Clinical trial • Phase II • Respiratory
LUNSEKIMIG for Asthma
Phase II trial of LUNSEKIMIG for Asthma. Randomised, matching placebo for test (placebo comparator); no dose or schedule specified-controlled.
Overview
- Trial Therapeutic Area
- Respiratory
- Trial Disease
- Asthma
- Trial Stage
- Phase II
- Drug Modality
- Other antibody
Key dates
- Initial CTIS Submission Date
- 15-11-2024
- First CTIS Authorization Date
- 18-03-2025
Trial design
Randomised, matching placebo for test (placebo comparator); no dose or schedule specified-controlled Phase II trial in Belgium, Denmark, Hungary and others.
- Randomised
- Yes
- Comparator
- Matching Placebo for Test (placebo comparator); no dose or schedule specified
- Target Sample Size
- 1795
Eligibility
Recruits 1795 adults.
Inclusion criteria
- {"criterion_text":"- Physician-diagnosed mild-to-moderate asthma for more than 12 months based on GINA guidelines.\n- At least 1 asthma exacerbation in the year prior to Screening (Visit 1)\n- Pre-BD FEV1 of equal or more than 40% of predicted normal (by Global Lung Function Initiative [GLI] standards) at Screening (Visit 1)."}
Exclusion criteria
- {"criterion_text":"- Other severe lung diseases (eg, chronic obstructive pulmonary disease [COPD],bronchiectasis, idiopathic pulmonary fibrosis, etc) which may impair lung function.\n- Participants who experience a deterioration of asthma that results in emergency treatment or hospitalization, or treatment with systemic steroids within 1 month prior to the Screening (Visit 1) (counting from the date of completion of treatment for asthma exacerbation).\n- Participants who have experienced an upper or lower respiratory tract infection within the 4 weeks prior to Screening (Visit 1).\n- Known history of, or suspected, significant current immunosuppression, including history of invasive opportunistic or helminthic infections despite infection resolution or otherwise recurrent infections of abnormal frequency or prolonged duration.\n- Evidence of any infection requiring systemic anti-infective treatment within 2 weeks before Screening (Visit 1) or during the screening period. Significant viral infections within 2 weeks before Screening (Visit 1) or during the screening period even if the participant has not received systemic antiviral treatment (eg, influenza receiving only symptomatic treatment).\n- Participants with active tuberculosis (TB), latent TB, a history of incompletely treated TB, suspected extrapulmonary TB infection, or who are at high risk of contracting TB (such as close contact with individuals with active TB), or received Bacillus Calmette- Guérin (BCG)-vaccination within 12 weeks prior to Screening (Visit 1).\n- Severe concomitant illness that would in the Investigator's opinion inhibit the participant's participation in the study, including for example, but not limited to, hypertension, renal disease, neurological conditions, heart failure, and pulmonary disease."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Annualized rate of asthma exacerbation events","definition_or_measurement_approach":""}
Secondary endpoints
- {"endpoint_text":"- Change from baseline in pre-bronchodilator (BD) forced expiratory volume in 1 second (FEV1)","definition_or_measurement_approach":""}
- {"endpoint_text":"- Change from baseline in Asthma Control Questionnaire-5 (ACQ-5) score","definition_or_measurement_approach":""}
- {"endpoint_text":"- Change from baseline in FeNO level","definition_or_measurement_approach":""}
- {"endpoint_text":"- Annualized rate of loss of asthma control events (LOAC) events","definition_or_measurement_approach":""}
- {"endpoint_text":"- Annualized rate of asthma exacerbations requiring hospitalization or emergency room or urgent care visit","definition_or_measurement_approach":""}
- {"endpoint_text":"- Total systemic corticosteroid dose exposure","definition_or_measurement_approach":""}
- {"endpoint_text":"- Change from baseline in Asthma Quality of Life Questionnaire Standardized (AQLQ{S}) scores","definition_or_measurement_approach":""}
- {"endpoint_text":"- Change from baseline in the Asthma Daytime Symptom Diary (ADSD) daily morning and evening score","definition_or_measurement_approach":""}
- {"endpoint_text":"- Serum lunsekimig concentrations","definition_or_measurement_approach":""}
- {"endpoint_text":"- Incidence and titer of anti-drug antibodies (ADA) against lunsekimig","definition_or_measurement_approach":""}
- {"endpoint_text":"- Incidence of participants with treatment- emergent adverse events (TEAEs), including local reactions, adverse events of special interests (AESIs), serious adverse events (SAEs)","definition_or_measurement_approach":""}
Recruitment
- Digital Remote Recruitment
- Yes
- Planned Sample Size
- 1795
- Recruitment Window Months
- 30
- Consent Approach
- Informed consent is documented via subject information and informed consent form (L1 redacted SIS-ICF) and patient ICF/prescreening ICF documents provided for the study. ICF and subject information materials are available in multiple languages across countries (examples in the document list: English, French, Dutch, Danish, Hungarian, Italian, Polish, Spanish, Swedish, German, Romanian). Consent is obtained from adult participants using these ICF materials (prescreening and main ICF documents provided).
