Clinical trial • Respiratory
ITEPEKIMAB for Chronic obstructive pulmonary disease
Clinical trial of ITEPEKIMAB for Chronic obstructive pulmonary disease.
Overview
- Trial Therapeutic Area
- Respiratory
- Trial Disease
- Chronic obstructive pulmonary disease
- Drug Modality
- Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 08-01-2024
- First CTIS Authorization Date
- 29-04-2024
Trial design
Randomised, matched placebo for test product (placebo) matched to itepekimab; dose and schedule not specified-controlled trial in Bulgaria, Denmark, Estonia and others.
- Randomised
- Yes
- Comparator
- Matched Placebo for test product (placebo) matched to itepekimab; dose and schedule not specified
- Target Sample Size
- 475
- Trial Duration For Participant
- 364
Eligibility
Recruits 475 adults.
Inclusion criteria
- {"criterion_text":"- Patients with COPD who completed the treatment period in a previous itepekimab COPD Phase 3 clinical study (ie, EFC16750 or EFC16819) and for which an end-of-treatment (EOT) visit occurred no later than 3 days before the enrolment visit of this study"}
Exclusion criteria
- {"criterion_text":"- Diagnosis of a malignancy during parent study, except a squamous or basal cell carcinoma of the skin"}
- {"criterion_text":"- Any opportunistic infection during the parent study, such as tuberculosis (TB) or other infections whose nature or course may suggest an immunocompromised status"}
- {"criterion_text":"- Anaphylactic reactions or systemic allergic reactions that are related to IMP and require treatment during the parent study"}
- {"criterion_text":"- Any situation that led to a permanent premature IMP discontinuation in parent trials"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Incidence of treatment‑emergent AEs, AESIs, SAEs, and AEs leading to permanent treatment discontinuation","definition_or_measurement_approach":""}
Secondary endpoints
- {"endpoint_text":"- Functional itepekimab concentrations in serum","definition_or_measurement_approach":""}
- {"endpoint_text":"- Incidence of treatment emergent (TE) anti-drug antibody responses","definition_or_measurement_approach":""}
- {"endpoint_text":"- Annualized rate of moderate to severe acute exacerbation of COPD (AECOPD)","definition_or_measurement_approach":""}
- {"endpoint_text":"- Annualized rate of severe AECOPD","definition_or_measurement_approach":""}
- {"endpoint_text":"- Time to first moderate-to-severe AECOPD","definition_or_measurement_approach":""}
- {"endpoint_text":"- Time to first severe AECOPD","definition_or_measurement_approach":""}
- {"endpoint_text":"- Change from baseline of the parent studies (EFC16750, EFC16819): Pre-BD and post-BD FEV1","definition_or_measurement_approach":""}
- {"endpoint_text":"- Change from baseline of the parent studies (EFC16750, EFC16819): SGRQ total score and domain scores","definition_or_measurement_approach":""}
- {"endpoint_text":"- Change from baseline of the parent studies (EFC16750, EFC16819): EQ-5D-5L single index score","definition_or_measurement_approach":""}
- {"endpoint_text":"- Change from baseline of the parent studies (EFC16750, EFC16819): EQ-VAS","definition_or_measurement_approach":""}
- {"endpoint_text":"- Change from Week 0 for CASA-Q","definition_or_measurement_approach":""}
Recruitment
- Planned Sample Size
- 475
- Recruitment Window Months
- 31
- Consent Approach
- Informed consent is required from participants (adult participants). Subject information and informed consent form documents are provided in multiple country languages as submitted (examples in the dossier include English, French, Spanish, German, Portuguese, Greek, Hungarian, Italian, Lithuanian, Latvian, Romanian, Slovak, Polish, Bulgarian). Specific assent/consent process details are not provided in the available record.
