Clinical trial • Phase III • Respiratory

DEPEMOKIMAB for Chronic Obstructive Pulmonary Disease (COPD)

Phase III trial of DEPEMOKIMAB for Chronic Obstructive Pulmonary Disease (COPD).

Overview

Trial Therapeutic Area
Respiratory
Trial Disease
Chronic Obstructive Pulmonary Disease (COPD)
Trial Stage
Phase III
Drug Modality
Monoclonal antibody

Key dates

Initial CTIS Submission Date
01-08-2025
First CTIS Authorization Date
24-11-2025

Trial design

Randomised, placebo (sterile 0.9% (w/v) sodium chloride solution in single-use pfs) plus standard of care (soc). dose and schedule for placebo not specified in the ctis record. standard of care defined as optimized inhaler therapy (ics + lama + laba) for at least 6 months prior to screening.-controlled Phase III trial across 73 sites in Latvia, Austria, Greece and others.

Randomised
Yes
Comparator
Placebo (Sterile 0.9% (w/v) sodium chloride solution in single-use PFS) plus standard of care (SoC). Dose and schedule for placebo not specified in the CTIS record. Standard of care defined as optimized inhaler therapy (ICS + LAMA + LABA) for at least 6 months prior to screening.
Target Sample Size
633
Trial Duration For Participant
728

Eligibility

Recruits 633 isVulnerablePopulationSelected = true; the submission includes dedicated informed consent documents for special populations (e.g., 'Pregnant-Participant-ICF' documents listed for multiple countries). Informed consent is obtained via the Main ICF documents; specific ICFs are provided for pregnant participants and for optional PK/genetic sub-studies. No assent process for minors is described (study includes adult participants only)..

Vulnerable Population
isVulnerablePopulationSelected = true; the submission includes dedicated informed consent documents for special populations (e.g., 'Pregnant-Participant-ICF' documents listed for multiple countries). Informed consent is obtained via the Main ICF documents; specific ICFs are provided for pregnant participants and for optional PK/genetic sub-studies. No assent process for minors is described (study includes adult participants only).

Inclusion criteria

  • {"criterion_text":"- 1. Participants must be greater than or equal to (>=) 40 to less than or equal to (<=) 80 years of age, at the time of signing the Informed consent"}
  • {"criterion_text":"- 2. Elevated Blood Eosinophil Count (BEC)"}
  • {"criterion_text":"- 3. Moderate to severe COPD with frequent exacerbations, defined as: o A clinically documented history of COPD as defined by the American Thoracic Society/European Respiratory Society for at least 1 year o A post-bronchodilator forced expiratory volume in one second (FEV1)/ forced vital capacity (FVC) ratio of < 0.70 and a post-bronchodilator FEV1 >30 percent (%) and <= 80% predicted normal values o A well-documented history of at least 2 moderate or 1 severe exacerbation in the 12 months prior to screening"}
  • {"criterion_text":"- 4. COPD assessment test (CAT) score >=10 at Visit 1"}
  • {"criterion_text":"- 5. Smoking status: Current or former cigarette smokers with a history of cigarette smoking of >=10 pack-years."}
  • {"criterion_text":"- 6. Participants should be on optimized inhaler therapy, defined as inhaled corticosteroid (ICS) plus Long-acting muscarinic receptor antagonist (LAMA) plus Long-acting beta2-adrenergic receptor agonist (LABA) either as multiple inhalers or a single combination inhaler for at least 6 months prior to Screening Visit 1"}
  • {"criterion_text":"- 7. Body mass index (BMI) >=16 kilogram per square meter (kg/m^2)"}
  • {"criterion_text":"- 8. Male and eligible female participants"}

