uzleuven.be
- Site Name
- Centre hospitalier universitaire de Liege
- Department Name
- Pneumologie - Allergologie
- Principal Investigator Name
- Doriane Calmés
- Principal Investigator Email
- dcalmes@chuliege.be
- Contact Person Name
- Doriane Calmés
- Contact Person Email
- dcalmes@chuliege.be
Greece
- Earliest CTIS Part Ii Submission Date
- 21-10-2025
- Latest Decision Or Authorization Date
- 13-11-2025
- Processing Time Days
- 23
- Number Of Sites
- 8
- Number Of Participants
- 20
Sites
- Site Name
- University General Hospital Attikon General Hospital Of West Attica H Agia Varvara
- Department Name
- 2nd Department of Respiratory Medicine
- Principal Investigator Name
- Stylianos Loukidis
- Principal Investigator Email
- loukstel@med.uoa.gr
- Contact Person Name
- Stylianos Loukidis
- Contact Person Email
- loukstel@med.uoa.gr
- Site Name
- General University Hospital Of Patras
- Department Name
- Department of Respiratory Medicine
- Principal Investigator Name
- Argyrios Tzouvelekis
- Principal Investigator Email
- argyris.tzouvelekis@gmail.com
- Contact Person Name
- Argyrios Tzouvelekis
- Contact Person Email
- argyris.tzouvelekis@gmail.com
- Site Name
- University General Hospital Of Ioannina
- Department Name
- Respiratory Clinic
- Principal Investigator Name
- Konstantinos Kostikas
- Principal Investigator Email
- ktkostikas@gmail.com
- Contact Person Name
- Konstantinos Kostikas
- Contact Person Email
- ktkostikas@gmail.com
- Site Name
- General University Hospital Of Larissa
- Department Name
- Pulmonary Clinic
- Principal Investigator Name
- Zoe Daniil
- Principal Investigator Email
- zdaniil@med.uth.gr
- Contact Person Name
- Zoe Daniil
- Contact Person Email
- zdaniil@med.uth.gr
- Site Name
- Geniko Nosokomeio Thessalonikis George Papanikolaou
- Department Name
- Respiratory Department
- Principal Investigator Name
- Konstantinos Porpodis
- Principal Investigator Email
- kporpodis@yahoo.gr
- Contact Person Name
- Konstantinos Porpodis
- Contact Person Email
- kporpodis@yahoo.gr
- Site Name
- Sismanogleio General Hospital
- Department Name
- Adult CF Unit
- Principal Investigator Name
- Filia Diamantea
- Principal Investigator Email
- Fdiamantea@gmail.com
- Contact Person Name
- Filia Diamantea
- Contact Person Email
- Fdiamantea@gmail.com
- Site Name
- Thoracic General Hospital Of Athens I Sotiria
- Department Name
- 1st University Department of Respiratory Medicine
- Principal Investigator Name
- Petros Bakakos
- Principal Investigator Email
- petros44@hotmail.com
- Contact Person Name
- Petros Bakakos
- Contact Person Email
- petros44@hotmail.com
- Site Name
- Athens Medical Center S.A.