Geography
- Total Number Of Sites
- 87
- Total Number Of Participants
- 247
Bulgaria
- Earliest CTIS Part Ii Submission Date
- 12-04-2024
- Latest Decision Or Authorization Date
- 02-05-2024
- Processing Time Days
- 20
- Number Of Sites
- 15
- Number Of Participants
- 31
Sites
- Site Name
- Specialized Hospital For Active Treatment Of Pneumo-Physiatiric Diseases Dr. Treiman EOOD
- Department Name
- Pneumo-Physiatry Department
- Principal Investigator Name
- Stela Stefanova
- Principal Investigator Email
- stella_dencheva@mail.bg
- Contact Person Name
- Stela Stefanova
- Contact Person Email
- stella_dencheva@mail.bg
- Site Name
- Medical Center New Rehabilitation Center EOOD
- Department Name
- MC New rehabilitation center EOOD( #1)
- Principal Investigator Name
- Dimo Dimov
- Principal Investigator Email
- dmdimov65@yahoo.com
- Contact Person Name
- Dimo Dimov
- Contact Person Email
- dmdimov65@yahoo.com
- Site Name
- Specialized Hospital For Active Treatment Of Pneumo-Phthisiatric Diseases Dr. Dimitar Gramatikov-Ruse
- Department Name
- Physiatric Diseases Dr. Dimita
- Principal Investigator Name
- Hristo Metev
- Principal Investigator Email
- h_metev_2003@yahoo.com
- Contact Person Name
- Hristo Metev
- Contact Person Email
- h_metev_2003@yahoo.com
- Site Name
- Medical Center Pulmo-2018 EOOD
- Department Name
- Medical Center Pulmo-2018 EOOD (#1)
- Principal Investigator Name
- Veselin Kalfov
- Principal Investigator Email
- kalfov@abv.bg
- Contact Person Name
- Veselin Kalfov
- Contact Person Email
- kalfov@abv.bg
- Site Name
- Universitetska Parva Mnogoprofilna Bolnitsa Za Aktivno Lechenie Sofia Sv. Yoan Krastitel
- Department Name
- University First MHAT Sofia Sv. Yoan Krastitel EAD (#1)
- Principal Investigator Name
- Dinko Valev
- Principal Investigator Email
- dinko.g.valev@abv.bg
- Contact Person Name
- Dinko Valev
- Contact Person Email
- dinko.g.valev@abv.bg
- Site Name
- Multiprofile Hospital For Active Treatment Dr. Tota Venkova AD
- Department Name
- Department of Internal Disease
- Principal Investigator Name
- Krasimir Donchev
- Principal Investigator Email
- dr.krasimir.donchev@gmail.com
- Contact Person Name
- Krasimir Donchev
- Contact Person Email
- dr.krasimir.donchev@gmail.com
- Site Name
- Multiprofile Hospital For Active Treatment Blagoevgrad AD
- Department Name
- Internal Diseases Department
- Principal Investigator Name
- Elina Smilkova
- Principal Investigator Email
- dr.smilkova@mbalpuls.bg
- Contact Person Name
- Elina Smilkova
- Contact Person Email
- dr.smilkova@mbalpuls.bg
- Site Name
- Multiprofile Hospital For Active Treatment Knyaginya Klementina Sofia EAD
- Department Name
- Specialized Hospital for Active Treatment Joan Pavel OOD( #1)
- Principal Investigator Name
- Kalin Aleksandrov
- Principal Investigator Email
- k_alexandrov@abv.bg
- Contact Person Name
- Kalin Aleksandrov
- Contact Person Email
- k_alexandrov@abv.bg
- Site Name
- Prevencia 2000 MCDMP
- Department Name
- Preventsiya 2000 MCPMC OOD (#1)
- Principal Investigator Name
- Yanitsa Zhelyazkova
- Principal Investigator Email
- yanny_21@abv.bg
- Contact Person Name
- Yanitsa Zhelyazkova
- Contact Person Email
- yanny_21@abv.bg
- Site Name
- Medical Center Excelsior OOD
- Principal Investigator Name
- Todor Popov
- Principal Investigator Email
- ted.popov@gmail.com
- Contact Person Name
- Todor Popov
- Contact Person Email
- ted.popov@gmail.com
- Site Name
- Multi-Profile Hospital For Active Treatment Dr. Stamen Iliev AD
- Department Name
- Multiprofile Hospital for Active Treatment Dr. Stamen Iliev( #1)
- Principal Investigator Name
- Lidiya Nikolcheva-Todorova
- Principal Investigator Email
- dr.lidiya.nikolcheva@gmail.com
- Contact Person Name
- Lidiya Nikolcheva-Todorova
- Contact Person Email
- dr.lidiya.nikolcheva@gmail.com
- Site Name
- Medical Center Pulmovision Ltd.
- Department Name
- Pulmovision EODD (#1)
- Principal Investigator Name
- Miroslav Mihaylov
- Principal Investigator Email
- miroslavmihailov@abv.bg
- Contact Person Name
- Miroslav Mihaylov
- Contact Person Email
- miroslavmihailov@abv.bg
- Site Name
- Multiprofile Hospital For Active Treatment Sveta Ekaterina-Dimitrovgrad EOOD
- Department Name
- MHAT 'Sveta Ekaterina' EOOD( #1)
- Principal Investigator Name
- Todor Atanasov
- Principal Investigator Email
- todor.atanasow@gmail.com
- Contact Person Name
- Todor Atanasov
- Contact Person Email
- todor.atanasow@gmail.com
- Site Name
- Medical Center Sv. Ivan Rilski EOOD
- Department Name