Exclusion criteria

  • {"criterion_text":"- 1. Participants with a current or prior physician diagnosis of asthma"}
  • {"criterion_text":"- 10. Parasitic Infection: Participants with a known, pre-existing parasitic infection within 6 months of Screening (Visit 1)"}
  • {"criterion_text":"- 2. Other clinically significant lung disease: The Investigator must judge that COPD is the primary diagnosis accounting for the clinical manifestations of the lung disease"}
  • {"criterion_text":"- 3. Participants with pneumonia, COPD exacerbation, or lower respiratory tract infection within the 4 weeks prior to Screening Visit 1"}
  • {"criterion_text":"- 4. Lung resection: Participants with a history of or plan for lung volume reduction surgery / endobronchial valve procedure."}
  • {"criterion_text":"- 5. Pulmonary rehabilitation: Participants in the acute phase of a pulmonary rehabilitation program within 4 weeks prior to Screening Visit 1"}
  • {"criterion_text":"- 6. Continuous oxygen: Participants requiring oxygen supplementation for more than 12 hours per day"}
  • {"criterion_text":"- 7. Cor pulmonale – resulting in right heart failure, severe pulmonary hypertension"}
  • {"criterion_text":"- 8. Chronic hypercapnia requiring Non-invasive positive pressure ventilation (NIPPV) use (including Bi-Level Positive Airway Pressure [BiPAP] or Continuous Positive Airway Pressure [CPAP])"}
  • {"criterion_text":"- 9. Unstable cardiovascular disease or arrhythmia"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Annualized Rate of Moderate/Severe Exacerbations","definition_or_measurement_approach":""}

Secondary endpoints

  • {"endpoint_text":"- 1. Time to First Moderate/Severe Exacerbation","definition_or_measurement_approach":""}
  • {"endpoint_text":"- 2. Change from Baseline in St. George’s Respiratory Questionnaire (SGRQ) Total Score at Week 52","definition_or_measurement_approach":"Measured at Week 52"}
  • {"endpoint_text":"- 3. Change from Baseline in Evaluating Respiratory Symptoms in Chronic Obstructive Pulmonary Disease (E-RS: COPD) Total Score at Week 52","definition_or_measurement_approach":"Measured at Week 52"}
  • {"endpoint_text":"- 4. Annualized Rate of Exacerbations Requiring Emergency Department (ED) Visit or Hospitalization","definition_or_measurement_approach":""}
  • {"endpoint_text":"- 5. Annualized Rate of Severe Exacerbations","definition_or_measurement_approach":""}

Recruitment

Digital Remote Recruitment
Yes
Planned Sample Size
633
Recruitment Window Months
48
Consent Approach
Informed consent obtained from individual participants via country-specific Main ICF documents. Country- and situation-specific ICFs are provided (Main ICF, Pregnant-Participant ICF, Optional PK ICF, Optional Genetic Research ICF). ICF languages and versions are provided per country (examples include Latvian, Russian, German, Greek, Bulgarian, English, Romanian, Italian, Czech). Participants are adults (no assent described); consent is provided by the participant.

Methods

  • Site-based materials: doctor letters, patient letters, patient flyers, recruitment brochures and site flipcharts (country-specific versions available: DE, AT, CZ, LV, GRC, BGR, RO, IT, etc.)
  • Appointment reminder cards (country-specific) to support retention and scheduling
  • Site communications templates including COPD-specific recruitment text and social templates (e.g., 'Social templates' for Czechia)
  • Email communications via third-party provider (Scout) including welcome/email communications (document L2_222725_Scout_PFD-Welcomme-Email-Communication_CZ_Czech_Public)
  • Country-specific recruitment arrangements documents (K1/K2) detailing outreach to patients and HCPs in each Member State

Geography

Total Number Of Sites
73
Total Number Of Participants
327

Latvia

Earliest CTIS Part Ii Submission Date
24-10-2025
Latest Decision Or Authorization Date
28-11-2025
Processing Time Days
35
Number Of Sites
3
Number Of Participants
11

Sites

Site Name
Veselibas centru apvieniba AS
Department Name
Outpatient Clinic OLVI
Principal Investigator Name
Lilita Mitrofanova
Principal Investigator Email
lilita.m@inbox.eu
Contact Person Name
Lilita Mitrofanova
Contact Person Email
lilita.m@inbox.eu
Site Name
Rigas Austrumu kliniska universitates slimnica SIA
Principal Investigator Name
Inga Stukena
Principal Investigator Email
inga.stukena@gmail.com
Contact Person Name
Inga Stukena
Contact Person Email
inga.stukena@gmail.com
Site Name
Pauls Stradins Clinical University Hospital
Principal Investigator Name
Aurika Babjoniseva
Principal Investigator Email
aurikab@yahoo.co.uk
Contact Person Name
Aurika Babjoniseva
Contact Person Email
aurikab@yahoo.co.uk