- Department Name
- Respiratory Department
- Principal Investigator Name
- Dimosthenis Papapetrou
- Principal Investigator Email
- dimospapapetroudsa@hotmail.com
- Contact Person Name
- Dimosthenis Papapetrou
- Contact Person Email
- dimospapapetroudsa@hotmail.com
Germany
- Earliest CTIS Part Ii Submission Date
- 15-10-2025
- Latest Decision Or Authorization Date
- 03-11-2025
- Processing Time Days
- 19
- Number Of Sites
- 7
- Number Of Participants
- 17
Sites
- Site Name
- IKF Pneumologie GmbH & Co. KG
- Principal Investigator Name
- Andreas Eich
- Principal Investigator Email
- eich@ikf-pneumologie.de
- Contact Person Name
- Andreas Eich
- Contact Person Email
- eich@ikf-pneumologie.de
- Site Name
- Klinikum Konstanz GmbH
- Department Name
- Studienzentrums der Inneren Medizin
- Principal Investigator Name
- Stephan Walrerspacher
- Principal Investigator Email
- stephan.walterspacher@glkn.de
- Contact Person Name
- Stephan Walrerspacher
- Contact Person Email
- stephan.walterspacher@glkn.de
- Site Name
- Lungenheilkunde München-Pasing
- Principal Investigator Name
- Rainald Fischer
- Principal Investigator Email
- rainald.fischer@gmail.com
- Contact Person Name
- Rainald Fischer
- Contact Person Email
- rainald.fischer@gmail.com
- Site Name
- Ruhrlandklinik Westdeutsches Lungenzentrum Am Universitaetsklinikum Essen gGmbH
- Department Name
- Klinik für Pneumologie
- Principal Investigator Name
- Sivagurunathan Sutharsan
- Principal Investigator Email
- sivagurunathan.sutharsan@rlk.uk-essen.de
- Contact Person Name
- Sivagurunathan Sutharsan
- Contact Person Email
- sivagurunathan.sutharsan@rlk.uk-essen.de
- Site Name
- LMU Klinikum Muenchen AöR
- Department Name
- Medizinische Klinik und Poliklinik V
- Principal Investigator Name
- Pontus Mertsch
- Principal Investigator Email
- Pontus.Mertsch@med.uni-muenchen.de
- Contact Person Name
- Pontus Mertsch
- Contact Person Email
- Pontus.Mertsch@med.uni-muenchen.de
- Site Name
- Medizinische Hochschule Hannover
- Department Name
- Klinik für Pädiatrische Pneumologie, Allergologie und Neonatologie
- Principal Investigator Name
- Felix Ringshausen
- Principal Investigator Email
- Ringshausen.Felix@mh-hannover.de
- Contact Person Name
- Felix Ringshausen
- Contact Person Email
- Ringshausen.Felix@mh-hannover.de
- Site Name
- Pneumologicum Halle
- Principal Investigator Name
- Peter-Uwe Haase
- Principal Investigator Email
- mail@pneumologicum-halle.de
- Contact Person Name
- Peter-Uwe Haase
- Contact Person Email
- mail@pneumologicum-halle.de
Spain
- Earliest CTIS Part Ii Submission Date
- 20-10-2025
- Latest Decision Or Authorization Date
- 04-11-2025
- Processing Time Days
- 15
- Number Of Sites
- 8
- Number Of Participants
- 15
Sites
- Site Name
- Hospital De Merida
- Department Name
- Neumology
- Principal Investigator Name
- Antonio Manuel Perez Fernandez
- Principal Investigator Email
- ampf7395@gmail.com
- Contact Person Name
- Antonio Manuel Perez Fernandez
- Contact Person Email
- ampf7395@gmail.com
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- Neumology
- Principal Investigator Name
- Oriol Sibila Vidal
- Principal Investigator Email
- osibila@clinic.cat
- Contact Person Name
- Oriol Sibila Vidal
- Contact Person Email
- osibila@clinic.cat
- Site Name
- Hospital Del Mar
- Department Name
- Neumology
- Principal Investigator Name
- Esther Barreiro Portela
- Principal Investigator Email
- ebarreiro@researchmar.net
- Contact Person Name
- Esther Barreiro Portela
- Contact Person Email
- ebarreiro@researchmar.net
- Site Name
- Hospital Universitario Fundacion Jimenez Diaz
- Department Name
- Neumology
- Principal Investigator Name
- Carolina Gotera Rivera
- Principal Investigator Email
- carolina.gotera@fjd.es
- Contact Person Name