- Medical Centre "Sveti Ivan Rilski" OOD (#1)
- Principal Investigator Name
- Ivo Iliev
- Principal Investigator Email
- ivo_pulmo@mail.bg
- Contact Person Name
- Ivo Iliev
- Contact Person Email
- ivo_pulmo@mail.bg
- Site Name
- Medical Center Prolet EOOD
- Department Name
- MC Prolet EOOD (#1)
- Principal Investigator Name
- Nikolay Nikolaev
- Principal Investigator Email
- nikolay.evgeniev@gmail.com
- Contact Person Name
- Nikolay Nikolaev
- Contact Person Email
- nikolay.evgeniev@gmail.com
Denmark
- Earliest CTIS Part Ii Submission Date
- 11-04-2024
- Latest Decision Or Authorization Date
- 29-04-2024
- Processing Time Days
- 18
- Number Of Sites
- 1
- Number Of Participants
- 5
Sites
- Site Name
- Lillebaelt Hospital
- Department Name
- Lung Clinic
- Principal Investigator Name
- Ole Hilberg
- Principal Investigator Email
- ole.hilberg@rsyd.dk
- Contact Person Name
- Ole Hilberg
- Contact Person Email
- ole.hilberg@rsyd.dk
Estonia
- Earliest CTIS Part Ii Submission Date
- 15-04-2024
- Latest Decision Or Authorization Date
- 30-04-2024
- Processing Time Days
- 15
- Number Of Sites
- 1
- Number Of Participants
- 5
Sites
- Site Name
- Tartu University Hospital
- Department Name
- Lung Clinic
- Principal Investigator Name
- Rain Jogi
- Principal Investigator Email
- rain.jogi@kliinikum.ee
- Contact Person Name
- Rain Jogi
- Contact Person Email
- rain.jogi@kliinikum.ee
Italy
- Earliest CTIS Part Ii Submission Date
- 15-04-2024
- Latest Decision Or Authorization Date
- 02-05-2024
- Processing Time Days
- 17
- Number Of Sites
- 5
- Number Of Participants
- 13
Sites
- Site Name
- Azienda Ospedaliero Universitaria Ospedali Riuniti
- Department Name
- Struttura Complessa Universitaria “Malattie Apparato Respiratorio”
- Principal Investigator Name
- Giulia Sciosica
- Principal Investigator Email
- giulia.scioscia@unifg.it
- Contact Person Name
- Giulia Sciosica
- Contact Person Email
- giulia.scioscia@unifg.it
- Site Name
- University Hospital Of Ferrara
- Department Name
- CEMICEF – Unità Operativa di Malattie dell’Apparato respiratorio
- Principal Investigator Name
- Alberto Papi
- Principal Investigator Email
- ppa@unife.it
- Contact Person Name
- Alberto Papi
- Contact Person Email
- ppa@unife.it
- Site Name
- Azienda Ospedaliero Universitaria Policlinico G Rodolico San Marco Di Catania
- Department Name
- U.O.C. di PNEUMOLOGIA
- Principal Investigator Name
- Claudia Crimi
- Principal Investigator Email
- dott.claudiacrimi@gmail.com
- Contact Person Name
- Claudia Crimi
- Contact Person Email
- dott.claudiacrimi@gmail.com
- Site Name
- Centro Ricerche Cliniche Di Verona S.r.l.
- Department Name
- U.O.C. di PNEUMOLOGIA
- Principal Investigator Name
- Claudio Micheletto
- Principal Investigator Email
- claudio.micheletto@aovr.veneto.it
- Contact Person Name
- Claudio Micheletto
- Contact Person Email
- claudio.micheletto@aovr.veneto.it
- Site Name
- Humanitas Research Hospital
- Department Name
- ASTHMA & ALLERGY CENTER - RESPIRATORY DISEASE UNIT
- Principal Investigator Name
- Francesca Antonietta Puggioni
- Principal Investigator Email
- francesca.puggioni@humanitas.it
- Contact Person Name
- Francesca Antonietta Puggioni
- Contact Person Email
- francesca.puggioni@humanitas.it
Latvia
- Earliest CTIS Part Ii Submission Date
- 21-04-2024
- Latest Decision Or Authorization Date
- 30-04-2024
- Processing Time Days
- 9
- Number Of Sites
- 1
- Number Of Participants
- 5
Sites
- Site Name
- Pauls Stradins Clinical University Hospital
- Department Name
- VSIA Paula Stradina kliniska universitates slimnica( #1)
- Principal Investigator Name
- Aurika Babjoniseva
- Principal Investigator Email
- aurikab@yahoo.co.uk
- Contact Person Name
- Aurika Babjoniseva
- Contact Person Email
- aurikab@yahoo.co.uk
Lithuania
- Earliest CTIS Part Ii Submission Date
- 16-04-2024
- Latest Decision Or Authorization Date
- 30-04-2024
- Processing Time Days
- 14
- Number Of Sites
- 1
- Number Of Participants
- 5
Sites
- Site Name
- Saules seimos medicinos centras UAB
- Department Name
- Saules Family Medicine Center( #1)
- Principal Investigator Name
- Alfredas Bagdonas
- Principal Investigator Email
- a.bagdonas@ssmc.lt
- Contact Person Name
- Alfredas Bagdonas
- Contact Person Email
- a.bagdonas@ssmc.lt
Portugal
- Earliest CTIS Part Ii Submission Date
- 11-04-2024
- Latest Decision Or Authorization Date
- 29-04-2024
- Processing Time Days
- 18
- Number Of Sites
- 7
- Number Of Participants
- 3
Sites
- Site Name
- Hospital Da Senhora Da Oliveira Guimaraes E.P.E.