Austria

Earliest CTIS Part Ii Submission Date
27-10-2025
Latest Decision Or Authorization Date
01-12-2025
Processing Time Days
35
Number Of Sites
7
Number Of Participants
41

Sites

Site Name
Johannes Kepler University Linz
Department Name
Kepler University Hospital, University Clinic for Internal Medicine 4 – Pneumology
Principal Investigator Name
Andreas Horner
Principal Investigator Email
andreas.horner@kepleruniklinikum.at
Contact Person Name
Andreas Horner
Site Name
Medical University Of Vienna
Department Name
Medical University Vienna, Department of Internal Medicine II, Division of Pulmonology
Principal Investigator Name
Marco Izdko
Principal Investigator Email
marco.idzko@meduniwien.ac.at
Contact Person Name
Marco Izdko
Contact Person Email
marco.idzko@meduniwien.ac.at
Site Name
Private Practice Dr. Michael Würtz - Pulmonologist
Department Name
Ordination Dr. Michael Würtz- Facharzt für Lungenkrankheiten
Principal Investigator Name
Michael Würtz
Principal Investigator Email
ordination@wuertz.at
Contact Person Name
Michael Würtz
Contact Person Email
ordination@wuertz.at
Site Name
Medical University Of Graz
Department Name
Dept. of Internal Medicine, Division of Resp. Medicine, Lung Res. Cluster, Auenbruggerplatz 20
Principal Investigator Name
Katrin Milger-Kneidinger
Principal Investigator Email
katrin.milger-kneidinger@medunigraz.at
Contact Person Name
Katrin Milger-Kneidinger
Site Name
Ordensklinikum Linz GmbH
Department Name
Order Hospital Linz GmbH – Elisabethinen - Pneumology
Principal Investigator Name
Christopher Lambers
Principal Investigator Email
christopher.lambers@ordensklinikum.at
Contact Person Name
Christopher Lambers
Site Name
Medizinische Universitaet Innsbruck
Department Name
Medical University Innsbruck, Department of Internal Medicine II – Pneumology
Principal Investigator Name
Thomas Sonnweber
Principal Investigator Email
thomas.sonnweber@i-med.ac.at
Contact Person Name
Thomas Sonnweber
Contact Person Email
thomas.sonnweber@i-med.ac.at
Site Name
Landeskrankenanstalten-Betriebsgesellschaft Kabeg
Department Name
Clinic Klagenfurt am Wörthersee, Department of Internal Medicine and Pneumology
Principal Investigator Name
Daniel Doberer
Principal Investigator Email
daniel.doberer@kabeg.at
Contact Person Name
Daniel Doberer
Contact Person Email
daniel.doberer@kabeg.at

Greece

Earliest CTIS Part Ii Submission Date
12-11-2025
Latest Decision Or Authorization Date
24-11-2025
Processing Time Days
12
Number Of Sites
6
Number Of Participants
33

Sites

Site Name
Athens Medical Center S.A.
Department Name
Pulmonary Clinic
Principal Investigator Name
Anastasios Palamidas
Principal Investigator Email
palamidastasos@icloud.com
Contact Person Name
Anastasios Palamidas
Contact Person Email
palamidastasos@icloud.com
Site Name
Geniko Nosokomeio Thessalonikis George Papanikolaou
Department Name
Respiratory Department of Aristotle University Medical School in Thessalonik
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
Pulmonary 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
Athens Naval Hospital
Department Name
Pulmonary Department
Principal Investigator Name
Nikolaos Zias
Principal Investigator Email
nikoszias@gmail.com
Contact Person Name
Nikolaos Zias
Contact Person Email
nikoszias@gmail.com
Site Name
University General Hospital Of Alexandroupoli
Department Name
University Department of Respiratory Medicine
Principal Investigator Name
Pascalis Steiropoulos
Principal Investigator Email
steiropoulos@yahoo.com
Contact Person Name
Pascalis Steiropoulos
Contact Person Email
steiropoulos@yahoo.com
Site Name
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara
Department Name
2nd Pulmonology Clinic
Principal Investigator Name
Stelios Loukides
Principal Investigator Email
loukstel@med.uoa.gr
Contact Person Name
Stelios Loukides
Contact Person Email
loukstel@med.uoa.gr

