Clinical trial • Phase III • Respiratory

DEPEMOKIMAB for Chronic obstructive pulmonary disease

Phase III trial of DEPEMOKIMAB for Chronic obstructive pulmonary disease.

Overview

Trial Therapeutic Area
Respiratory
Trial Disease
Chronic obstructive pulmonary disease
Trial Stage
Phase III
Drug Modality
Monoclonal antibody

Key dates

Initial CTIS Submission Date
27-11-2025
First CTIS Authorization Date
07-04-2026

Trial design

Randomised, arm 1: depemokimab 100 mg (investigational product) administered as add-on to standard of care (depemokimab described as solution for injection, subcutaneous). arm 2: matching placebo i.e. sterile 0.9% (w/v) sodium chloride solution in single-use pfs (matching placebo) plus standard of care. depemokimab dosing schedule described as q26w (every 26 weeks) in the main objective text.-controlled Phase III trial in Germany, Belgium, France and others.

Randomised
Yes
Comparator
Arm 1: depemokimab 100 mg (investigational product) administered as add-on to Standard of Care (depemokimab described as solution for injection, subcutaneous). Arm 2: Matching placebo i.e. Sterile 0.9% (w/v) sodium chloride solution in single-use PFS (matching placebo) plus Standard of Care. Depemokimab dosing schedule described as Q26W (every 26 weeks) in the main objective text.
Target Sample Size
647

Eligibility

Recruits 647 No vulnerable populations selected (isVulnerablePopulationSelected: false). Participants will give informed consent at Screening Visit 1 ("Participants will give informed consent and perform the assessments described in the protocol for Visit 1."). Dedicated informed consent materials for pregnant participants are provided (e.g. documents titled 'L1_224295_Pregnant-Participant_ICF_...') and are available per country..

Vulnerable Population
No vulnerable populations selected (isVulnerablePopulationSelected: false). Participants will give informed consent at Screening Visit 1 ("Participants will give informed consent and perform the assessments described in the protocol for Visit 1."). Dedicated informed consent materials for pregnant participants are provided (e.g. documents titled 'L1_224295_Pregnant-Participant_ICF_...') and are available per country.

Inclusion criteria

  • {"criterion_text":"- Male or eligible female participants\n- Eosinophilic phenotype measured using Blood Eosinophil Count (BEC)\n- Moderate to severe COPD, defined as - A clinically documented history of COPD for at least 1 year - A post-salbutamol Forced expiratory volume in one second (FEV1)/ Forced vital capacity (FVC) ratio of less than (<)0.70 and a post-salbutamol FEV1 greater than (>)30 percent (%) and <80% predicted normal values\n- Elevated risk for exacerbations, defined as - A well-documented history of only 1 moderate COPD exacerbation in the prior 12 months and - The presence of risk factors for future exacerbations/deterioration : ▪ Modified Medical Research Council (mMRC) dyspnea score >= 2 ▪ COPD Assessment Test (CAT) >= 15 ▪ Post-bronchodilator FEV1 < 50% predicted ▪ Chronic bronchitis\n- Smoking status: Current or former cigarette smokers with a history of cigarette smoking of >=10 pack-years at Screening.\n- Dual (Inhaled corticosteroid (ICS)+ Long-acting beta2-adrenergic receptor agonist [LABA] or LABA+ Long-acting muscarinic receptor antagonist [LAMA]) or triple (ICS+LABA+LAMA) inhaler therapy as assessed by the investigator for at least 3 months\n- Body mass index (BMI) >=16 kilograms per square meter (kg/m^2)"}