- Department Name
- Hospital Da Senhora Da Oliveira( #1)
- Principal Investigator Name
- Catarina Guimaraes
- Principal Investigator Email
- 4080@hospitaldeguimaraes.min-saude.pt
- Contact Person Name
- Catarina Guimaraes
- Contact Person Email
- 4080@hospitaldeguimaraes.min-saude.pt
- Site Name
- CCAB Centro Clinico Academico Braga Associacao
- Department Name
- Hospital de Braga ( #1)
- Principal Investigator Name
- Ana Luisa Vieira
- Principal Investigator Email
- ana.l.vieira@hb.min-saude.pt
- Contact Person Name
- Ana Luisa Vieira
- Contact Person Email
- ana.l.vieira@hb.min-saude.pt
- Site Name
- Centro Hospitalar Do Baixo Vouga E.P.E. (CHBV E.P.E.)
- Department Name
- Centro Hospitalar de Baixo Vouga( #1)
- Principal Investigator Name
- Gilberto Teixeira
- Principal Investigator Email
- gilberto.teixeira.11443@chbv.min-saude.pt
- Contact Person Name
- Gilberto Teixeira
- Contact Person Email
- gilberto.teixeira.11443@chbv.min-saude.pt
- Site Name
- Centro Hospitalar E Universitario De Coimbra E.P.E.
- Department Name
- Centro Hospitalar e Universitario de Coimbra( #1)
- Principal Investigator Name
- Alcide Marques
- Principal Investigator Email
- 7153@chuc.min-saude.pt
- Contact Person Name
- Alcide Marques
- Contact Person Email
- 7153@chuc.min-saude.pt
- Site Name
- Hospital Garcia De Orta E.P.E.
- Department Name
- Hospital Garcia de Orta, EPE(#1)
- Principal Investigator Name
- Miguel Lopes
- Principal Investigator Email
- jmglps@gmail.com
- Contact Person Name
- Miguel Lopes
- Contact Person Email
- jmglps@gmail.com
- Site Name
- Unidade Local De Saude De Matosinhos E.P.E.
- Department Name
- Unidade Local de Saude de Matosinhos-Hospital Pedro Hispano(#1)
- Principal Investigator Name
- Joana Amado
- Principal Investigator Email
- minorquinha@yahoo.com
- Contact Person Name
- Joana Amado
- Contact Person Email
- minorquinha@yahoo.com
- Site Name
- Hospital Da Senhora Da Oliveira Guimaraes E.P.E.
- Department Name
- Hospital Da Senhora Da Oliveira( #1)
- Principal Investigator Name
- Catarina Guimaraes
- Principal Investigator Email
- 4080@hospitaldeguimaraes.min-saude.pt
- Contact Person Name
- Catarina Guimaraes
- Contact Person Email
- 4080@hospitaldeguimaraes.min-saude.pt
Netherlands
- Earliest CTIS Part Ii Submission Date
- 11-04-2024
- Latest Decision Or Authorization Date
- 29-04-2024
- Processing Time Days
- 18
- Number Of Sites
- 1
- Number Of Participants
- 7
Sites
- Site Name
- Amphia Hospital
- Department Name
- Pulmonary Medicine
- Principal Investigator Name
- Simone van der Sar
- Principal Investigator Email
- svandersar@amphia.nl
- Contact Person Name
- Simone van der Sar
- Contact Person Email
- svandersar@amphia.nl
Norway
- Earliest CTIS Part Ii Submission Date
- 16-04-2024
- Latest Decision Or Authorization Date
- 30-04-2024
- Processing Time Days
- 14
- Number Of Sites
- 1
- Number Of Participants
- 2
Sites
- Site Name
- Akershus University Hospital
- Department Name
- Department of Pulmonology
- Principal Investigator Name
- Gunnar Einvik
- Principal Investigator Email
- gunnar.einvik@ahus.no
- Contact Person Name
- Gunnar Einvik
- Contact Person Email
- gunnar.einvik@ahus.no
Poland
- Earliest CTIS Part Ii Submission Date
- 12-04-2024
- Latest Decision Or Authorization Date
- 02-05-2024
- Processing Time Days
- 20
- Number Of Sites
- 2
- Number Of Participants
- 35
Sites
- Site Name
- Centrum Medycyny Oddechowej Mroz Sp. j.
- Principal Investigator Name
- Robert Mroz
- Principal Investigator Email
- informacjacmo@gmail.com
- Contact Person Name
- Robert Mroz
- Contact Person Email
- informacjacmo@gmail.com
- Site Name
- Ostrowieckie Centrum Medyczne Anna Olech Cudzik Krzysztof Cudzik s.c.
- Principal Investigator Name
- Anna Olech-Cudzik
- Principal Investigator Email
- annacudzik@cudmed.pl
- Contact Person Name
- Anna Olech-Cudzik
- Contact Person Email
- annacudzik@cudmed.pl
Romania
- Earliest CTIS Part Ii Submission Date
- 30-01-2024
- Latest Decision Or Authorization Date
- 01-07-2024
- Processing Time Days
- 153
- Number Of Sites
- 8
- Number Of Participants
- 7
Sites
- Site Name
- Cabinet Medical de Pneumologie Bogdan-Mihai Mincu
- Department Name
- Cabinet Medical de Pneumologie Dr. Mincu Bogdan (#1)
- Principal Investigator Name
- Bogdan Mincu
- Principal Investigator Email
- mbmincu@gmail.com
- Contact Person Name
- Bogdan Mincu
- Contact Person Email
- mbmincu@gmail.com
- Site Name
- Impatiens S.R.L.