Germany

Earliest CTIS Part Ii Submission Date
27-10-2025
Latest Decision Or Authorization Date
25-11-2025
Processing Time Days
29
Number Of Sites
21
Number Of Participants
90

Sites

Site Name
Clinical Studies Pankow Ishak Teber
Principal Investigator Name
Ishak Teber
Principal Investigator Email
i.teber@gmx.de
Contact Person Name
Ishak Teber
Contact Person Email
i.teber@gmx.de
Site Name
Pneumologisches Forschungszentrum Hohegeest GbR
Principal Investigator Name
Wolfgang Zachgo
Principal Investigator Email
wz@lungenzentrum-geesthacht.de
Contact Person Name
Wolfgang Zachgo
Contact Person Email
wz@lungenzentrum-geesthacht.de
Site Name
Velocity Clinical Research Germany GmbH
Principal Investigator Name
Nakul Modi
Principal Investigator Email
nmodi@velocityclinical.com
Contact Person Name
Nakul Modi
Contact Person Email
nmodi@velocityclinical.com
Site Name
Lungenpraxis Hohenzollerndamm
Department Name
Research Center for Medical Studies (RCMS)
Principal Investigator Name
Björn Martens
Contact Person Name
Björn Martens
Site Name
FutureMeds GmbH
Department Name
FutureMeds Study Site Offenbach
Principal Investigator Name
Florieke Joanne Berfelo
Principal Investigator Email
Florieke.berfelo@futuremeds.com
Contact Person Name
Florieke Joanne Berfelo
Site Name
Lungenfachklinik Immenhausen
Department Name
Zentrum für Pneumologie
Principal Investigator Name
Peter Hammerl
Principal Investigator Email
hammerl@lungenfachklinik-immenhausen.de
Contact Person Name
Peter Hammerl
Site Name
KPPK GmbH
Principal Investigator Name
Olaf Schmidt
Principal Investigator Email
schmidt@kppk-gmbh.de
Contact Person Name
Michael Würtz
Contact Person Email
schmidt@kppk-gmbh.de
Site Name
POIS Sachsen 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
Lungenarztpraxis Hellersdorf
Principal Investigator Name
Jens Driemert
Principal Investigator Email
praxis-driemert@gmx.de
Contact Person Name
Jens Driemert
Contact Person Email
praxis-driemert@gmx.de
Site Name
Salvus-Klinische Studien GmbH
Principal Investigator Name
Regina Deckelmann
Principal Investigator Email
studien@dr-deckelmann.de
Contact Person Name
Regina Deckelmann
Contact Person Email
studien@dr-deckelmann.de
Site Name
Pneumologisches Studienzentrum MVZ die Lungenärzte Gesundheitszentrum
Principal Investigator Name
Hilke Temme
Principal Investigator Email
temme@die-lungenaerzte.de
Contact Person Name
Hilke Temme
Contact Person Email
temme@die-lungenaerzte.de
Site Name
Universitaetsklinikum des Saarlandes AöR
Department Name
Klinik für Innere Medizin V, Gebäude 41
Principal Investigator Name
Robert Bals
Principal Investigator Email
robert.bals@uks.eu
Contact Person Name
Robert Bals
Contact Person Email
robert.bals@uks.eu
Site Name
Framol-Med GmbH
Principal Investigator Name
Marc Höffgen
Principal Investigator Email
hoeffgen@lungenpraxis-rheine.de
Contact Person Name
Marc Höffgen
Site Name
Praxis für Pneumologie
Principal Investigator Name
Athanasios Xanthopoulos
Principal Investigator Email
sakis123de@yahoo.de
Contact Person Name
Athanasios Xanthopoulos
Contact Person Email
sakis123de@yahoo.de
Site Name
Universitaetsklinikum Essen AöR
Department Name
Ambulantes Lungenzentrum Essen, Am Handelshof 1, 45127 Essen
Principal Investigator Name
Sivagurunathan Sutharsan
Principal Investigator Email
sivagurunathan.sutharsan@rlk.uk-essen.de
Contact Person Name
Sivagurunathan Sutharsan
Site Name
Pneumo Studien Darmstadt GmbH
Principal Investigator Name
Andreas Forster
Principal Investigator Email
forster@pneumostudien-darmstadt.de
Contact Person Name
Andreas Forster
Site Name
Siteworks GmbH
Department Name
Prüfzentrum Schleswig | RespiRatio angegliedert an die Lungenpraxis Schleswig
Principal Investigator Name
Andreas Deimling
Principal Investigator Email
deimling.andreas@gmx.de
Contact Person Name
Andreas Deimling
Contact Person Email
deimling.andreas@gmx.de
Site Name
Studienpraxis Berlin-Brandenburg Cornelia Seelbinder Und Lennart Schaper GbR
Principal Investigator Name
Lennart Schaper
Principal Investigator Email
lennart.schaper@studienpraxis-bb.de
Contact Person Name
Lennart Schaper
Site Name
MECS Research GmbH
Principal Investigator Name
Thomas Schultz
Principal Investigator Email
schultz@mecs-research.de
Contact Person Name
Thomas Schultz
Contact Person Email
schultz@mecs-research.de
Site Name
Pneumologicum Halle Dr. med. Peter-Uwe Haase
Principal Investigator Name
Peter-Uwe Haase
Principal Investigator Email
peteruwehaase@pneumologicum-halle.de
Contact Person Name
Peter-Uwe Haase
Site Name
Lungenärzte am Rundfunkplatz
Principal Investigator Name
Korkut Avsar
Principal Investigator Email
dravsar@lungenaerzte-am-rundfunkplatz.de
Contact Person Name
Korkut Avsar

