Clinical trial • Phase IV • Respiratory

DUPILUMAB for Chronic obstructive pulmonary disease

Phase IV trial of DUPILUMAB for Chronic obstructive pulmonary disease.

Overview

Trial Therapeutic Area
Respiratory
Trial Disease
Chronic obstructive pulmonary disease
Trial Stage
Phase IV
Drug Modality
Monoclonal antibody|Small molecule

Key dates

Initial CTIS Submission Date
06-06-2025
First CTIS Authorization Date
29-09-2025

Trial design

Randomised, matched placebo for test product (matched placebo for dupilumab); dose and schedule not specified in available data. background therapy: triple therapy (ics + laba + lama) required/stable; reliever medication: ventolin evohaler 100 micrograms as auxiliary/reliever.-controlled Phase IV trial in Austria, Denmark, France and others.

Randomised
Yes
Comparator
matched placebo for test product (matched placebo for Dupilumab); dose and schedule not specified in available data. Background therapy: triple therapy (ICS + LABA + LAMA) required/stable; reliever medication: Ventolin Evohaler 100 micrograms as auxiliary/reliever.
Target Sample Size
252
Trial Duration For Participant
168

Eligibility

Recruits 252 adults.

Inclusion criteria

  • {"criterion_text":"- Current or former smokers with a smoking history of ≥10 pack-years\n- Moderate-to-severe COPD (post-BD FEV1/FVC ratio <0.70 and post- BD FEV1 % predicted >30% and ≤70%)\n- Medical Research Council Dyspnea Scale grade ≥2 or COPD assessment test (CAT) score ≥10\n- Global Initiative for Chronic Obstructive Lung Disease (GOLD) category E, Frequent or severe exacerbations\n- Background triple therapy (ICS + LABA + LAMA) for 3 months before randomization with a stable dose of medication for ≥1 month before Visit 1; dual therapy (LABA + LAMA) allowed if ICS is contraindicated\n- Evidence of Type 2 inflammation: Participants with blood eosinophils ≥300 cells/μL at screening or with blood eosinophils ≥150 cells/μL at Visit 1 (screening) and with a history of blood eosinophils ≥300 cells/μL within the past year during stable state (non-exacerbation).\n- Mucus score cutoff of ≥3"}

Exclusion criteria

  • {"criterion_text":"- A current diagnosis of asthma according to the Global Initiative for Asthma diagnostic (GINA) guidelines, or documented history of asthma\n- Significant pulmonary disease other than COPD (eg, lung fibrosis, sarcoidosis, interstitial lung disease, pulmonary hypertension, bronchiectasis, Churg-Strauss Syndrome) or another diagnosed pulmonary or systemic disease associated with elevated peripheral eosinophil counts\n- Treatment with oxygen >4.0 L/min for ≥8 hours/day\n- Respiratory tract infection within 4 weeks before screening, or during the screening period\n- Diagnosis of α-1 anti-trypsin deficiency\n- Any biologic therapy (including experimental treatments and dupilumab)\n- Participants on treatment with mucolytics unless on stable therapy for >6 months"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Change from baseline to Week 24 in global lung mucus score (UCSF mucus scoring)","definition_or_measurement_approach":"Change from baseline to Week 24 measured using the global lung mucus score (UCSF mucus scoring)."}

Secondary endpoints

  • {"endpoint_text":"- Change from baseline to Week 24 in mucus volume for global lung by High-resolution Computed Tomography (HRCT)","definition_or_measurement_approach":"Change from baseline to Week 24 in mucus volume measured by HRCT."}
  • {"endpoint_text":"- Change from baseline to Week 24 in trimmed distal airway wall thickness at TLC by HRCT","definition_or_measurement_approach":"Change from baseline to Week 24 in trimmed distal airway wall thickness at TLC measured by HRCT."}
  • {"endpoint_text":"- Change from baseline to Week 24 in airway resistance from R5 to R20 measured by Forced Oscillation Technique (FOT)","definition_or_measurement_approach":"Change from baseline to Week 24 in airway resistance (R5 to R20) measured by Forced Oscillation Technique (FOT)."}
  • {"endpoint_text":"- Change from baseline to Week 24 in Reactance area (AX) measured by FOT","definition_or_measurement_approach":"Change from baseline to Week 24 in reactance area (AX) measured by FOT."}
  • {"endpoint_text":"- Incidence of Treatment-Emergent Adverse Event (TEAE), Serious Adverse Event (SAE), and Adverse Event of Special Interest (AESI) including potentially clinically significant abnormalities","definition_or_measurement_approach":"Incidence of TEAEs, SAEs and AESIs including potentially clinically significant abnormalities as collected during the study."}