Exclusion criteria

  • {"criterion_text":"- The Investigator must judge that COPD is the primary diagnosis accounting for the clinical manifestations of lung disease, and clinical manifestations of lung disease where primary diagnosis is not COPD are excluded - Participants with a current or prior physician diagnosis of asthma - Participants with childhood asthma are permitted, provided that childhood asthma has resolved before 18 years of age and has not recurred\n- Other clinically significant lung disease: The Investigator must judge that COPD is the primary diagnosis accounting for the clinical manifestations of the lung disease.\n- COPD severity: Participants with more than one moderate exacerbation or severe exacerbation in the past 12 months prior to Visit 1\n- COPD stability: Participants with pneumonia, COPD exacerbation, or lower respiratory tract infection within the 4 weeks prior to Visit 1\n- Lung resection: Participants with a history of, or plan for lung volume reduction surgery/endobronchial valve procedure\n- Pulmonary rehabilitation: Participants in the acute phase of a pulmonary rehabilitation program within 4 weeks prior to Visit 1\n- Chronic hypercapnia requiring non-invasive positive pressure ventilation (NIPPV) use including Bi-Level Positive Airway Pressure (BiPAP) or Continuous Positive Airway Pressure (CPAP) are excluded\n- Continuous oxygen: Participants requiring oxygen supplementation for COPD"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Annualized rate of moderate/severe exacerbations.","definition_or_measurement_approach":"Annualized rate of moderate/severe exacerbations (no further definition provided in the CTIS metadata)"}

Secondary endpoints

  • {"endpoint_text":"- Time to first moderate/severe exacerbation.","definition_or_measurement_approach":"Time from randomisation to first moderate/severe exacerbation (no further definition provided in the CTIS metadata)"}
  • {"endpoint_text":"- Change from baseline in SGRQ total score (measured using the SGRQ-C) at Week 52.","definition_or_measurement_approach":"Change from baseline in SGRQ total score measured using the SGRQ-C at Week 52"}
  • {"endpoint_text":"- Change from baseline in E-RS: COPD total score at Week 52.","definition_or_measurement_approach":"Change from baseline in E-RS: COPD total score at Week 52"}

Recruitment

Planned Sample Size
647
Recruitment Window Months
42
Consent Approach
Informed consent is obtained from participants at Screening Visit 1 ("Participants will give informed consent and perform the assessments described in the protocol for Visit 1."). Subject information sheets and informed consent forms (Main ICF) are provided per country/language (multiple L1_* ICF documents listed for Germany, Belgium, France, Denmark, Italy, Spain, Netherlands, Poland, Hungary, Romania, Greece, Bulgaria etc.). There are dedicated ICFs for optional genetic research, optional PK sub-studies and for pregnant participants (documents titled e.g. 'L1_224295_Pregnant-Participant_ICF_...'). The CTIS metadata indicates country/language-specific consent documents but does not list details of assent procedures for minors (no paediatric populations selected).

Methods

  • Clinic-based recruitment using printed materials: doctor letters sent to clinicians (Doctor Letter) to inform physicians and facilitate referral of eligible COPD patients (documents present for multiple countries).
  • Patient-facing printed recruitment: flyers, recruitment brochures and flipcharts placed in clinical sites to inform potential participants (country-specific materials available).
  • Patient letters and appointment cards: targeted invitation/appointment materials to patients (Appointment Card, Patient Letter) to arrange screening visits at clinical sites.
  • Welcome guides and recruitment brochures provided to interested participants at sites to explain study participation and next steps.
  • Site staff outreach: site-level recruitment materials and flipcharts to be used by site study teams (materials present per-country in Part II recruitment documents).

Geography

Total Number Of Sites
79
Total Number Of Participants
549

Germany

Earliest CTIS Part Ii Submission Date
23-01-2026
Latest Decision Or Authorization Date
10-04-2026
Processing Time Days
77
Number Of Sites
19
Number Of Participants
107