Czechia

Earliest CTIS Part Ii Submission Date
27-10-2025
Latest Decision Or Authorization Date
24-11-2025
Processing Time Days
28
Number Of Sites
5
Number Of Participants
25

Sites

Site Name
Nemocnice Nymburk s.r.o.
Department Name
Plicni ambulance
Principal Investigator Name
Sárka Klimesová
Principal Investigator Email
sarka.klimes@atlas.cz
Contact Person Name
Sárka Klimesová
Contact Person Email
sarka.klimes@atlas.cz
Site Name
Synexus Czech s.r.o.
Principal Investigator Name
Zuzana Kalciková Boucková
Principal Investigator Email
zuzana.bouckova@globalaes.com
Contact Person Name
Zuzana Kalciková Boucková
Contact Person Email
zuzana.bouckova@globalaes.com
Site Name
Pneumologie Varnsdorf s.r.o.
Principal Investigator Name
Milan Sklenar
Principal Investigator Email
milansklenar@seznam.cz
Contact Person Name
Milan Sklenar
Contact Person Email
milansklenar@seznam.cz
Site Name
Plicni ambulance Kralupy s.r.o.
Principal Investigator Name
Otakar Hokynár
Principal Investigator Email
hokynar.plicni.amb@seznam.cz
Contact Person Name
Otakar Hokynár
Contact Person Email
hokynar.plicni.amb@seznam.cz
Site Name
MediTrial s.r.o.
Principal Investigator Name
Petr Kopecky
Principal Investigator Email
kopir@post.cz
Contact Person Name
Petr Kopecky
Contact Person Email
kopir@post.cz

Bulgaria

Earliest CTIS Part Ii Submission Date
13-11-2025
Latest Decision Or Authorization Date
29-01-2026
Processing Time Days
77
Number Of Sites
12
Number Of Participants
41