Methods
- Flyers, posters and brochures distributed at sites and in clinics (patient-facing printed materials).
- Doctor-to-patient letters and doctor-to-doctor referral letters (GP/clinician referral channels).
- Prescreening and self-assessment materials (online/paper prescreening questionnaires).
- Digital marketing content and online landing pages (digital recruitment including Trialbee campaign materials and landing pages).
- Toolkit modules and on-screen texts for educational recruitment content.
- Region- and country-specific invitations and materials (examples: Region Stockholm primary care invitation; country-specific K1/K2 recruitment materials for BE, DK, FR, DE, ES, IT, HU, PL, RO, SV).
Geography
- Total Number Of Sites
- 65
- Total Number Of Participants
- 673
Belgium
- Earliest CTIS Part Ii Submission Date
- 17-02-2025
- Latest Decision Or Authorization Date
- 10-04-2026
- Processing Time Days
- 417
- Number Of Sites
- 3
- Number Of Participants
- 34
Sites
- Site Name
- Emmaues
- Department Name
- AZ Sint Maarten( #1)
- Principal Investigator Name
- Muriel Lins
- Principal Investigator Email
- muriel.lins@emmaus.be
- Contact Person Name
- Muriel Lins
- Contact Person Email
- muriel.lins@emmaus.be
- Site Name
- Centre Hospitalier Universitaire De Liege
- Department Name
- CHU de Liège( #1)
- Principal Investigator Name
- Renaud Louis
- Principal Investigator Email
- r.louis@chu.ulg.ac.be
- Contact Person Name
- Renaud Louis
- Contact Person Email
- r.louis@chu.ulg.ac.be
- Site Name
- Universitair Ziekenhuis Gent
- Department Name
- Universitair Ziekenhuis Gent
- Principal Investigator Name
- Guy Brusselle
- Principal Investigator Email
- guy.brusselle@uzgent.be
- Contact Person Name
- Guy Brusselle
- Contact Person Email
- guy.brusselle@uzgent.be
Denmark
- Earliest CTIS Part Ii Submission Date
- 11-03-2025
- Latest Decision Or Authorization Date
- 10-04-2026
- Processing Time Days
- 395
- Number Of Sites
- 2
- Number Of Participants
- 17
Sites
- Site Name
- Hvidovre Hospital
- Department Name
- Lungemedicinsk og Endokrinologisk Afdeling
- Principal Investigator Name
- Charlotte Suppli Ulrik
- Principal Investigator Email
- csulrik@dadlnet.dk
- Contact Person Name
- Charlotte Suppli Ulrik
- Contact Person Email
- csulrik@dadlnet.dk
- Site Name
- Lillebaelt Hospital
- Department Name
- Lungemedicinsk Forskningsenhed
- Principal Investigator Name
- Ole Hilberg
- Principal Investigator Email
- ole.hilberg@rsyd.dk
- Contact Person Name
- Ole Hilberg
- Contact Person Email
- ole.hilberg@rsyd.dk
Hungary
- Earliest CTIS Part Ii Submission Date
- 29-01-2025
- Latest Decision Or Authorization Date
- 13-04-2026
- Processing Time Days
- 439
- Number Of Sites
- 6
- Number Of Participants
- 69
Sites
- Site Name
- Infer-Med Kft.