Sites

Site Name
Velocity Clinical Research Germany GmbH
Principal Investigator Name
Henrik Watz
Principal Investigator Email
hwatz@velocityclinical.com
Contact Person Name
Henrik Watz
Contact Person Email
hwatz@velocityclinical.com
Site Name
Praxis an der Oper
Principal Investigator Name
Thomas Lienert
Principal Investigator Email
thomas.lienert@praxisanderoper.org
Contact Person Name
Thomas Lienert
Site Name
Framol-Med GmbH
Principal Investigator Name
Marc Höffgen
Principal Investigator Email
hoeffgen@lungenpraxis-rheine.de
Contact Person Name
Marc Höffgen
Site Name
Universitaetsklinikum Essen AöR
Principal Investigator Name
Sivagurunathan Sutharsan
Principal Investigator Email
sivagurunathan.sutharsan@rlk.uk-essen.de
Contact Person Name
Sivagurunathan Sutharsan
Site Name
KPPK GmbH
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
Petrus-Krankenhaus
Department Name
Pneumologie, Allergologie, Schlaf- und Intensivmedizin
Principal Investigator Name
Sven Stieglitz
Principal Investigator Email
sven.stieglitz@cellitinnen.de
Contact Person Name
Sven Stieglitz
Contact Person Email
sven.stieglitz@cellitinnen.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
RCMS / Lungenpraxis Hohenzollerndamm
Department Name
Research Center for Medical Studies (RCMS)
Principal Investigator Name
Björn Martens
Contact Person Name
Björn Martens
Site Name
IKF Pneumologie GmbH & Co. KG
Department Name
Institut für klinische Forschung Pneumologie
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
IKF Pneumologie GmbH & Co. KG
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
Zentrale für die Koordination von Studien und Vorträgen der Elbpneumologie
Principal Investigator Name
Sven Philip Aries
Principal Investigator Email
aries@Elbpneumologie.de
Contact Person Name
Sven Philip Aries
Contact Person Email
aries@Elbpneumologie.de
Site Name
SLK-Kliniken Heilbronn GmbH
Principal Investigator Name
Biljana Joves
Principal Investigator Email
biljana.joves@slk-kliniken.de
Contact Person Name
Biljana Joves
Contact Person Email
biljana.joves@slk-kliniken.de
Site Name
Thoraxklinik Heidelberg gGmbH
Department Name
Studienzentrum ThoraxKliPS
Principal Investigator Name
Frederik Trinkmann
Contact Person Name
Frederik Trinkmann
Site Name
Studienzentrum Dr. Keller
Principal Investigator Name
Claus Keller
Principal Investigator Email
ckeller-studien@praxis-ckeller.de
Contact Person Name
Claus Keller
Site Name
Berufsausuebungsgemeinschaft Bag Prof. Dr. Med Gerhard Hoheisel Dr. Med Andreas Bonitz GbR
Principal Investigator Name
Gerhard Hoheisel
Contact Person Name
Gerhard Hoheisel
Site Name
Universitaetsklinikum Bonn AöR
Department Name
Medizinische Klinik und Poliklinik II
Principal Investigator Name
Dirk Skowasch
Principal Investigator Email
dirk.skowasch@ukbonn.de
Contact Person Name
Dirk Skowasch
Contact Person Email
dirk.skowasch@ukbonn.de
Site Name
Universitaetsklinikum Giessen und Marburg GmbH
Principal Investigator Name
Gernot Rohde
Principal Investigator Email
rohdeg@staff.uni-marburg.de
Contact Person Name
Gernot Rohde
Contact Person Email
rohdeg@staff.uni-marburg.de
Site Name
neumologisches Studienzentrum München-West
Principal Investigator Name
Rainald Fischer
Principal Investigator Email
rainald.fischer@gmail.com
Contact Person Name
Rainald Fischer
Contact Person Email
rainald.fischer@gmail.com
Site Name
Clinical Studies Pankow Ishak Teber
Department Name
Lungenpraxis Pankow
Principal Investigator Name
Ishak Teber
Principal Investigator Email
i.teber@gmx.de
Contact Person Name
Ishak Teber
Contact Person Email
i.teber@gmx.de

Belgium

Earliest CTIS Part Ii Submission Date
06-03-2026
Latest Decision Or Authorization Date
07-04-2026
Processing Time Days
32
Number Of Sites
3
Number Of Participants
12