Sites

Site Name
Multiprofile Hospital For Active Treatment Pazardzik AD
Department Name
Department of Pneumology and Phthisiatrics
Principal Investigator Name
Kostadinka Sotirova
Principal Investigator Email
k.sotirova.dm@abv.bg
Contact Person Name
Kostadinka Sotirova
Contact Person Email
k.sotirova.dm@abv.bg
Site Name
Medical Centre Pratia Clinic EOOD
Principal Investigator Name
Mihail Kirov
Principal Investigator Email
dr.mihail.kirov@gmail.com
Contact Person Name
Mihail Kirov
Contact Person Email
dr.mihail.kirov@gmail.com
Site Name
University First multiprofile hospital for active treatment Sofia St. Joan Krastitel EAD
Department Name
Clinic of Internal Medicine, Third Division of Internal Medicine at the Clinic of Internal Medicine
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
Diagnostics And Consultation Center Convex Ltd.
Principal Investigator Name
Georgi Hinkov Stoykov
Principal Investigator Email
drhinkov@abv.bg
Contact Person Name
Georgi Hinkov Stoykov
Contact Person Email
drhinkov@abv.bg
Site Name
Multiprofile Hospital For Active Treatment Knyaginya Klementina Sofia EAD
Department Name
Department of Pneumology and phthisiatrics
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
Diagnostics And Consultation Center Convex Ltd. (additional site)
Principal Investigator Name
Mariya Todorova
Principal Investigator Email
mtodorova_medconsult@abv.bg
Contact Person Name
Mariya Todorova
Contact Person Email
mtodorova_medconsult@abv.bg
Site Name
Multi-Profile Hospital For Active Treatment Dr. Stamen Iliev AD
Department Name
Department of Pneumology and Phthisiatrics
Principal Investigator Name
Lidia Nikolcheva-Todorova
Principal Investigator Email
dr.lnikolcheva@gmail.com
Contact Person Name
Lidia Nikolcheva-Todorova
Contact Person Email
dr.lnikolcheva@gmail.com
Site Name
Medical Center Hera EOOD (Montana)
Principal Investigator Name
Vanko Vankov
Principal Investigator Email
vanko.vankov@heraclinics.com
Contact Person Name
Vanko Vankov
Contact Person Email
vanko.vankov@heraclinics.com
Site Name
Specialized Hospital For Active Treatment Of Pneumo-Phthisiatric Diseases Dr. Dimitar Gramatikov-Ruse
Department Name
Department of Pneumology and Phthisiatrics
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
Asclepius Medical Center OOD
Principal Investigator Name
Elena Gyuzeleva
Principal Investigator Email
dr.gyuzeleva@gmail.com
Contact Person Name
Elena Gyuzeleva
Contact Person Email
dr.gyuzeleva@gmail.com
Site Name
Medical Center Hermes Ruse Ltd.
Principal Investigator Name
Nikolay Nikolaev
Principal Investigator Email
nikolay.evgeniev@gmail.com
Contact Person Name
Nikolay Nikolaev
Contact Person Email
nikolay.evgeniev@gmail.com
Site Name
Medical Center Pulmo-2018 EOOD
Principal Investigator Name
Veselin Kalfov
Principal Investigator Email
kalfov@abv.bg
Contact Person Name
Veselin Kalfov
Contact Person Email
kalfov@abv.bg

Romania

Earliest CTIS Part Ii Submission Date
23-10-2025
Latest Decision Or Authorization Date
23-02-2026
Processing Time Days
123
Number Of Sites
9
Number Of Participants
41