Recruitment

Planned Sample Size
252
Recruitment Window Months
38
Consent Approach
Informed consent is required. Subject information and informed consent form (L1) documents are provided in multiple country-specific languages (examples in the document list include English, German, French, Dutch, Hungarian, Italian, Polish, Spanish, Swedish). No explicit details on assent or age-specific consent processes are provided in the available CTIS data.

Geography

Total Number Of Sites
40
Total Number Of Participants
184

Austria

Earliest CTIS Part Ii Submission Date
07-08-2025
Latest Decision Or Authorization Date
06-10-2025
Processing Time Days
60
Number Of Sites
3
Number Of Participants
24

Sites

Site Name
Medizinische Universitaet Innsbruck
Department Name
Medizinische Universitaet Innsbruck
Principal Investigator Name
Judith Loeffler-Ragg
Principal Investigator Email
judith.loeffler-ragg@tirol-kliniken.at
Contact Person Name
Judith Loeffler-Ragg
Site Name
Kepler Universitaetsklinikum GmbH
Department Name
Med Campus III - Universitätsklinik für Kinder- und Jugendheilkunde
Principal Investigator Name
Andreas Horner
Principal Investigator Email
Andreas.Horner@kepleruniklinikum.at
Contact Person Name
Andreas Horner
Site Name
Stadt Wien Wiener Gesundheitsverbund
Department Name
Interne Abteilung Fur Lungenerkrankungen
Principal Investigator Name
Marie-Kathrin Breyer
Principal Investigator Email
marie-kathrin.breyer@gesundheitsverbund.at
Contact Person Name
Marie-Kathrin Breyer

Denmark

Earliest CTIS Part Ii Submission Date
05-09-2025
Latest Decision Or Authorization Date
30-09-2025
Processing Time Days
25
Number Of Sites
2
Number Of Participants
8

Sites

Site Name
Lillebaelt Hospital
Department Name
Vejle Sygehus Lungemedicinsk Ambulatorium A650
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
Aalborg Sygehus Nord Department of Respiratory Diseases and the Clinical Institute
Principal Investigator Name
Ulla Møller
Principal Investigator Email
ulw@rn.dk
Contact Person Name
Ulla Møller
Contact Person Email
ulw@rn.dk

France

Earliest CTIS Part Ii Submission Date
29-07-2025
Latest Decision Or Authorization Date
29-09-2025
Processing Time Days
62
Number Of Sites
9
Number Of Participants
32

Sites

Site Name
Hospices Civils De Lyon
Department Name
Hôpital de 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
Centre Hospitalier Universitaire De Lille
Department Name
CHU Lille - Institut Coeur Poumon
Principal Investigator Name
Thierry Perez
Principal Investigator Email
thierry.perez@chu-lille.fr
Contact Person Name
Thierry Perez
Contact Person Email
thierry.perez@chu-lille.fr
Site Name
Centre Hospitalier Universitaire Reims
Department Name
Hôpital Robert Debré Service des 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 Regional Et Universitaire De Brest
Department Name
Centre Hospitalier Régional Universitaire de Brest - Hôpital de la Cavale Blanche
Principal Investigator Name
Christophe Gut-Gobert
Principal Investigator Email
christophe.gut-gobert@chu-brest.fr
Contact Person Name
Christophe Gut-Gobert
Site Name
Centre Hospitalier Regional De Marseille
Department Name
Assistance Publique Hôpitaux de Marseille - Hôpital Nord
Principal Investigator Name
Pascal Chanez
Principal Investigator Email
pascal.chanez@univ-amu.fr
Contact Person Name
Pascal Chanez
Contact Person Email
pascal.chanez@univ-amu.fr
Site Name
Centre Hospitalier Universitaire De Montpellier
Department Name
Service des Maladies Respiratoires
Principal Investigator Name
Arnaud Bourdin
Principal Investigator Email
a-bourdin@chu-montpellier.fr
Contact Person Name
Arnaud Bourdin
Contact Person Email
a-bourdin@chu-montpellier.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
GHU APHP-Sorbonne Université – Pitié-Salpêtrière Pneumologie
Principal Investigator Name
Capucine Morelot-Panzini
Principal Investigator Email
Capucine.morelot@aphp.fr
Contact Person Name
Capucine Morelot-Panzini
Contact Person Email
Capucine.morelot@aphp.fr
Site Name
Centre Hospitalier Universitaire Grenoble Alpes
Department Name
CHU Grenoble Alpes Pneumology
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 Universitaire De Bordeaux
Department Name
Groupe Hospitalier Sud - Hôpital Haut Lévêque
Principal Investigator Name
Maeva Zysman
Principal Investigator Email
maeva.zysman@chu-bordeaux.fr
Contact Person Name
Maeva Zysman
Contact Person Email
maeva.zysman@chu-bordeaux.fr