Sites

Site Name
Algemeen Ziekenhuis Groeninge
Department Name
Pneumology
Principal Investigator Name
Mathias Leys
Principal Investigator Email
mathias.leys@azgroeninge.be
Contact Person Name
Mathias Leys
Contact Person Email
mathias.leys@azgroeninge.be
Site Name
UZ Leuven
Department Name
Pneumology
Principal Investigator Name
Wim Janssens
Principal Investigator Email
wim.janssens@uzleuven.be
Contact Person Name
Wim Janssens
Contact Person Email
wim.janssens@uzleuven.be
Site Name
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
Department Name
Pneumology
Principal Investigator Name
Eric Marchand
Principal Investigator Email
eric.marchand@chuuclnamur.uclouvain.be
Contact Person Name
Eric Marchand

France

Earliest CTIS Part Ii Submission Date
21-01-2026
Latest Decision Or Authorization Date
08-04-2026
Processing Time Days
77
Number Of Sites
8
Number Of Participants
46

Sites

Site Name
Groupe Hospitalier Du Havre
Department Name
Pulmonology
Principal Investigator Name
Bouchra LAMIA
Principal Investigator Email
Bouchra.lamia@ch-havre.fr
Contact Person Name
Bouchra LAMIA
Contact Person Email
Bouchra.lamia@ch-havre.fr
Site Name
Centre Hospitalier Universitaire Amiens Picardie
Department Name
Respiratory diseases
Principal Investigator Name
Claire ANDREJAK
Principal Investigator Email
andrejak.claire@chu-amiens.fr
Contact Person Name
Claire ANDREJAK
Contact Person Email
andrejak.claire@chu-amiens.fr
Site Name
Centre Hospitalier Universitaire De Caen Normandie
Department Name
Pulmonology
Principal Investigator Name
Aurélien JUSTET
Principal Investigator Email
justet-a@chu-caen.fr
Contact Person Name
Aurélien JUSTET
Contact Person Email
justet-a@chu-caen.fr
Site Name
CHRU De Nancy
Department Name
Pulmonology
Principal Investigator Name
Bruno RIBEIRO BAPTISTA
Principal Investigator Email
b.ribeiro-baptista@chru-nancy.fr
Contact Person Name
Bruno RIBEIRO BAPTISTA
Site Name
Centre Hospitalier Universitaire Grenoble Alpes
Department Name
Pulmonology
Principal Investigator Name
Bruno DEGANO
Principal Investigator Email
bdegano@chu-grenoble.fr
Contact Person Name
Bruno DEGANO
Contact Person Email
bdegano@chu-grenoble.fr
Site Name
Centre Hospitalier Du Pays D Aix Centre Hospitalier Intercommunal Aix-Pertuis
Department Name
Respiratory Diseases
Principal Investigator Name
Youssef TRIGUI
Principal Investigator Email
ytrigui@ch-aix.fr
Contact Person Name
Youssef TRIGUI
Contact Person Email
ytrigui@ch-aix.fr
Site Name
Centre Hospitalier Universitaire De Nimes
Department Name
Pulmonology
Principal Investigator Name
Sylvain DRONEAU
Principal Investigator Email
sylvain.droneau@chu-nimes.fr
Contact Person Name
Sylvain DRONEAU
Contact Person Email
sylvain.droneau@chu-nimes.fr
Site Name
Centre Hospitalier Universitaire De Nice
Department Name
Pulmonology, Thoracic oncology and critical care
Principal Investigator Name
Charles-Hugo MARQUETTE
Principal Investigator Email
marquette.c@chu-nice.fr
Contact Person Name
Charles-Hugo MARQUETTE
Contact Person Email
marquette.c@chu-nice.fr

Denmark

Earliest CTIS Part Ii Submission Date
25-03-2026
Latest Decision Or Authorization Date
07-04-2026
Processing Time Days
13
Number Of Sites
4
Number Of Participants
18