Sites

Site Name
Spital De Pneumologie Dr. Lavinia Davidescu S.R.L.
Department Name
Pneumology Department
Principal Investigator Name
Lavinia DAVIDESCU BUTAR
Principal Investigator Email
lavinia.davidescu@yahoo.com
Contact Person Name
Lavinia DAVIDESCU BUTAR
Contact Person Email
lavinia.davidescu@yahoo.com
Site Name
Cabinet Medical de Pneumologie Bogdan Mihai Mincu
Department Name
Pneumology Department
Principal Investigator Name
Bogdan Mihai MINCU
Principal Investigator Email
mbmincu@gmail.com
Contact Person Name
Bogdan Mihai MINCU
Contact Person Email
mbmincu@gmail.com
Site Name
Spitalul De Pneumoftiziologie Bacau
Department Name
Pneumology Department
Principal Investigator Name
Dragos-Gabriel UNGUREANU
Principal Investigator Email
drungureanu@gmail.com
Contact Person Name
Dragos-Gabriel UNGUREANU
Contact Person Email
drungureanu@gmail.com
Site Name
Spitalul Clinic Judetean De Urgenta Bihor
Department Name
Pneumology Department
Principal Investigator Name
Mircea Florin MARTA
Principal Investigator Email
mircea69m@yahoo.com
Contact Person Name
Mircea Florin MARTA
Contact Person Email
mircea69m@yahoo.com
Site Name
Anima Specialty Medical Services S.R.L.
Department Name
Pneumology Department
Principal Investigator Name
Magdalena Aurelia CIOBANU
Principal Investigator Email
magda_ciobanu@yahoo.com
Contact Person Name
Magdalena Aurelia CIOBANU
Contact Person Email
magda_ciobanu@yahoo.com
Site Name
Cabinet Medical Pneumologie Pneumo Bronho Med Dr. Vancea Dorin
Department Name
Pneumology Department
Principal Investigator Name
Ionela IOVAN
Principal Investigator Email
neagoe_ionela@yahoo.com
Contact Person Name
Ionela IOVAN
Contact Person Email
neagoe_ionela@yahoo.com
Site Name
Spitalul Clinic De Pneumoftiziologie Constanta
Department Name
Pneumology 2-Adults
Principal Investigator Name
Ghiultem APTI
Principal Investigator Email
aptighiultem@yahoo.com
Contact Person Name
Ghiultem APTI
Contact Person Email
aptighiultem@yahoo.com
Site Name
Spitalul Clinic De Pneumoftiziologie Leon Daniello
Department Name
Pneumology Department
Principal Investigator Name
Manuela Cosmina MAGDAU
Principal Investigator Email
cmagdau@yahoo.com
Contact Person Name
Manuela Cosmina MAGDAU
Contact Person Email
cmagdau@yahoo.com
Site Name
Spitalul Clinic De Pneumoftiziologie (additional site)
Department Name
Pneumology Department
Principal Investigator Name
Mircea Marta
Principal Investigator Email
mircea69m@yahoo.com
Contact Person Name
Mircea Marta (duplicate site entry may exist)
Contact Person Email
mircea69m@yahoo.com

Italy

Earliest CTIS Part Ii Submission Date
21-08-2025
Latest Decision Or Authorization Date
27-11-2025
Processing Time Days
98
Number Of Sites
10
Number Of Participants
45