- Department Name
- Impatients SRL( #1)
- Principal Investigator Name
- Mihaela Malis-Gheghea
- Principal Investigator Email
- micki2001ro@yahoo.com
- Contact Person Name
- Mihaela Malis-Gheghea
- Contact Person Email
- micki2001ro@yahoo.com
- Site Name
- Clinica Medicala Data Plus S.R.L.
- Department Name
- Clinica Medicala Data Plus S.R.L. (#1)
- Principal Investigator Name
- Iulian Copaci
- Principal Investigator Email
- iulian_copaci@yahoo.com
- Contact Person Name
- Iulian Copaci
- Contact Person Email
- iulian_copaci@yahoo.com
- Site Name
- Centrul Medical De Diagnostic Si Tratament Ambulator Neomed S.R.L.
- Department Name
- Centrul Medical De Diagnostic Si Tratament Ambulator Neomed S.R.L.( #1)
- Principal Investigator Name
- Laurentia Andrei
- Principal Investigator Email
- dr.andrei@neomed.org
- Contact Person Name
- Laurentia Andrei
- Contact Person Email
- dr.andrei@neomed.org
- Site Name
- Fundatia Cardioprevent
- Department Name
- Fundatia Cardioprevent (#1)
- Principal Investigator Name
- Stefan Mihaicuta
- Principal Investigator Email
- stefan.mihaicuta@umft.ro
- Contact Person Name
- Stefan Mihaicuta
- Contact Person Email
- stefan.mihaicuta@umft.ro
- Site Name
- Spital De Pneumologie Dr. Lavinia Davidescu S.R.L.
- Department Name
- Spital de Pneumologie Dr. Lavinia Davidescu S.R.L.( #1)
- Principal Investigator Name
- Lavinia Davidescu
- Principal Investigator Email
- lavinia.davidescu@yahoo.com
- Contact Person Name
- Lavinia Davidescu
- Contact Person Email
- lavinia.davidescu@yahoo.com
- Site Name
- Angisan Grup S.R.L.
- Department Name
- Angisan Grup S.R.L. (#1)
- Principal Investigator Name
- Ana Trailescu
- Principal Investigator Email
- trailescuam@hotmail.com
- Contact Person Name
- Ana Trailescu
- Contact Person Email
- trailescuam@hotmail.com
- Site Name
- Medical Center S.R.L.
- Department Name
- Medical Center SRL( #1)
- Principal Investigator Name
- Ioan Petrui
- Principal Investigator Email
- ioandorinpetrui@yahoo.com
- Contact Person Name
- Ioan Petrui
- Contact Person Email
- ioandorinpetrui@yahoo.com
Greece
- Earliest CTIS Part Ii Submission Date
- 28-03-2024
- Latest Decision Or Authorization Date
- 15-07-2024
- Processing Time Days
- 109
- Number Of Sites
- 4
- Number Of Participants
- 18
Sites
- Site Name
- Athens Medical Center S.A.
- Department Name
- Pneumonology Clinic
- Principal Investigator Name
- Dimosthenis Papapetrou
- Principal Investigator Email
- dimospapapetroudsa@hotmail.com
- Contact Person Name
- Dimosthenis Papapetrou
- Contact Person Email
- dimospapapetroudsa@hotmail.com
- Site Name
- Evaggelismos Hospital
- Department Name
- Respiratory Department
- Principal Investigator Name
- Paraskevi Katsaounou
- Principal Investigator Email
- pkatsaoun@med.uoa.gr
- Contact Person Name
- Paraskevi Katsaounou
- Contact Person Email
- pkatsaoun@med.uoa.gr
- Site Name
- Geniko Nosokomeio Thessalonikis George Papanikolaou
- Department Name
- Pneumonology Clinic
- Principal Investigator Name
- Konstantinos Porpodis
- Principal Investigator Email
- kporpodis@yahoo.gr
- Contact Person Name
- Konstantinos Porpodis
- Contact Person Email
- kporpodis@yahoo.gr
- Site Name
- University General Hospital Of Ioannina
- Department Name
- University Pneumonology Clinic
- Principal Investigator Name
- Konstantinos Kostikas
- Principal Investigator Email
- ktkostikas@gmail.com
- Contact Person Name
- Konstantinos Kostikas
- Contact Person Email
- ktkostikas@gmail.com
Hungary
- Earliest CTIS Part Ii Submission Date
- 16-04-2024
- Latest Decision Or Authorization Date
- 22-07-2024
- Processing Time Days
- 97
- Number Of Sites
- 7
- Number Of Participants
- 12
Sites
- Site Name
- Budapesti Bajcsy-Zsilinszky Korhaz Es Rendelointezet
- Department Name
- Monori Rendelointezete, Tudogyogyaszat-Tudogondozo II.
- Principal Investigator Name
- Zoltan Bende
- Principal Investigator Email
- zoltan.bende@freemail.hu
- Contact Person Name
- Zoltan Bende
- Contact Person Email
- zoltan.bende@freemail.hu
- Site Name
- Erzsebet Gondozohaz Kft.
