Clinical trial • Phase III • Respiratory

TEZEPELUMAB for Chronic obstructive pulmonary disease

Phase III trial of TEZEPELUMAB 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
28-01-2025
First CTIS Authorization Date
12-05-2025

Trial design

Randomised, placebo: tezepelumab-placebo (placebo comparator). active: tezspire 210 mg solution for injection in pre-filled syringe (active investigational product, tezepelumab). route: subcutaneous injection (active product lists subcutaneous injection). dose name indicated as 210 mg for tezspire; specific dosing schedule in-study not specified in the ctis data provided.-controlled Phase III trial in Bulgaria, Denmark, France and others.

Randomised
Yes
Comparator
Placebo: Tezepelumab-placebo (placebo comparator). Active: Tezspire 210 mg solution for injection in pre-filled syringe (active investigational product, TEZEPELUMAB). Route: subcutaneous injection (active product lists SUBCUTANEOUS INJECTION). Dose name indicated as 210 mg for Tezspire; specific dosing schedule in-study not specified in the CTIS data provided.
Target Sample Size
697
Trial Duration For Participant
532

Eligibility

Recruits 697 No vulnerable populations selected (isVulnerablePopulationSelected: false). Participants are adults (aged 40–80). Informed consent is required from adult participants (subject information and informed consent forms [L1 SIS and ICF] are provided); no assent process for minors is described..

Vulnerable Population
No vulnerable populations selected (isVulnerablePopulationSelected: false). Participants are adults (aged 40–80). Informed consent is required from adult participants (subject information and informed consent forms [L1 SIS and ICF] are provided); no assent process for minors is described.

Inclusion criteria

  • {"criterion_text":"- 1. Adult participants 40 to 80 years of age at the time of signing the informed consent.\n- 2. Documented physician-diagnosed COPD for at least 12 months before Visit 1.\n- 3. A post-BD FEV1/FVC < 0.70 and a post-BD FEV1 ≥ 20% and ≤ 70% of the predicted normal value during screening.\n- 4. Documented regular dose of triple inhaled maintanence therapy (ICS+LABA+LAMA), or dual therapy (LABA+LAMA, ICS+LABA,ICS+LAMA) if triple inhaled therapy is considered not appropriate, for at least 3 consecutive months before Visit 1.\n- 5. Documented history ≥2 moderate or ≥1 severe COPD exacerbations within 12 months before Visit1. At least 1 of the 2 moderate exacerbations must have been treated with SCS. At least one of the previous exacerbations should be confirmed to have occurred while the participant was on triple or dual inhaled maintenance therapy.\n- 6. EOS ≥ 150 cells/μL during the screening period.\n- 7. CAT total score ≥ 15 at Visit 1.\n- 8. Current or former smokers (with smoking cessation ≥ 6 months before Visit 1) have a history of at least 10 pack-years of tobacco smoking (1 pack year = 20 cigarettes smoked per day for 1 year)."}

Exclusion criteria

  • {"criterion_text":"- 1. Clinically important lung disease other than COPD (eg, active lung infection, clinically significant bronchiectasis, pulmonary fibrosis, cystic fibrosis, hypoventilation syndrome associated with obesity, lung cancer, alpha 1 anti-trypsin deficiency and primary ciliary dyskinesia), or another diagnosed pulmonary or systemic disease that is associated with elevated peripheral EOS (eg, allergic bronchopulmonary aspergillosis/mycosis, eosinophilic granulomatosis with polyangiitis, hypereosinophilic syndrome).\n- 10. LTOT with signs and/or symptoms of cor pulmonale and/or right ventricular failure, or LTOT > 4.0 litres/minute (L/min) at rest or an oxyhaemoglobin saturation < 89% despite LTOT.\n- 11. Use, or need for chronic use, of any non-invasive positive pressure ventilation device. Stable use of non-invasive ventilation for the treatment of Obstructive Sleep Apnoea is permitted.\n- 12. Maintenance treatment with macrolides or other antibiotics for COPD if the duration of the treatment is < 6 consecutive months before Visit 1.\n- 2. Radiological findings suggestive of a respiratory disease other than COPD that is significantly contributing to the participant’s respiratory symptoms. Radiological findings of pulmonary nodules suspicious for lung cancer, as per applicable guidance, (eg, ACR Lung-RADS v2022, (Christensen et al 2024)) without appropriate follow up before Visit 2.\n- 3. Radiological findings suggestive of acute respiratory infection, if confirmed clinically.\n- 4. Current physician diagnosed asthma according to the Global Initiative for Asthma (GINA 2024 and onwards versions) guidelines or other accepted guidelines, past physician diagnosed asthma including paediatric asthma, or asthma-COPD overlap syndrome.\n- 5. Any unstable disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, immune, psychiatric, or major physical/or cognitive impairment that is not stable in the opinion of the investigator or the sponsor and/or could: − Affect the safety of the participant throughout the study − Influence the findings of the study or their interpretation − Impede the participant’s ability to complete the entire duration of the study and/or comply with the study visit schedule and procedures\n- 6. Unstable cardiovascular disorder (including but not limited to ischemic heart disease, arrhythmia, cardiomyopathy, severe right and/or left heart failure (NYHA class IV)), renal failure, uncontrolled hypertension, as defined by the Investigator, or any other relevant cardiovascular disorder or ECG abnormality that in the Investigator’s judgment may put the participant at risk or negatively affect the outcome of the study.\n- 7. Tuberculosis requiring treatment in the last 12 months before Visit 2. Local guidelines for diagnosis and treatment should be followed.\n- 8. Malignancy, current or past (within 5 years before Visit 1), except for basal cell carcinoma, localised squamous cell carcinoma of the skin, or in situ carcinoma of the cervix provided when a curative therapy was completed at least 12 months before Visit 1.\n- 9. Treatment with systemic immunosuppressive/immunomodulating medications including maintenance use of SCS within the last 12 weeks or 5 half-lives before Visit 1 or during the screening for other reasons than COPD exacerbation. Expected need for chronic use during the study for any reason."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Annualised rate of moderate or severe COPD exacerbations up to 76 weeks","definition_or_measurement_approach":"Annualised rate of moderate or severe COPD exacerbations measured up to 76 weeks (endpoint as stated: \"Annualised rate of moderate or severe COPD exacerbations up to 76 weeks\")."}