- Carolina Gotera Rivera
- Contact Person Email
- carolina.gotera@fjd.es
- Site Name
- Hospital Vithas Xanit Internacional
- Department Name
- Neumology
- Principal Investigator Name
- Gustavo de Luiz Martinez
- Principal Investigator Email
- gdeluizmartinez@yahoo.es
- Contact Person Name
- Gustavo de Luiz Martinez
- Contact Person Email
- gdeluizmartinez@yahoo.es
- Site Name
- Hospital Universitario Y Politecnico La Fe
- Department Name
- Neumology
- Principal Investigator Name
- Raul Mendez Ocana
- Principal Investigator Email
- mendez_rau@gva.es
- Contact Person Name
- Raul Mendez Ocana
- Contact Person Email
- mendez_rau@gva.es
- Site Name
- Hospital Universitario La Paz
- Department Name
- Neumology
- Principal Investigator Name
- Ester Zamarron de Lucas
- Principal Investigator Email
- esterzamarron@gmail.com
- Contact Person Name
- Ester Zamarron de Lucas
- Contact Person Email
- esterzamarron@gmail.com
- Site Name
- Hospital Universitario Dr Peset Aleixandre
- Department Name
- Neumology
- Principal Investigator Name
- Ruben Lera Alvarez
- Principal Investigator Email
- ruben_lera@hotmail.com
- Contact Person Name
- Ruben Lera Alvarez
- Contact Person Email
- ruben_lera@hotmail.com
Denmark
- Earliest CTIS Part Ii Submission Date
- 20-10-2025
- Latest Decision Or Authorization Date
- 03-11-2025
- Processing Time Days
- 14
- Number Of Sites
- 4
- Number Of Participants
- 18
Sites
- Site Name
- Region Sjaelland
- Department Name
- Dept of Internal medicine
- Principal Investigator Name
- Christian Meyer
- Principal Investigator Email
- cnm@regionsjaelland.dk
- Contact Person Name
- Christian Meyer
- Contact Person Email
- cnm@regionsjaelland.dk
- Site Name
- Region Hovedstaden
- Department Name
- Respiratory Medicine
- Principal Investigator Name
- Charlotte Suppli Ulrik
- Principal Investigator Email
- charlotte.suppli.ulrik@regionh.dk
- Contact Person Name
- Charlotte Suppli Ulrik
- Contact Person Email
- charlotte.suppli.ulrik@regionh.dk
- Site Name
- Aalborg University Hospital
- Department Name
- Department of Respiratory Diseases
- Principal Investigator Name
- Ulla Møller Weinreich
- Principal Investigator Email
- ulw@rn.dk
- Contact Person Name
- Ulla Møller Weinreich
- Contact Person Email
- ulw@rn.dk
- Site Name
- Odense University Hospital
- Department Name
- Department of Respiratory Medicine
- Principal Investigator Name
- Sofie Lock Johansson
- Principal Investigator Email
- Sofie.johansson@rsyd.dk
- Contact Person Name
- Sofie Lock Johansson
- Contact Person Email
- Sofie.johansson@rsyd.dk
France
- Earliest CTIS Part Ii Submission Date
- 16-10-2025
- Latest Decision Or Authorization Date
- 14-11-2025
- Processing Time Days
- 29
- Number Of Sites
- 8
- Number Of Participants
- 14
Sites
- Site Name
- Centre Hospitalier Regional De Marseille
- Department Name
- Pôle Thorax, département de Pneumologie, Allergologie et Cancérologie Unité de Pneumologie aigüe
- Principal Investigator Name
- Marion Gouitaa
- Principal Investigator Email
- marion.gouitaa@ap-hm.fr
- Contact Person Name
- Marion Gouitaa
- Contact Person Email
- marion.gouitaa@ap-hm.fr
- Site Name
- Centre Hospitalier Universitaire De Bordeaux
- Department Name
- Pneumologie
- Principal Investigator Name
- Julie Macey
- Principal Investigator Email
- julie.macey@chu-bordeaux.fr
- Contact Person Name
- Julie Macey
- Contact Person Email
- julie.macey@chu-bordeaux.fr
- Site Name
- Centre Hospitalier Universitaire De Toulouse
- Department Name
- Pneumologie
- Principal Investigator Name
- Marlene Murris-Espin
- Principal Investigator Email
- murris.m@chu-toulouse.fr
- Contact Person Name
- Marlene Murris-Espin
- Contact Person Email
- murris.m@chu-toulouse.fr
- Site Name
- Centre Hospitalier Universitaire De Montpellier