Germany

Earliest CTIS Part Ii Submission Date
25-08-2025
Latest Decision Or Authorization Date
30-09-2025
Processing Time Days
36
Number Of Sites
3
Number Of Participants
8

Sites

Site Name
Velocity Clinical Research Germany GmbH
Department Name
Velocity Clinical Reasearch - Ahrensburg
Principal Investigator Name
Henrik Watz
Principal Investigator Email
h.watz@pulmoresearch.de
Contact Person Name
Henrik Watz
Contact Person Email
h.watz@pulmoresearch.de
Site Name
IKF Pneumologie GmbH & Co. KG
Department Name
IKF Institut für Klinische Forschung 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
Principal Investigator Name
Matthias Kruell
Principal Investigator Email
kruell@pneumologie-berlin.de
Contact Person Name
Matthias Kruell
Contact Person Email
kruell@pneumologie-berlin.de

Hungary

Earliest CTIS Part Ii Submission Date
29-07-2025
Latest Decision Or Authorization Date
03-10-2025
Processing Time Days
66
Number Of Sites
3
Number Of Participants
16

Sites

Site Name
Crodoctor Kft.
Department Name
Szalay Janos Rendelőintézet Tüdőgyógyászat
Principal Investigator Name
Edina Kurucz
Principal Investigator Email
drkuruczedina@gmail.com
Contact Person Name
Edina Kurucz
Contact Person Email
drkuruczedina@gmail.com
Site Name
Infer-Med Kft.
Department Name
Da Vinci Magánklinika
Principal Investigator Name
Marta Papp
Principal Investigator Email
drpappm@gmail.com
Contact Person Name
Marta Papp
Contact Person Email
drpappm@gmail.com
Site Name
University Of Debrecen
Department Name
Debreceni Egyetem Klinikai Központ
Principal Investigator Name
Ildiko Horvath
Principal Investigator Email
horvath.ildiko@med.unideb.hu
Contact Person Name
Ildiko Horvath
Contact Person Email
horvath.ildiko@med.unideb.hu

Italy

Earliest CTIS Part Ii Submission Date
02-09-2025
Latest Decision Or Authorization Date
01-10-2025
Processing Time Days
29
Number Of Sites
4
Number Of Participants
16

Sites

Site Name
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
Department Name
Azienda Sanitaria Ospedaliera San Luigi Gonzaga
Principal Investigator Name
Fabio Luigi Massimo Ricciardolo
Principal Investigator Email
fabioluigimassimo.ricciardolo@unito.it
Contact Person Name
Fabio Luigi Massimo Ricciardolo
Site Name
University Hospital Of Ferrara
Department Name
Unità Operativa di Pneumologia dell’Azienda Ospedaliero Universitaria di Ferrara
Principal Investigator Name
Alberto Papi
Principal Investigator Email
cemicef@unife.it
Contact Person Name
Alberto Papi
Contact Person Email
cemicef@unife.it
Site Name
Azienda Ospedaliero-Universitaria Senese
Department Name
Azienda Ospedaliera Universitaria Senese​
Principal Investigator Name
Felice Perillo
Principal Investigator Email
felice.perillo@unisi.it
Contact Person Name
Felice Perillo
Contact Person Email
felice.perillo@unisi.it
Site Name
Azienda Unita' Locale Socio Sanitaria N. 2 Marca Trevigiana
Department Name
UOC Pneumologia
Principal Investigator Name
Francesco Menzella
Principal Investigator Email
francesco.menzella@ausl.re.it
Contact Person Name
Francesco Menzella
Contact Person Email
francesco.menzella@ausl.re.it