- Department Name
- Infer -Med Kft.
- Principal Investigator Name
- Marta Papp
- Principal Investigator Email
- drpappm@gmail.com
- Contact Person Name
- Marta Papp
- Contact Person Email
- drpappm@gmail.com
- Site Name
- Omnimodus Elixir Kft.
- Department Name
- Omnimodus Elixír Szolgáltató Kft.
- Principal Investigator Name
- Erika Ivett Unger
- Principal Investigator Email
- ungerstudy@gmail.com
- Contact Person Name
- Erika Ivett Unger
- Contact Person Email
- ungerstudy@gmail.com
- Site Name
- Puspokladanyi Egeszsegugyi Szolgaltato Nonprofit Kft.
- Department Name
- Püspökladányi Egészségügyi Szolgáltató Nonprofit Kft.( #1)
- Principal Investigator Name
- Nelli Kosztyu
- Principal Investigator Email
- nellypharmanex@gmail.com
- Contact Person Name
- Nelli Kosztyu
- Contact Person Email
- nellypharmanex@gmail.com
- Site Name
- Erzsebet Gondozohaz Kft.
- Department Name
- Erzsébet Gondozóház Kft.( #2)
- Principal Investigator Name
- Janos Mucsi
- Principal Investigator Email
- mucsitrial@gmail.com
- Contact Person Name
- Janos Mucsi
- Contact Person Email
- mucsitrial@gmail.com
- Site Name
- Crodoctor Kft.
- Department Name
- Crodoctor Kft
- Principal Investigator Name
- Edina Kurucz
- Principal Investigator Email
- drkuruczedina@gmail.com
- Contact Person Name
- Edina Kurucz
- Contact Person Email
- drkuruczedina@gmail.com
- Site Name
- University Of Debrecen
- Department Name
- Tüdőgyógyászati Klinika
- Principal Investigator Name
- Ildiko Horvath
- Principal Investigator Email
- horvath.ildiko@med.unideb.hu
- Contact Person Name
- Ildiko Horvath
- Contact Person Email
- horvath.ildiko@med.unideb.hu
France
- Earliest CTIS Part Ii Submission Date
- 13-01-2025
- Latest Decision Or Authorization Date
- 10-04-2026
- Processing Time Days
- 452
- Number Of Sites
- 7
- Number Of Participants
- 46
Sites
- Site Name
- Clinique De L'Europe
- Department Name
- Clinique de l'Europe (#1)
- Principal Investigator Name
- Youcef DOUADI
- Principal Investigator Email
- y.douadi@ch-stquentin.fr
- Contact Person Name
- Youcef DOUADI
- Contact Person Email
- y.douadi@ch-stquentin.fr
- Site Name
- Hospices Civils De Lyon
- Department Name
- Service de Pneumologie
- Principal Investigator Name
- Gilles Devouassoux
- Principal Investigator Email
- gilles.devouassoux@chu-lyon.fr
- Contact Person Name
- Gilles Devouassoux
- Contact Person Email
- gilles.devouassoux@chu-lyon.fr
- Site Name
- Centre Hospitalier Universitaire De Toulouse
- Department Name
- Département de pneumologie- Pôle voies respiratoires
- Principal Investigator Name
- Laurent GUILLEMINAULT
- Principal Investigator Email
- guilleminault.l@chu-toulouse.fr
- Contact Person Name
- Laurent GUILLEMINAULT
- Contact Person Email
- guilleminault.l@chu-toulouse.fr
- Site Name
- Les Hopitaux Universitaires De Strasbourg
- Department Name
- Asthme et Allergologie
- Principal Investigator Name
- Naji Khayath
- Principal Investigator Email
- naji.khayath@chru-strasbourg.fr
- Contact Person Name
- Naji Khayath
- Contact Person Email
- naji.khayath@chru-strasbourg.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Service de Pneumologie et de Transplantation Pulmonaire
- Principal Investigator Name
- Camille Taillé
- Principal Investigator Email
- camille.taille@bch.aphp.fr
- Contact Person Name
- Camille Taillé
- Contact Person Email
- camille.taille@bch.aphp.fr
- Site Name
- Centre Hospitalier Universitaire De Montpellier
- Department Name
- Service des Maladies Respiratoires
- Principal Investigator Name
- Arnaud BOURDIN
- Principal Investigator Email
- arnaud01009157@gmail.com
- Contact Person Name
- Arnaud BOURDIN
- Contact Person Email
- arnaud01009157@gmail.com
- Site Name
- Centre Hospitalier Universitaire De Bordeaux
- Department Name