Sites

Site Name
Lillebaelt Hospital
Department Name
Lungemedicinsk afdeling
Principal Investigator Name
Ole Hilberg
Principal Investigator Email
Ole.hilberg@rsyd.dk
Contact Person Name
Ole Hilberg
Contact Person Email
Ole.hilberg@rsyd.dk
Site Name
Aalborg University Hospital
Department Name
Lungemedicinsk afdeling
Principal Investigator Name
Ulla Møller Weinreich
Principal Investigator Email
ulw@rn.dk
Contact Person Name
Ulla Møller Weinreich
Contact Person Email
ulw@rn.dk
Site Name
Region Hovedstaden
Department Name
Lungemedicinsk afdeling
Principal Investigator Name
Charlotte Suppli Ulrik
Principal Investigator Email
charlotte.suppli.ulrik@regionh
Contact Person Name
Charlotte Suppli Ulrik
Contact Person Email
charlotte.suppli.ulrik@regionh
Site Name
Region Sjaelland
Department Name
Medicinsk afdeling
Principal Investigator Name
Christian Meyer
Principal Investigator Email
cnm@regionsjaelland.dk
Contact Person Name
Christian Meyer
Contact Person Email
cnm@regionsjaelland.dk

Italy

Earliest CTIS Part Ii Submission Date
25-03-2026
Latest Decision Or Authorization Date
13-04-2026
Processing Time Days
19
Number Of Sites
6
Number Of Participants
31

Sites

Site Name
Azienda Ospedaliera Dei Colli
Department Name
Clinica Pneumoloigica "L. Vanvitelli"- Dipartimento di Pneumologia e delle Specialità Mediche
Principal Investigator Name
Fabio PERROTTA
Principal Investigator Email
fabio.perrotta@unicampania.it
Contact Person Name
Fabio PERROTTA
Contact Person Email
fabio.perrotta@unicampania.it
Site Name
Azienda Sanitaria Locale Di Taranto
Department Name
Pneumologia
Principal Investigator Name
Andrea NICO
Principal Investigator Email
andrea.nico@asl.taranto.it
Contact Person Name
Andrea NICO
Contact Person Email
andrea.nico@asl.taranto.it
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
UOSD Allergologia - Dipartimento di Scienze Mediche e Chirurgiche
Principal Investigator Name
Cristiano CARUSO
Principal Investigator Email
cristiano.caruso@policlinicogemelli.it
Contact Person Name
Cristiano CARUSO
Site Name
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Department Name
U.O.C. Pneumologia
Principal Investigator Name
Michela BEZZI
Principal Investigator Email
drmichela.bezzi@gmail.com
Contact Person Name
Michela BEZZI
Contact Person Email
drmichela.bezzi@gmail.com
Site Name
Azienda Ospedaliera di Padova
Department Name
U.O.C. di Fisiopatologia Respiratoria
Principal Investigator Name
Andrea VIANELLO
Principal Investigator Email
andrea.vianello@aopd.veneto.it
Contact Person Name
Andrea VIANELLO
Contact Person Email
andrea.vianello@aopd.veneto.it
Site Name
University Hospital Of Ferrara
Department Name
Pneumologia
Principal Investigator Name
Alberto PAPI
Principal Investigator Email
ppa@unife.it
Contact Person Name
Alberto PAPI
Contact Person Email
ppa@unife.it

Spain

Earliest CTIS Part Ii Submission Date
22-01-2026
Latest Decision Or Authorization Date
09-04-2026
Processing Time Days
77
Number Of Sites
10
Number Of Participants
59