Spain

Earliest CTIS Part Ii Submission Date
28-08-2025
Latest Decision Or Authorization Date
03-10-2025
Processing Time Days
36
Number Of Sites
5
Number Of Participants
24

Sites

Site Name
Hospital Universitario Central De Asturias
Department Name
Hospital Universitario Central de Asturias
Principal Investigator Name
Marta Iscar Urrutia
Principal Investigator Email
martaiscar@gmail.com
Contact Person Name
Marta Iscar Urrutia
Contact Person Email
martaiscar@gmail.com
Site Name
Hospital Universitario Fundacion Jimenez Diaz
Department Name
Hospital Universitario Fundación Jiménez Díaz
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 Quironsalud Madrid
Department Name
Hospital Universitario Quirón Salud Madrid
Principal Investigator Name
Jose Maria Echave-Sustaeta Maria-Tomé
Principal Investigator Email
jose.echave@quironsalud.es
Contact Person Name
Jose Maria Echave-Sustaeta Maria-Tomé
Contact Person Email
jose.echave@quironsalud.es
Site Name
Pectus Respiratory Health S.L.
Department Name
Pectus Respiratoy Health S.L. (BCN)
Principal Investigator Name
Juan Roldan-Sanchez
Principal Investigator Email
juan.roldan@giromedinstitute.com
Contact Person Name
Juan Roldan-Sanchez
Site Name
Hospital Universitario Marques De Valdecilla
Department Name
Hospital Universitario Marqués de Valdecilla
Principal Investigator Name
Carlos Antonio Amado Diago
Principal Investigator Email
carlosantonio.amado@scsalud.es
Contact Person Name
Carlos Antonio Amado Diago
Contact Person Email
carlosantonio.amado@scsalud.es

Netherlands

Earliest CTIS Part Ii Submission Date
17-09-2025
Latest Decision Or Authorization Date
06-10-2025
Processing Time Days
19
Number Of Sites
5
Number Of Participants
20

Sites

Site Name
Universitair Medisch Centrum Groningen
Department Name
Universitair Medisch Centrum Groningen
Principal Investigator Name
Maarten van den Berge
Principal Investigator Email
m.van.den.berge@umcg.nl
Contact Person Name
Maarten van den Berge
Contact Person Email
m.van.den.berge@umcg.nl
Site Name
Canisius Wilhelmina Ziekenhuis
Department Name
Department of Pulmonary Medicine
Principal Investigator Name
Rob Janssen
Principal Investigator Email
rob.janssen@cwz.nl
Contact Person Name
Rob Janssen
Contact Person Email
rob.janssen@cwz.nl
Site Name
Spaarne Gasthuis Stichting
Department Name
Spaarne Gasthuis, Haarlem Zuid
Principal Investigator Name
Folkert Brijker
Principal Investigator Email
fbrijker@spaarnegasthuis.nl
Contact Person Name
Folkert Brijker
Contact Person Email
fbrijker@spaarnegasthuis.nl
Site Name
Sint Franciscus Vlietland Groep Stichting
Department Name
Franciscus Gasthuis & Vlietland, Locatie Gasthuis
Principal Investigator Name
Yasemin Turk
Principal Investigator Email
Yasemin.turk@franciscus.nl
Contact Person Name
Yasemin Turk
Contact Person Email
Yasemin.turk@franciscus.nl
Site Name
Radboud universitair medisch centrum Stichting
Department Name
Radboud Universitair Medisch Centrum
Principal Investigator Name
Bram Van Den Borst
Principal Investigator Email
Bram.vandenBorst@radboudumc.nl
Contact Person Name
Bram Van Den Borst
Contact Person Email
Bram.vandenBorst@radboudumc.nl

Poland

Earliest CTIS Part Ii Submission Date
29-08-2025
Latest Decision Or Authorization Date
06-10-2025
Processing Time Days
38
Number Of Sites
3
Number Of Participants
20