- Centre d'Investigation Clinique Plurithématique, unité pneumologie,
- Principal Investigator Name
- Pierre-Olivier Girodet
- Principal Investigator Email
- pierre-olivier.girodet@u-bordeaux.fr
- Contact Person Name
- Pierre-Olivier Girodet
- Contact Person Email
- pierre-olivier.girodet@u-bordeaux.fr
Italy
- Earliest CTIS Part Ii Submission Date
- 11-03-2025
- Latest Decision Or Authorization Date
- 15-04-2026
- Processing Time Days
- 400
- Number Of Sites
- 12
- Number Of Participants
- 114
Sites
- Site Name
- IRCCS Ospedale Policlinico San Martino
- Department Name
- IRCCS Ospedale Policlinico San Martino
- Principal Investigator Name
- Fulvio Braido
- Principal Investigator Email
- fulvio.braido@unige.it
- Contact Person Name
- Fulvio Braido
- Contact Person Email
- fulvio.braido@unige.it
- Site Name
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Department Name
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Principal Investigator Name
- Cristiano Caruso
- Principal Investigator Email
- cristiano.caruso@policlinicogemelli.it
- Contact Person Name
- Cristiano Caruso
- Contact Person Email
- cristiano.caruso@policlinicogemelli.it
- Site Name
- Azienda Ospedaliero Universitaria Delle Marche
- Department Name
- Azienda Ospedaliero Universitaria Delle Marche
- Principal Investigator Name
- Beatrice Maria Bilò
- Principal Investigator Email
- m.b.bilo@staff.univpm.it
- Contact Person Name
- Beatrice Maria Bilò
- Contact Person Email
- m.b.bilo@staff.univpm.it
- Site Name
- Humanitas Mirasole S.p.A.
- Department Name
- Istituto Clinico Humanitas
- Principal Investigator Name
- Giovanni Paoletti
- Principal Investigator Email
- giovanni.paoletti@hunimed.eu
- Contact Person Name
- Giovanni Paoletti
- Contact Person Email
- giovanni.paoletti@hunimed.eu
- Site Name
- Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
- Department Name
- Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
- Principal Investigator Name
- Nicola Scichilone
- Principal Investigator Email
- nicola.scichilone@unipa.it
- Contact Person Name
- Nicola Scichilone
- Contact Person Email
- nicola.scichilone@unipa.it
- Site Name
- Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii
- Department Name
- Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
- Principal Investigator Name
- Fabiano Di Marco
- Principal Investigator Email
- fdimarco@asst-pg23.it
- Contact Person Name
- Fabiano Di Marco
- Contact Person Email
- fdimarco@asst-pg23.it
- Site Name
- Azienda USL IRCCS Di Reggio Emilia
- Department Name
- Azienda USL IRCCS Di Reggio Emilia
- Principal Investigator Name
- Anna Simonazzi
- Principal Investigator Email
- anna.simonazzi@ausl.re.it
- Contact Person Name
- Anna Simonazzi
- Contact Person Email
- anna.simonazzi@ausl.re.it
- Site Name
- Azienda Ospedaliero Universitaria Di Modena
- Department Name
- Azienda Ospedaliero Universitaria di Modena
- Principal Investigator Name
- Bianca Beghé
- Principal Investigator Email
- bianca.beghe@unimore.it
- Contact Person Name
- Bianca Beghé
- Contact Person Email
- bianca.beghe@unimore.it
- Site Name
- University Hospital Of Ferrara
- Department Name
- Ospedale Universitario di Ferrara
- Principal Investigator Name
- Alberto Papi
- Principal Investigator Email
- ppa@unife.it
- Contact Person Name
- Alberto Papi
- Contact Person Email
- ppa@unife.it
- Site Name
- Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
- Department Name
- Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico( #1)
- Principal Investigator Name
- Francesco Bruno Arturo Blasi
- Principal Investigator Email
- francesco.blasi@unimi.it
- Contact Person Name
- Francesco Bruno Arturo Blasi
- Contact Person Email
- francesco.blasi@unimi.it
- Site Name
- Istituti Clinici Scientifici Maugeri S.p.A.