Sites

Site Name
Azienda Ospedaliera Policlinico Universitario Tor Vergata
Department Name
U.O.C. Malattie dell’Apparato Respiratorio
Principal Investigator Name
Paola Rogliani
Principal Investigator Email
paola.rogliani@uniroma2.it
Contact Person Name
Paola Rogliani
Contact Person Email
paola.rogliani@uniroma2.it
Site Name
IRCCS Ospedale Policlinico San Martino
Department Name
U.O. Clinica Malattie Respiratorie e Allergologia
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
University Hospital Of Ferrara
Department Name
UO Pneumologia
Principal Investigator Name
Alberto Papi
Principal Investigator Email
alberto.papi@unife.it
Contact Person Name
Alberto Papi
Contact Person Email
alberto.papi@unife.it
Site Name
Universita' Campus Bio-medico Di Roma
Department Name
Dipartimento Medicina Interna
Principal Investigator Name
Simone Scarlata
Principal Investigator Email
s.scarlata@policlinicocampus.it
Contact Person Name
Simone Scarlata
Site Name
Azienda Universitaria Ospedaliera Consorziale Policlinico Bari
Department Name
UOC Malattie dell’apparato Respiratorio
Principal Investigator Name
Giovanna Elisiana Carpagnano
Principal Investigator Email
elisiana.carpagnano@uniba.it
Contact Person Name
Giovanna Elisiana Carpagnano
Contact Person Email
elisiana.carpagnano@uniba.it
Site Name
Azienda Ospedaliero Universitaria Ospedali Riuniti
Department Name
SC Malattie Apparato Respiratorio (MAR)
Principal Investigator Name
Donato Lacedonia
Principal Investigator Email
donato.lacedonia@unifg.it
Contact Person Name
Donato Lacedonia
Contact Person Email
donato.lacedonia@unifg.it
Site Name
Humanitas Mirasole S.p.A.
Department Name
UOC Pneumologia 1
Principal Investigator Name
Anna Stainer
Principal Investigator Email
anna.stainer@hunimed.eu
Contact Person Name
Anna Stainer
Contact Person Email
anna.stainer@hunimed.eu
Site Name
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
Department Name
UOC Pneumologia
Principal Investigator Name
Lucia Spicuzza
Principal Investigator Email
lucia.spicuzza@unict.it
Contact Person Name
Lucia Spicuzza
Contact Person Email
lucia.spicuzza@unict.it
Site Name
Istituti Clinici Scientifici Maugeri S.p.A.
Department Name
U.O. Pneumologia Riabilitativa
Principal Investigator Name
Mauro Maniscalco
Principal Investigator Email
mauro.maniscalco@icsmaugeri.it
Contact Person Name
Mauro Maniscalco
Contact Person Email
mauro.maniscalco@icsmaugeri.it
Site Name
Azienda Ospedaliero-Universitaria Policlinico Umberto I
Department Name
U.O. Pneumologia
Principal Investigator Name
Matteo Bonini
Principal Investigator Email
matteo.bonini@uniroma1.it
Contact Person Name
Matteo Bonini
Contact Person Email
matteo.bonini@uniroma1.it

Sponsor

Primary sponsor

Full Name
Glaxosmithkline Research & Development Limited
Organisation Type
Pharmaceutical company
Country Of Registered Address
United Kingdom

Contract research organisations

Name
PPD Global Ltd.
Responsibilities
codes: 1,10,12,13,2,5,6,7,8
Name
PPD Global Limited
Responsibilities
codes: 1,10,12,13,2,5,6,7,8
Name
Eresearchtechnology Inc.
Responsibilities
ECG, Spirometry, eCoA
Name
Veeva Systems Inc.
Responsibilities
EDC database

Third parties

  • {"country":"United States","full_name":"Veeva Systems Inc.","duties_or_roles":"EDC database","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Greece","full_name":"PPD Global Ltd.","duties_or_roles":"codes: 1,10,12,13,2,5,6,7,8","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Glaxosmithkline LLC","duties_or_roles":"Long term storage of samples","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Scout Clinical","duties_or_roles":"Patient Travel and Reimbursement","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"United States","full_name":"Infinity Biologix LLC","duties_or_roles":"Long term storage of samples","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"ECG, Spirometry, eCoA","organisation_type":"Pharmaceutical company"}
  • {"country":"Belgium","full_name":"PPD Global Central Labs","duties_or_roles":"code: 4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Frontage Laboratories Inc.","duties_or_roles":"code: 4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Glaxosmithkline LLC (sample management)","duties_or_roles":"sample management (code: 4)","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"PPD Global Limited","duties_or_roles":"codes: 1,10,12,13,2,5,6,7,8","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
Depemokimab
Active Substance
DEPEMOKIMAB
Modality
Monoclonal antibody
Routes Of Administration
SUBCUTANEOUS INJECTION
Route
Subcutaneous injection
Authorisation Status
Investigational (IMP12407/00001)
Investigational Product Name
Sterile 0.9% (w/v) sodium chloride solution in single-use PFS
Modality
Other
Investigational Product Name
Novolizer Salbutamol 100 microgrammes/dose, poudre pour inhalation
Active Substance
SALBUTAMOL SULFATE
Modality
Small molecule
Routes Of Administration
INHALATION USE
Route
Inhalation
Authorisation Status
Marketed auxiliary/SoC product (marketing auth BE260793)
Maximum Dose
800 µg daily (maxDailyDoseAmount indicated)
Combination Treatment
Yes

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