Sites

Site Name
Hospital Vithas Xanit Internacional
Department Name
Pneumology
Principal Investigator Name
Gustavo de Luiz Martínez
Principal Investigator Email
neumologix@yahoo.com
Contact Person Name
Gustavo de Luiz Martínez
Contact Person Email
neumologix@yahoo.com
Site Name
Hospital Universitario Virgen De La Victoria
Department Name
Pneumology
Principal Investigator Name
José Luís Velasco Garrido
Principal Investigator Email
jlvelascogarrido@hotmail.com
Contact Person Name
José Luís Velasco Garrido
Contact Person Email
jlvelascogarrido@hotmail.com
Site Name
Hospital Universitario Rio Hortega
Department Name
Pneumology
Principal Investigator Name
Graciela López Muñiz
Principal Investigator Email
glopezm@saludcastillayleon.es
Contact Person Name
Graciela López Muñiz
Contact Person Email
glopezm@saludcastillayleon.es
Site Name
Hospital La Milagrosa S.A.
Department Name
Pneumology
Principal Investigator Name
Walther Ivan Giron Matute
Principal Investigator Email
gironmw@ext.vithas.es
Contact Person Name
Walther Ivan Giron Matute
Contact Person Email
gironmw@ext.vithas.es
Site Name
Pectus Respiratory Health S.L.
Department Name
Pneumology
Principal Investigator Name
Juan Roldán Sánchez
Principal Investigator Email
juan.roldan@giromedinstitute.com
Contact Person Name
Juan Roldán Sánchez
Site Name
Hospital Universitario Fundacion Jimenez Diaz
Department Name
Pneumology
Principal Investigator Name
Carolina María Gotera Rivera
Principal Investigator Email
carolina.gotera@fjd.es
Contact Person Name
Carolina María Gotera Rivera
Contact Person Email
carolina.gotera@fjd.es
Site Name
Hospital Universitari De Santa Maria
Department Name
Pneumology
Principal Investigator Name
Jessica Gonzalez Gutierrez
Principal Investigator Email
jgonzalezgutierrez88@gmail.com
Contact Person Name
Jessica Gonzalez Gutierrez
Contact Person Email
jgonzalezgutierrez88@gmail.com
Site Name
Hospital Universitario De La Ribera
Department Name
Pneumology
Principal Investigator Name
Elsa Naval Sendra
Principal Investigator Email
naval_els@gva.es
Contact Person Name
Elsa Naval Sendra
Contact Person Email
naval_els@gva.es
Site Name
Hospital Universitario Regional De Malaga
Department Name
Pneumology
Principal Investigator Name
Esperanza Doña Díaz
Principal Investigator Email
esperuli@gmail.com
Contact Person Name
Esperanza Doña Díaz
Contact Person Email
esperuli@gmail.com
Site Name
University Hospital Son Espases
Department Name
Pneumology
Principal Investigator Name
Francisco de Borja García-Cosío Piqueras
Principal Investigator Email
borja.cosio@ssib.es
Contact Person Name
Francisco de Borja García-Cosío Piqueras
Contact Person Email
borja.cosio@ssib.es

Netherlands

Earliest CTIS Part Ii Submission Date
06-03-2026
Latest Decision Or Authorization Date
08-04-2026
Processing Time Days
33
Number Of Sites
2
Number Of Participants
13

Sites

Site Name
Amphia Hospital
Department Name
Respiratory Deparment
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
Site Name
Medisch Spectrum Twente
Department Name
Respiratory Deparment
Principal Investigator Name
Wendy Moeskops- van Beurden
Principal Investigator Email
W.vanBeurden@mst.nl
Contact Person Name
Wendy Moeskops- van Beurden
Contact Person Email
W.vanBeurden@mst.nl

Poland

Earliest CTIS Part Ii Submission Date
24-03-2026
Latest Decision Or Authorization Date
09-04-2026
Processing Time Days
16
Number Of Sites
6
Number Of Participants
39