- Department Name
- Istituti Clinici Scientifici Maugeri S.p.A.
- Principal Investigator Name
- Dina Visca
- Principal Investigator Email
- dina.visca@icsmaugeri.it
- Contact Person Name
- Dina Visca
- Contact Person Email
- dina.visca@icsmaugeri.it
- Site Name
- Azienda Ospedaliero-Universitaria Di Cagliari
- Department Name
- Azienda Ospedaliero-Universitaria Di Cagliari
- Principal Investigator Name
- Stefano Del Giacco
- Principal Investigator Email
- delgiac@gmail.com
- Contact Person Name
- Stefano Del Giacco
- Contact Person Email
- delgiac@gmail.com
Romania
- Earliest CTIS Part Ii Submission Date
- 20-02-2025
- Latest Decision Or Authorization Date
- 15-04-2026
- Processing Time Days
- 419
- Number Of Sites
- 2
- Number Of Participants
- 29
Sites
- Site Name
- Arensia Clinics S.R.L.
- Department Name
- Pneumology
- Principal Investigator Name
- Ionela Camelia Nita
- Principal Investigator Email
- camelia.nita@arensia-em.com
- Contact Person Name
- Ionela Camelia Nita
- Contact Person Email
- camelia.nita@arensia-em.com
- Site Name
- Spitalul Clinic Judetean De Urgenta Cluj
- Department Name
- Medical II
- Principal Investigator Name
- Andrei Lesan
- Principal Investigator Email
- andrei.lesan.ext@arensia-em.com
- Contact Person Name
- Andrei Lesan
- Contact Person Email
- andrei.lesan.ext@arensia-em.com
Spain
- Earliest CTIS Part Ii Submission Date
- 18-02-2025
- Latest Decision Or Authorization Date
- 14-04-2026
- Processing Time Days
- 420
- Number Of Sites
- 15
- Number Of Participants
- 120
Sites
- Site Name
- Hospital Universitario La Paz
- Department Name
- Servicio de Neumología
- Principal Investigator Name
- David Romero Ribate
- Principal Investigator Email
- davizrom@hotmail.com
- Contact Person Name
- David Romero Ribate
- Contact Person Email
- davizrom@hotmail.com
- Site Name
- Hospital Germans Trias I Pujol
- Department Name
- Hospital Universitari Germans Trias i Pujol( #1)
- Principal Investigator Name
- Carlos Martinez Rivera
- Principal Investigator Email
- carlosmartinezrivera.cmr@gmail.com
- Contact Person Name
- Carlos Martinez Rivera
- Contact Person Email
- carlosmartinezrivera.cmr@gmail.com
- Site Name
- Hospital Universitario Marques De Valdecilla
- Department Name
- Pneumology
- Principal Investigator Name
- Juan Garcia Rivero
- Principal Investigator Email
- jgarcia@separ.es
- Contact Person Name
- Juan Garcia Rivero
- Contact Person Email
- jgarcia@separ.es
- Site Name
- Hospital General Universitario Gregorio Maranon
- Department Name
- Hospital Gregorio Marañon
- Principal Investigator Name
- Luis Puente Maestu
- Principal Investigator Email
- lpuente@separ.es
- Contact Person Name
- Luis Puente Maestu
- Contact Person Email
- lpuente@separ.es
- Site Name
- Clinica Gaias Santiago
- Principal Investigator Name
- Pedro Penela Penela
- Principal Investigator Email
- pedropenelaensayos@gmail.com
- Contact Person Name
- Pedro Penela Penela
- Contact Person Email
- pedropenelaensayos@gmail.com
- Site Name
- Hospital Universitario Virgen De La Victoria
- Principal Investigator Name
- Jose Luis Velasco Garrido
- Principal Investigator Email
- jlvelascogarrido@hotmail.com
- Contact Person Name
- Jose Luis Velasco Garrido
- Contact Person Email
- jlvelascogarrido@hotmail.com
- Site Name
- Hospital Universitari Vall D Hebron
- Principal Investigator Name
- Christian Eduardo Romero
- Principal Investigator Email
- christian.romero@vhir.org
- Contact Person Name
- Christian Eduardo Romero
- Contact Person Email
- christian.romero@vhir.org
- Site Name
- Pectus Respiratory Health S.L.