- Department Name
- Erzsebet Gondozohaz Kft.( #1)
- 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
- Principal Investigator Name
- Edina Kurucz
- Principal Investigator Email
- drkuruczedina@gmail.com
- Contact Person Name
- Edina Kurucz
- Contact Person Email
- drkuruczedina@gmail.com
- Site Name
- Omnimodus Elixir 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
- Koch Robert Korhaz Es Rendelointezet
- Department Name
- Specialized Hospital for Active Treatment Joan Pavel OOD( #1)
- Principal Investigator Name
- Melinda Szabo
- Principal Investigator Email
- pulmo.szbt@gmail.com
- Contact Person Name
- Melinda Szabo
- Contact Person Email
- pulmo.szbt@gmail.com
- Site Name
- Puspokladanyi Egeszsegugyi Szolgaltato Nonprofit Kft.
- Department Name
- Tudogondozo
- Principal Investigator Name
- Nelli Kosztyu
- Principal Investigator Email
- nellypharmanex@gmail.com
- Contact Person Name
- Nelli Kosztyu
- Contact Person Email
- nellypharmanex@gmail.com
- Site Name
- Vas Varmegyei Markusovszky Egyetemi Oktatokorhaz
- Department Name
- Tudogyogyaszati Osztaly
- Principal Investigator Name
- Zsuzsanna Cseke
- Principal Investigator Email
- csekezs@t-email.hu
- Contact Person Name
- Zsuzsanna Cseke
- Contact Person Email
- csekezs@t-email.hu
Czechia
- Earliest CTIS Part Ii Submission Date
- 15-04-2024
- Latest Decision Or Authorization Date
- 26-07-2024
- Processing Time Days
- 102
- Number Of Sites
- 3
- Number Of Participants
- 23
Sites
- Site Name
- MediTrial s.r.o.
- Department Name
- MediTrial s.r.o.( #1)
- Principal Investigator Name
- Petr Kopecky jr.
- Principal Investigator Email
- kopir@post.cz
- Contact Person Name
- Petr Kopecky jr.
- Contact Person Email
- kopir@post.cz
- Site Name
- Plicni centrum s.r.o.
- Department Name
- Plicni centrum s.r.o. (#1)
- Principal Investigator Name
- Pavel Spas
- Principal Investigator Email
- spaspavel@seznam.cz
- Contact Person Name
- Pavel Spas
- Contact Person Email
- spaspavel@seznam.cz
- Site Name
- Plicni ordinace s.r.o.
- Department Name
- Plicni ordinace s.r.o. (#1)
- Principal Investigator Name
- Marie Buresova
- Principal Investigator Email
- bures.marie@seznam.cz
- Contact Person Name
- Marie Buresova
- Contact Person Email
- bures.marie@seznam.cz
Slovakia
- Earliest CTIS Part Ii Submission Date
- 16-04-2024
- Latest Decision Or Authorization Date
- 19-07-2024
- Processing Time Days
- 94
- Number Of Sites
- 4
- Number Of Participants
- 11
Sites
- Site Name
- Plucna ambulancia Hrebenar s.r.o.
- Department Name
- Plucna ambulancia Hrebenar s.r.o.( #1)
- Principal Investigator Name
- Slavomir Hrebenar
- Principal Investigator Email
- hrebenars@gmail.com
- Contact Person Name
- Slavomir Hrebenar
- Contact Person Email
- hrebenars@gmail.com
- Site Name
- Zapa Jj s.r.o.
- Department Name
- ZAPA JJ s.r.o( #1)
- Principal Investigator Name
- Jan Plutinsky
- Principal Investigator Email
- plutinskyjan@gmail.com
- Contact Person Name
- Jan Plutinsky
- Contact Person Email
- plutinskyjan@gmail.com
- Site Name
- Inspiro s.r.o.
- Department Name
- INSPIRO, s.r.o.( #1)
- Principal Investigator Name
- Alexander Golubov
- Principal Investigator Email
- agolubov0904@gmail.com
- Contact Person Name
- Alexander Golubov
- Contact Person Email
- agolubov0904@gmail.com
- Site Name
- PULMO s.r.o.