Sites

Site Name
Santa Sp. z o.o.
Department Name
Santa Familia PTG Łódź
Principal Investigator Name
Mariola Jędrzejczak
Principal Investigator Email
mariola.jedrzejczak@ptg-network.com
Contact Person Name
Mariola Jędrzejczak
Site Name
PULMAG s.c.
Principal Investigator Name
Grzegorz Gąsior
Principal Investigator Email
grzegorz.g15@wp.pl
Contact Person Name
Grzegorz Gąsior
Contact Person Email
grzegorz.g15@wp.pl
Site Name
Prywatny Gabinet Lekarski Małgorzata Pawlukiewicz
Principal Investigator Name
Małgorzata Pawlukiewicz
Principal Investigator Email
mpawlu@onet.eu
Contact Person Name
Małgorzata Pawlukiewicz
Contact Person Email
mpawlu@onet.eu
Site Name
Centrum Medycyny Oddechowej Mroz Sp. j.
Principal Investigator Name
Robert Mróz
Principal Investigator Email
robert.mroz@cmo-med.pl
Contact Person Name
Robert Mróz
Contact Person Email
robert.mroz@cmo-med.pl
Site Name
Specjalistyczna Przychodnia Lekarska Alergo Med Sp. z o.o.
Principal Investigator Name
Danuta Mądra-Rogacka
Principal Investigator Email
dmadrarogacka@gmail.com
Contact Person Name
Danuta Mądra-Rogacka
Contact Person Email
dmadrarogacka@gmail.com
Site Name
Other (local site)

Hungary

Earliest CTIS Part Ii Submission Date
05-02-2026
Latest Decision Or Authorization Date
13-04-2026
Processing Time Days
67
Number Of Sites
3
Number Of Participants
22

Sites

Site Name
Omnimodus Elixir Kft.
Principal Investigator Name
Erika Unger
Principal Investigator Email
ungerstudy@gmail.com
Contact Person Name
Erika Unger
Contact Person Email
ungerstudy@gmail.com
Site Name
Hajdunanas Varosi Onkormanyzat
Department Name
Pulmonology
Principal Investigator Name
Aniko Kurucz
Principal Investigator Email
kuruczaniko7@gmail.com
Contact Person Name
Aniko Kurucz
Contact Person Email
kuruczaniko7@gmail.com
Site 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

Romania

Earliest CTIS Part Ii Submission Date
19-02-2026
Latest Decision Or Authorization Date
14-04-2026
Processing Time Days
54
Number Of Sites
3
Number Of Participants
18

Sites

Site Name
Cabinet Medical Pneumologie Pneumo Bronho Med Dr. Vancea Dorin
Department Name
Pneumologie
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
Neoclinic Concept S.R.L.
Department Name
Pneumologie
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
Delta Health Care S.R.L.
Department Name
Cabinetul de Studii Clinice (Etajul 2)
Principal Investigator Name
Veronica-Florentina Surlea
Principal Investigator Email
drsiteavuvera@yahoo.com
Contact Person Name
Veronica-Florentina Surlea
Contact Person Email
drsiteavuvera@yahoo.com

Greece

Earliest CTIS Part Ii Submission Date
29-12-2025
Latest Decision Or Authorization Date
08-04-2026
Processing Time Days
100
Number Of Sites
6
Number Of Participants
76

Sites

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
Athens Medical Center S.A. (Paleo Faliro)
Department Name
Respiratory department
Principal Investigator Name
Elpiniki Georgatou-Papageorgiou
Principal Investigator Email
nikipapageo@gmail.com
Contact Person Name
Elpiniki Georgatou-Papageorgiou
Contact Person Email
nikipapageo@gmail.com
Site Name
Athens Medical Center S.A. (Maroussi)
Department Name
Respiratory 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
University Pulmonary 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
Thermi Clinic S.A.
Department Name
Department of Pathology
Principal Investigator Name
Stavros Tryfon
Principal Investigator Email
stavrostryfon@yahoo.gr
Contact Person Name
Stavros Tryfon
Contact Person Email
stavrostryfon@yahoo.gr
Site Name
University General Hospital Of Ioannina
Department Name
Respiratory Medicine
Principal Investigator Name
Konstantinos Kostikas
Principal Investigator Email
ktkostikas@gmail.com
Contact Person Name
Konstantinos Kostikas
Contact Person Email
ktkostikas@gmail.com