- Department Name
- Institut Català de Serveis Mèdics
- Principal Investigator Name
- Juan Roldan Sanchez
- Principal Investigator Email
- juan.roldan@giromedinstitute.com
- Contact Person Name
- Juan Roldan Sanchez
- Contact Person Email
- juan.roldan@giromedinstitute.com
- Site Name
- Futuremeds Spain S.L.
- Department Name
- FutureMeds Spain Madrid
- Principal Investigator Name
- Jesus Fernandez Frances
- Principal Investigator Email
- jesus.fernandez@futuremeds.com
- Contact Person Name
- Jesus Fernandez Frances
- Contact Person Email
- jesus.fernandez@futuremeds.com
- Site Name
- University Hospital Son Espases
- Department Name
- Hospital Universitari Son Espases( #2)
- Principal Investigator Name
- Francisco de Borja Garcia-Cosio Piqueras
- Principal Investigator Email
- borja.cosio@ssib.es
- Contact Person Name
- Francisco de Borja Garcia-Cosio Piqueras
- Contact Person Email
- borja.cosio@ssib.es
- Site Name
- Hospital Vithas Xanit Internacional
- Department Name
- Pneumology
- Principal Investigator Name
- Gustavo Adolfo de Luiz Martinez
- Principal Investigator Email
- neumologix@yahoo.com
- Contact Person Name
- Gustavo Adolfo de Luiz Martinez
- Contact Person Email
- neumologix@yahoo.com
- Site Name
- Hospital Universitario 12 De Octubre
- Principal Investigator Name
- Ismael Garcia-Moguel
- Principal Investigator Email
- ismaelgmoguel@gmail.com
- Contact Person Name
- Ismael Garcia-Moguel
- Contact Person Email
- ismaelgmoguel@gmail.com
- Site Name
- Hospital La Milagrosa S.A.
- Department Name
- Consultas Externas
- Principal Investigator Name
- Walther Ivan Giron Matute
- Principal Investigator Email
- walter_giron2@hotmail.com
- Contact Person Name
- Walther Ivan Giron Matute
- Contact Person Email
- walter_giron2@hotmail.com
- Site Name
- Hospital Universitari Son Espases (additional listed site)
- Principal Investigator Name
- Juan Roldan Sanchez
- Principal Investigator Email
- juan.roldan@giromedinstitute.com
- Contact Person Name
- Juan Roldan Sanchez
- Contact Person Email
- juan.roldan@giromedinstitute.com
- Site Name
- Pectus Respiratoy Health S.L. (BCN)
- Department Name
- Pectus Respiratoy Health S.L. (BCN)
- Principal Investigator Name
- Juan Roldan Sanchez
- Principal Investigator Email
- juan.roldan@giromedinstitute.com
- Contact Person Name
- Juan Roldan Sanchez
- Contact Person Email
- juan.roldan@giromedinstitute.com
Poland
- Earliest CTIS Part Ii Submission Date
- 03-03-2025
- Latest Decision Or Authorization Date
- 15-04-2026
- Processing Time Days
- 408
- Number Of Sites
- 7
- Number Of Participants
- 102
Sites
- Site Name
- EMC Instytut Medyczny S.A.