- Department Name
- Service des maladies respiratoires – Departement de pneumologie
- Principal Investigator Name
- Arnaud Bourdin
- Principal Investigator Email
- a-bourdin@chu-montpellier.fr
- Contact Person Name
- Arnaud Bourdin
- Contact Person Email
- a-bourdin@chu-montpellier.fr
- Site Name
- Centre Hospitalier Intercommunal Creteil
- Department Name
- Pneumologie / UFR Sante Medecine
- Principal Investigator Name
- Bernard Maitre
- Principal Investigator Email
- bernard.maitre@chicreteil.fr
- Contact Person Name
- Bernard Maitre
- Contact Person Email
- bernard.maitre@chicreteil.fr
- Site Name
- Les Hopitaux Universitaires De Strasbourg
- Department Name
- Pneumologie
- Principal Investigator Name
- Loic Kassegne
- Principal Investigator Email
- loic.kassegne@chru-strasbourg.fr
- Contact Person Name
- Loic Kassegne
- Contact Person Email
- loic.kassegne@chru-strasbourg.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Pneumologie
- Principal Investigator Name
- Pierre-Regis Burgel
- Principal Investigator Email
- pierre-regis.burgel@aphp.fr
- Contact Person Name
- Pierre-Regis Burgel
- Contact Person Email
- pierre-regis.burgel@aphp.fr
- Site Name
- Centre Hospitalier Regional Et Universitaire De Brest
- Department Name
- Pneumologie
- Principal Investigator Name
- Raphael Le Mao
- Principal Investigator Email
- raphael.lemao@chu-brest.fr
- Contact Person Name
- Raphael Le Mao
- Contact Person Email
- raphael.lemao@chu-brest.fr
Netherlands
- Earliest CTIS Part Ii Submission Date
- 27-10-2025
- Latest Decision Or Authorization Date
- 05-11-2025
- Processing Time Days
- 9
- Number Of Sites
- 3
- Number Of Participants
- 6
Sites
- Site Name
- Gelre Hospitals
- Department Name
- Pulmonary Research Department
- Principal Investigator Name
- Martijn Goosens
- Principal Investigator Email
- goosens.research@gelre.nl
- Contact Person Name
- Martijn Goosens
- Contact Person Email
- goosens.research@gelre.nl
- Site Name
- Amsterdam UMC Stichting
- Department Name
- Pulmonary Department
- Principal Investigator Name
- Josje Altenburg
- Principal Investigator Email
- j.altenburg@amsterdamumc.nl
- Contact Person Name
- Josje Altenburg
- Contact Person Email
- j.altenburg@amsterdamumc.nl
- Site Name
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Department Name
- Pulmonary Department
- Principal Investigator Name
- Menno van der Eerden
- Principal Investigator Email
- m.vandereerden@erasmusmc.nl
- Contact Person Name
- Menno van der Eerden
- Contact Person Email
- m.vandereerden@erasmusmc.nl
Sponsor
Primary sponsor
- Full Name
- AstraZeneca AB
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Sweden
Investigational products
- Investigational Product Name
- AZD0292
- Active Substance
- AZD0292
- Modality
- Monoclonal antibody
- Routes Of Administration
- SOLUTION FOR INFUSION
- Route
- SOLUTION FOR INFUSION
- Investigational Product Name
- Placebo for AZD0292
Related trials
Other published trials that may interest you.
- phospholipid fraction, bovine lung for Idiopathic pulmonary fibrosis
- Allogeneic bone marrow-derived mesenchymal adult stromal cells, ex-vivo expanded for Chronic lung allograft dysfunction (CLAD) | Bronchiolitis obliterans syndrome (BOS) in lung transplant recipients
- IVX-121; HUMAN METAPNEUMOVIRUS, VIRUS-LIKE PROTEIN for Respiratory syncytial virus infection | Human metapneumovirus infection
- Lyophilized bacterial lysates of: Haemophilus influenzae, Streptococcus (Diplococcus) pneumoniae, Klebsiella pneumoniae and ozaenae, Staphylococcus aureus, Streptococcus pyogenes and viridans, Moraxella (Branhamella/Neisseria) catarrhalis (OM-85) for Respiratory tract infections with wheezing lower respiratory illness
- Roginolisib for Advanced non-squamous non-small cell lung cancer