Bulgaria

Earliest CTIS Part Ii Submission Date
05-03-2026
Latest Decision Or Authorization Date
09-04-2026
Processing Time Days
35
Number Of Sites
9
Number Of Participants
108

Sites

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
Medical Center Medconsult Pleven OOD
Department Name
Pneumology and Phthisiology
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
Lidiya Nikolcheva-Todorova
Principal Investigator Email
dr.lnikolcheva@gmail.com
Contact Person Name
Lidiya Nikolcheva-Todorova
Contact Person Email
dr.lnikolcheva@gmail.com
Site Name
Medical center NeoGeneX Ltd.
Principal Investigator Name
Radostina Cherneva
Principal Investigator Email
cherneva_radost@yahoo.com
Contact Person Name
Radostina Cherneva
Contact Person Email
cherneva_radost@yahoo.com
Site Name
Medical Center Pulmovision Ltd.
Principal Investigator Name
Miroslav Mihaylov
Principal Investigator Email
miroslavmihailov@abv.bg
Contact Person Name
Miroslav Mihaylov
Contact Person Email
miroslavmihailov@abv.bg
Site Name
Medical Center Hera EOOD
Principal Investigator Name
Kiril Palaveev
Principal Investigator Email
kiril.palaveev@heraclinics.com
Contact Person Name
Kiril Palaveev
Contact Person Email
kiril.palaveev@heraclinics.com
Site Name
University Multiprofile Hospital For Active Treatment And Emergency Medicine N I Pirogov
Department Name
Clinic of Internal Diseases
Principal Investigator Name
Diana Slaveva Mladenova
Principal Investigator Email
diana.slaveva@abv.bg
Contact Person Name
Diana Slaveva Mladenova
Contact Person Email
diana.slaveva@abv.bg
Site Name
Multiprofile Hospital For Active Treatment Knyaginya Klementina Sofia EAD
Department Name
Department of Pneumology and Phthisiatrics,
Principal Investigator Name
Kalin Alexandrov
Principal Investigator Email
k_alexandrov@abv.bg
Contact Person Name
Kalin Alexandrov
Contact Person Email
k_alexandrov@abv.bg
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

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 Limited
Responsibilities
sponsorDuties codes: [1,10,12,13,2,5,6,7,8]
Name
PPD Global Ltd.
Responsibilities
sponsorDuties codes: [1,10,12,13,2,5,6,7,8] (country-specific entity)
Name
PPD Global Central Labs
Responsibilities
Central laboratory activities (sponsorDuties code: [4])

Third parties

  • {"country":"United Kingdom","full_name":"PPD Global Limited","duties_or_roles":"sponsorDuties 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":"Frontage Laboratories Inc.","duties_or_roles":"sponsorDuties code: [4]","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":"Veeva Systems Inc.","duties_or_roles":"EDC database","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Greece","full_name":"PPD Global Ltd.","duties_or_roles":"sponsorDuties codes: [1,10,12,13,2,5,6,7,8]","organisation_type":"Pharmaceutical company"}
  • {"country":"Belgium","full_name":"PPD Global Central Labs","duties_or_roles":"sponsorDuties code: [4]","organisation_type":"Pharmaceutical company"}
  • {"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":"Glaxosmithkline LLC (sample management)","duties_or_roles":"sponsorDuties code: [4]","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"ECG, Spirometry, eCoA","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 (MIA number IMP12407/00001)
Starting Dose
100 mg
Frequency
Every 26 weeks (Q26W)
Maximum Dose
600 mg (max total as per product data)
Investigational Product Name
Sterile 0.9% (w/v) sodium chloride solution in single-use PFS
Modality
Other
Authorisation Status
N/A (placebo)
Combination Treatment
Yes

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