- Department Name
- "EMC Instytut Medyczny SA PL Certus Szpital Nr 1 PL Certus Ambulatorium"
- Principal Investigator Name
- Grazyna Skarupa-Szablowska
- Principal Investigator Email
- grasza66@interia.pl
- Contact Person Name
- Grazyna Skarupa-Szablowska
- Contact Person Email
- grasza66@interia.pl
- Site Name
- Centrum Medycyny Oddechowej Mroz Sp. j.
- Department Name
- Centrum Medycyny Oddechowej Mróz Spółka Jawna
- Principal Investigator Name
- Robert M Mroz
- Principal Investigator Email
- robmroz@wp.pl
- Contact Person Name
- Robert M Mroz
- Contact Person Email
- robmroz@wp.pl
- Site Name
- Samodzielny Publiczny Zaklad Opieki Zdrowotnej Centralny Szpital Kliniczny Uniwersytetu Medycznego W Lodzi
- Department Name
- SPZOZ, Centralny Szpital Kliniczny Uniwersytetu Medycznego w Łodzi, Klinika Immunologii i Alergii
- Principal Investigator Name
- Aleksandra Wardzynska
- Principal Investigator Email
- aleksandra.wardzynska@umed.lodz.pl
- Contact Person Name
- Aleksandra Wardzynska
- Contact Person Email
- aleksandra.wardzynska@umed.lodz.pl
- Site Name
- Gyncentrum Sp. z o.o.
- Department Name
- Gyncentrum Sp. z o.o.
- Principal Investigator Name
- Marta Frejowska-Reniecka
- Principal Investigator Email
- m.frejowska-reniecka@holsaclinical.com
- Contact Person Name
- Marta Frejowska-Reniecka
- Contact Person Email
- m.frejowska-reniecka@holsaclinical.com
- Site Name
- Ostrowieckie Centrum Medyczne Anna Olech Cudzik Krzysztof Cudzik s.c.
- Department Name
- Ostrowieckie Centrum Medyczne spółka cywilna Anna Olech-Cudzik, Krzysztof Cudzik
- Principal Investigator Name
- Anna Olech-Cudzik
- Principal Investigator Email
- annacudzik@cudmed.pl
- Contact Person Name
- Anna Olech-Cudzik
- Contact Person Email
- annacudzik@cudmed.pl
- Site Name
- Specjalistyczny Niepubliczny Zaklad Opieki Zdrowotnej Alergologia Plus Osrodek Diagnostyki I Terapii Uczulen
- Department Name
- Specjalistyczny Niepubliczny Zaklad Opieki Zdrowotnej Alergologia Plus Osrodek Diagnostyki I Terapi
- Principal Investigator Name
- Michal Springer
- Principal Investigator Email
- michal.springer.pl@gmail.com
- Contact Person Name
- Michal Springer
- Contact Person Email
- michal.springer.pl@gmail.com
- Site Name
- Wojewodzki Szpital Specjalistyczny Im. Sw. Rafala W Czerwonej Gorze
- Department Name
- Wojewodzki Szpital Specjalistyczny Im. Św. Rafała w Czerwonej Górze
- Principal Investigator Name
- Piotr Łacwik
- Principal Investigator Email
- lacwik@gmail.com
- Contact Person Name
- Piotr Łacwik
- Contact Person Email
- lacwik@gmail.com
Sweden
- Earliest CTIS Part Ii Submission Date
- 26-11-2024
- Latest Decision Or Authorization Date
- 08-05-2026
- Processing Time Days
- 528
- Number Of Sites
- 3
- Number Of Participants
- 17
Sites
- Site Name
- Sahlgrenska University Hospital-Vaestra Goetalandsregionen
- Department Name
- Gothia Forum, Clinical Trial Center
- Principal Investigator Name
- David Sellden
- Principal Investigator Email
- david.sellden@vgregion.se
- Contact Person Name
- David Sellden
- Contact Person Email
- david.sellden@vgregion.se
- Site Name
- Region Skane Skanes Universitetssjukhus
- Department Name
- Lung- och allergiforskning
- Principal Investigator Name
- Jens Christian Richter
- Principal Investigator Email
- jens.richter@skane.se
- Contact Person Name
- Jens Christian Richter
- Contact Person Email
- jens.richter@skane.se
- Site Name
- Karolinska University Hospital
- Department Name
- Lungforskning Solna
- Principal Investigator Name
- Apostolos Bossios
- Principal Investigator Email
- apostolos.bossios@ki.se
- Contact Person Name
- Apostolos Bossios
- Contact Person Email
- apostolos.bossios@ki.se
Sponsor
Primary sponsor
- Full Name
- Sanofi-Aventis Recherche & Developpement
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- France
Contract research organisations
- Name
- Pharmaceutical Product Development LLC
- Responsibilities
- code: 4
- Name
- Labcorp Early Development Laboratories Inc.