- Department Name
- PULMO s.r.o. (#1)
- Principal Investigator Name
- Luboslava Frajtova
- Principal Investigator Email
- lfrajtova@gmail.com
- Contact Person Name
- Luboslava Frajtova
- Contact Person Email
- lfrajtova@gmail.com
France
- Earliest CTIS Part Ii Submission Date
- 15-02-2024
- Latest Decision Or Authorization Date
- 10-12-2024
- Processing Time Days
- 299
- Number Of Sites
- 6
- Number Of Participants
- 6
Sites
- Site Name
- Centre Hospitalier Universitaire Reims
- Department Name
- CHU de Reims-Service maladies respiratoires
- Principal Investigator Name
- Gaetan Deslee
- Principal Investigator Email
- gdeslee@chu-reims.fr
- Contact Person Name
- Gaetan Deslee
- Contact Person Email
- gdeslee@chu-reims.fr
- Site Name
- Centre Hospitalier Universitaire De Bordeaux
- Department Name
- CHU de Bordeaux-Hopital Haut Leveque-Centre d'Investigation Clinique Plurithématique, unité pneumolo
- Principal Investigator Name
- Pierre-Olivier Girodet
- Principal Investigator Email
- pierre-olivier.girodet@chu-bordeaux.fr
- Contact Person Name
- Pierre-Olivier Girodet
- Contact Person Email
- pierre-olivier.girodet@chu-bordeaux.fr
- Site Name
- Hospices Civils De Lyon
- Department Name
- Hôpital La Croix Rousse-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
- Assistance Publique Hopitaux De Paris
- Department Name
- Hôpital La Pitié Salpétrière-Respiratory and neuro-respiratory and rehabilitation care
- Principal Investigator Name
- Jesus GONZALEZ
- Principal Investigator Email
- jesus.gonzalez@aphp.fr
- Contact Person Name
- Jesus GONZALEZ
- Contact Person Email
- jesus.gonzalez@aphp.fr
- Site Name
- Centre Hospitalier Universitaire D'Angers
- Department Name
- CHU d' ANGERS-Service de Pneumologie et Allergologie
- Principal Investigator Name
- Frederic GAGNADOUX
- Principal Investigator Email
- frgagnadoux@chu-angers.fr
- Contact Person Name
- Frederic GAGNADOUX
- Contact Person Email
- frgagnadoux@chu-angers.fr
- Site Name
- University Hospital Of Montpellier
- Department Name
- "Service des maladies respiratoires-CHRU de Montpellier - Hôpital Arnaud de Villeneuve"
- 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
Spain
- Earliest CTIS Part Ii Submission Date
- 12-04-2024
- Latest Decision Or Authorization Date
- 19-11-2025
- Processing Time Days
- 586
- Number Of Sites
- 11
- Number Of Participants
- 18
Sites
- Site Name
- Hospital San Pedro De Alcantara
- Department Name
- HOSPITAL SAN PEDRO DE ALCANTARA
- Principal Investigator Name
- Juan Antonio Riesco Miranda
- Principal Investigator Email
- jantonio.riesco@gmail.com
- Contact Person Name
- Juan Antonio Riesco Miranda
- Contact Person Email
- jantonio.riesco@gmail.com
- Site Name
- Giromed Institute S.L.P.
- Department Name
- GIROMED-CLINICA MI TRES TORRES
- 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
- Hospital Universitario Marques De Valdecilla
- Department Name
- HOSPITAL UNIVERSITARIO MARQUÉS DE VALDECILLA-Valdec
- Principal Investigator Name
- Juan Luis Garcia Rivero
- Principal Investigator Email
- juanluis.garcia@scsalud.es
- Contact Person Name
- Juan Luis Garcia Rivero
- Contact Person Email
- juanluis.garcia@scsalud.es
- Site Name
- Parc Sanitari Sant Joan De Deu
- Department Name
- Parc Sanitari Sant Joan de Deu (#1)
- Principal Investigator Name
- Alejandra Lopez Giraldo
- Principal Investigator Email
- alejandra.lopez@sjd.es
- Contact Person Name
- Alejandra Lopez Giraldo
- Contact Person Email
- alejandra.lopez@sjd.es
- Site Name
- University Hospital Son Espases
- Department Name
- HOSPITAL UNIVERSITARI SON ESPASES-HSonEsp
- 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 Universitario Quironsalud Madrid
- Department Name
- Hospital Universitario Quironsalud Madrid (#1)
- Principal Investigator Name
- JOSE ECHAVE-SUSTAETA
- Principal Investigator Email
- jose.echave@quironsalud.es
- Contact Person Name
- JOSE ECHAVE-SUSTAETA
- Contact Person Email
- jose.echave@quironsalud.es
- Site Name
- Hospital General Universitario Gregorio Maranon
- Department Name
- Hospital General Universitario Gregorio Maranon (#1)
- 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
- Hospital Universitario Fundacion Jimenez Diaz
- Department Name
- Fundacion Jimenez Diaz( #1)
- Principal Investigator Name
- Carolina Gotera
- Principal Investigator Email
- carolina.gotera@fjd.es
- Contact Person Name
- Carolina Gotera
- Contact Person Email
- carolina.gotera@fjd.es
- Site Name
- Hospital Universitario Virgen De La Victoria
- Department Name
- Hospital Virgen de la Victoria( #1)
- 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 Unviersitario Miguel Servet
- Department Name
- Hospital Universitario Miguel Servet( #1)
- Principal Investigator Name
- Marta Marin Oto
- Principal Investigator Email
- marta.marin.oto@gmail.com
- Contact Person Name
- Marta Marin Oto
- Contact Person Email
- marta.marin.oto@gmail.com
- Site Name
- Hospital San Pedro De Alcantara (additional listed site)
- Department Name
- HOSPITAL SAN PEDRO DE ALCANTARA
- Principal Investigator Name
- Juan Antonio Riesco Miranda