Sites

Site Name
Centrum Medycyny Oddechowej Mroz Sp. j.
Department Name
Centrum Medycyny Oddechowej Spolka Jawna
Principal Investigator Name
Robert Marek Mroz
Principal Investigator Email
robmroz@wp.pl
Contact Person Name
Robert Marek Mroz
Contact Person Email
robmroz@wp.pl
Site Name
Specjalistyczny Niepubliczny Zaklad Opieki Zdrowotnej Alergologia Plus Osrodek Diagnostyki I Terapii Uczulen
Department Name
Specjalistyczny Niepubliczny Zaklad Opieki Zdrowotnej Alergologia Plus Osrodek Diagnostyki I Terapii
Principal Investigator Name
Michal Springer
Principal Investigator Email
michal.springer.pl@gmail.com
Contact Person Name
Michal Springer
Contact Person Email
michal.springer.pl@gmail.com
Site Name
Ostrowieckie Centrum Medyczne Anna Olech Cudzik Krzysztof Cudzik s.c.
Department Name
Ostrowieckie Centrum Medyczne
Principal Investigator Name
Anna Olech-Cudzik
Principal Investigator Email
annacudzik@cudmed.pl
Contact Person Name
Anna Olech-Cudzik
Contact Person Email
annacudzik@cudmed.pl

Sweden

Earliest CTIS Part Ii Submission Date
18-06-2025
Latest Decision Or Authorization Date
26-11-2025
Processing Time Days
161
Number Of Sites
3
Number Of Participants
16

Sites

Site Name
Region Skane Skanes Universitetssjukhus
Department Name
Skånes Universitetssjukhus FoUU Lungmedicin, Lung- och allergiforskning
Principal Investigator Name
Jens Richter
Principal Investigator Email
jens.richter@med.lu.se
Contact Person Name
Jens Richter
Contact Person Email
jens.richter@med.lu.se
Site Name
Sahlgrenska University Hospital-Vaestra Goetalandsregionen
Department Name
Sahlgrenska Universitetssjukhuset
Principal Investigator Name
Lowie Vanfleteren
Principal Investigator Email
lowie.vanfleteren@vgregion.se
Contact Person Name
Lowie Vanfleteren
Contact Person Email
lowie.vanfleteren@vgregion.se
Site Name
Karolinska University Hospital
Department Name
Karolinska Universitetssjukhuset - Huddinge
Principal Investigator Name
Valentyna Yasinska
Principal Investigator Email
valentyna.yasinska@ki.se
Contact Person Name
Valentyna Yasinska
Contact Person Email
valentyna.yasinska@ki.se

Sponsor

Primary sponsor

Full Name
Sanofi-Aventis Recherche & Developpement
Organisation Type
Pharmaceutical company
Country Of Registered Address
France

Contract research organisations

Name
Endpoint Clinical Inc.
Responsibilities
code 3
Name
Parexel International Services India Private Limited
Responsibilities
code 8
Name
Eresearchtechnology Inc.
Responsibilities
Imaging reading; code 7

Third parties

  • {"country":"United States","full_name":"Endpoint Clinical Inc.","duties_or_roles":"code 3","organisation_type":"Pharmaceutical company"}
  • {"country":"France","full_name":"Inato","duties_or_roles":"code 2","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Empatica Inc.","duties_or_roles":"Digital biomarker capture","organisation_type":"Pharmaceutical company"}
  • {"country":"Spain","full_name":"Alcura Health Espana S.A.","duties_or_roles":"code 14","organisation_type":"Pharmaceutical company"}
  • {"country":"Italy","full_name":"Depo-pack S.r.l.","duties_or_roles":"AxMP and ancillary material management","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"Imaging reading; code 7","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":"India","full_name":"Parexel International Services India Private Limited","duties_or_roles":"code 8","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Breatheox Limited","duties_or_roles":"Cough night monitoring","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
Dupilumab
Active Substance
DUPILUMAB
Modality
Monoclonal antibody
Routes Of Administration
SUBCUTANEOUS USE
Route
SUBCUTANEOUS USE
Authorisation Status
prodAuthStatus 1
Maximum Dose
Max daily dose 300 mg; max total dose 3600 mg
Investigational Product Name
matched placebo for test product
Modality
Other
Investigational Product Name
Ventolin Evohaler 100 micrograms
Active Substance
SALBUTAMOL
Modality
Small molecule
Routes Of Administration
INHALATIONAL ROUTE
Route
INHALATIONAL ROUTE
Authorisation Status
Marketing authorisation PL 10949/0274 (prodAuthStatus 2)
Maximum Dose
Max daily dose 10 (as listed)
Combination Treatment
Yes

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