- Responsibilities
- code: 4
- Name
- Charles River Laboratories Montreal ULC
- Responsibilities
- code: 4
- Name
- Discovery Life Sciences LLC
- Responsibilities
- code: 4
- Name
- Nuvisan GmbH
- Responsibilities
- code: 4
- Name
- Rules Based Medicine Inc.
- Responsibilities
- code: 4
Third parties
- {"country":"United Kingdom","full_name":"The Doctors Laboratory Limited","duties_or_roles":"code: 4","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"South Africa","full_name":"Farmovs (Pty) Ltd","duties_or_roles":"code: 4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Pharmaceutical Product Development LLC","duties_or_roles":"code: 4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"code: 15; value: eCOA","organisation_type":"Pharmaceutical company"}
- {"country":"Hungary","full_name":"PetMobile Kft.","duties_or_roles":"code: 14","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Germany","full_name":"eResearchTechnology GmbH","duties_or_roles":"code: 7","organisation_type":"Pharmaceutical company"}
- {"country":"Hungary","full_name":"European Pharma Hub Kft.","duties_or_roles":"code: 14","organisation_type":"Pharmaceutical company"}
- {"country":"France","full_name":"Inato","duties_or_roles":"code: 2","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Labcorp Early Development Laboratories Inc.","duties_or_roles":"code: 4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Discovery Life Sciences LLC","duties_or_roles":"code: 4","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"Italy","full_name":"Depo-pack S.r.l.","duties_or_roles":"code: 14","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Rules Based Medicine Inc.","duties_or_roles":"code: 4","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"Canada","full_name":"Charles River Laboratories Montreal ULC","duties_or_roles":"code: 4","organisation_type":"Pharmaceutical company"}
- {"country":"Romania","full_name":"Arensia Exploratory Medicine S.R.L.","duties_or_roles":"code: 15; value: Clinical Site Service Provider","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"code: 3","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"ESMS Global Limited","duties_or_roles":"code: 15; value: Centralized 24-Hour Emergency System: eSMS","organisation_type":"Pharmaceutical company"}
- {"country":"Italy","full_name":"Depo-pack S.r.l.","duties_or_roles":"code: 14","organisation_type":"Pharmaceutical company"}
- {"country":"Germany","full_name":"Nuvisan GmbH","duties_or_roles":"code: 4","organisation_type":"Pharmaceutical company"}
- {"country":"Canada","full_name":"Charles River Laboratories Montreal ULC","duties_or_roles":"code: 4","organisation_type":"Pharmaceutical company"}
- {"country":"Germany","full_name":"Arensia Exploratory Medicine GmbH","duties_or_roles":"code: 15; value: Clinical Site Service Provider - Project Management","organisation_type":"Laboratory/Research/Testing facility"}
Investigational products
- Investigational Product Name
- SAR443765 / LUNSEKIMIG
- Active Substance
- LUNSEKIMIG
- Modality
- Other antibody
- Routes Of Administration
- SUBCUTANEOUS INJECTION
- Route
- SUBCUTANEOUS INJECTION
- Investigational Product Name
- Matching Placebo for Test
- Modality
- Other
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