- Principal Investigator Email
- jantonio.riesco@gmail.com
- Contact Person Name
- Juan Antonio Riesco Miranda
- Contact Person Email
- jantonio.riesco@gmail.com
Germany
- Earliest CTIS Part Ii Submission Date
- 18-04-2024
- Latest Decision Or Authorization Date
- 06-01-2026
- Processing Time Days
- 628
- Number Of Sites
- 9
- Number Of Participants
- 41
Sites
- Site Name
- IKF Pneumologie GmbH & Co. KG
- Department Name
- IKF Pneumologie Mainz
- Principal Investigator Name
- Stephanie Korn
- Principal Investigator Email
- korn@ikf-pneumologie.de
- Contact Person Name
- Stephanie Korn
- Contact Person Email
- korn@ikf-pneumologie.de
- Site Name
- Institut fur Allergie und Asthmaforschung Berlin, IAAB
- Department Name
- Institut fur Allergie und Asthmaforschung Berlin, IAAB (#1)
- Principal Investigator Name
- Matthias Kruell
- Principal Investigator Email
- kruell@pneumologie-berlin.de
- Contact Person Name
- Matthias Kruell
- Contact Person Email
- kruell@pneumologie-berlin.de
- Site Name
- KPPK GmbH
- Department Name
- KPPK Studienzentrum GmbH( #1)
- Principal Investigator Name
- Olaf Schmidt
- Principal Investigator Email
- schmidt@kppk-gmbh.de
- Contact Person Name
- Olaf Schmidt
- Contact Person Email
- schmidt@kppk-gmbh.de
- Site Name
- Romed Klinikum Rosenheim
- Department Name
- Medizinische Klinik III
- Principal Investigator Name
- Stephan Budweiser
- Principal Investigator Email
- stephan.budweiser@ro-med.de
- Contact Person Name
- Stephan Budweiser
- Contact Person Email
- stephan.budweiser@ro-med.de
- Site Name
- Velocity Clinical Research Germany GmbH
- Department Name
- KLB Gesundheitsforschung Lubeck GmbH( #1)
- Principal Investigator Name
- Nakul Modi
- Principal Investigator Email
- nmodi@velocityclinical.com
- Contact Person Name
- Nakul Modi
- Contact Person Email
- nmodi@velocityclinical.com
- Site Name
- Berufsausuebungsgemeinschaft Bag Prof Dr. Med Gerhard Hoheisel Dr. Med Andreas Bonitz GbR
- Department Name
- Praxis fur Pneumologie und Allergologie (#1)
- Principal Investigator Name
- Andreas Bonitz
- Principal Investigator Email
- abonitz@gmx.de
- Contact Person Name
- Andreas Bonitz
- Contact Person Email
- abonitz@gmx.de
- Site Name
- IKF Pneumologie GmbH & Co. KG (Frankfurt address)
- Department Name
- IKF Pneumologie GmbH & Co. KG (#1)
- Principal Investigator Name
- Marc Oliver Kornmann
- Principal Investigator Email
- kornmann@ikf-pneumologie.de
- Contact Person Name
- Marc Oliver Kornmann
- Contact Person Email
- kornmann@ikf-pneumologie.de
- Site Name
- POIS Sachsen GmbH
- Department Name
- POIS Leipzig GmbH
- Principal Investigator Name
- Falk Brunner
- Principal Investigator Email
- f.brunner@pois-sachsen.de
- Contact Person Name
- Falk Brunner
- Contact Person Email
- f.brunner@pois-sachsen.de
- Site Name
- Romed Klinikum Rosenheim (additional listing)
- Department Name
- Medizinische Klinik III
- Principal Investigator Name
- Stephan Budweiser
- Principal Investigator Email
- stephan.budweiser@ro-med.de
- Contact Person Name
- Stephan Budweiser
- Contact Person Email
- stephan.budweiser@ro-med.de
Sponsor
Primary sponsor
- Full Name
- Sanofi-Aventis Recherche & Developpement
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- France
Contract research organisations
- Name
- PPD Development LP
- Name
- eResearchTechnology GmbH / Eresearchtechnology Inc.
- Responsibilities
- Spirometry and cardiac safety
- Name
- Endpoint Clinical Inc.
Third parties
- {"country":"Germany","full_name":"eResearchTechnology GmbH","duties_or_roles":"Spirometry and cardiac safety","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"ESMS Global Limited","duties_or_roles":"Centralized 24-hour Emergency System: eSMS","organisation_type":"Pharmaceutical company"}
- {"country":"Czechia","full_name":"PHOENIX lekarensky velkoobchod s.r.o.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"PPD Development LP","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"Hungary","full_name":"PetMobile Kft.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"Spain","full_name":"Alcura Health Espana S.A.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"Poland","full_name":"Pharmalink Sp. z o.o.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"Italy","full_name":"Depo-pack S.r.l.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"Germany","full_name":"Azenta Germany GmbH","duties_or_roles":"Sample long term storage","organisation_type":"Pharmaceutical company"}
- {"country":"Romania","full_name":"Alliance Healthcare Romania S.R.L.","duties_or_roles":"Medical Device Management","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Endpoint Clinical Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- Itepekimab
- Active Substance
- ITEPEKIMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- SUBCUTANEOUS
- Route
- SUBCUTANEOUS
- Authorisation Status
- 1
- Maximum Dose
- 300 mg (maxDailyDoseAmount 300 mg)
- Investigational Product Name
- Matched Placebo for test product
- Modality
- Other
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