Secondary endpoints

  • {"endpoint_text":"- 1. Change from baseline in post-BD FEV1 at Week 52","definition_or_measurement_approach":"Change from baseline in post-bronchodilator FEV1 measured at Week 52."}
  • {"endpoint_text":"- 2. Change from baseline in the SGRQ total score over 52 weeks","definition_or_measurement_approach":"Change from baseline in St George's Respiratory Questionnaire (SGRQ) total score over 52 weeks."}
  • {"endpoint_text":"- 3. Annualised rate of moderate or severe COPD exacerbations up to 76 weeks among participants with screening EOS ≥ 300 cells/μL","definition_or_measurement_approach":"Annualised rate of moderate or severe COPD exacerbations up to 76 weeks in the subgroup with screening blood eosinophils ≥ 300 cells/μL."}
  • {"endpoint_text":"- 4. Annualised rate of severe COPD exacerbations up to 76 weeks","definition_or_measurement_approach":"Annualised rate of severe COPD exacerbations measured up to 76 weeks."}
  • {"endpoint_text":"- 6. Participants achieving a clinically meaningful improvement from baseline in SGRQ total score (4-point score decrease) over 52 weeks","definition_or_measurement_approach":"Proportion of participants achieving ≥4-point decrease in SGRQ total score over 52 weeks."}
  • {"endpoint_text":"- 7. Change from baseline in the CAT total score over 52 weeks","definition_or_measurement_approach":"Change from baseline in COPD Assessment Test (CAT) total score over 52 weeks."}
  • {"endpoint_text":"- 8. Participants achieving a clinically meaningful improvement from baseline in CAT total score (2-point score decrease) over 52 weeks","definition_or_measurement_approach":"Proportion of participants achieving ≥2-point decrease in CAT total score over 52 weeks."}
  • {"endpoint_text":"- 9. Time to first moderate to severe COPD exacerbation up to 76 weeks","definition_or_measurement_approach":"Time-to-event: time from randomisation to first moderate or severe COPD exacerbation up to 76 weeks."}
  • {"endpoint_text":"- 10. Time to first severe COPD exacerbation up to 76 weeks","definition_or_measurement_approach":"Time-to-event: time from randomisation to first severe COPD exacerbation up to 76 weeks."}
  • {"endpoint_text":"- 11. PK: Serum trough concentrations","definition_or_measurement_approach":"Pharmacokinetic endpoint measuring serum trough concentrations of tezepelumab."}
  • {"endpoint_text":"- 12. Immunogenicity: Incidence of anti-drug antibodies and neutralising antibodies","definition_or_measurement_approach":"Incidence of anti-drug antibodies (ADA) and neutralising antibodies assessed during the study."}
  • {"endpoint_text":"- 5. Annualised rate of COPD exacerbations requiring ER visits and/or hospitalisations up to 76 weeks","definition_or_measurement_approach":"Annualised rate of COPD exacerbations leading to emergency room visits and/or hospitalisations up to 76 weeks."}

Recruitment

Digital Remote Recruitment
Yes
Planned Sample Size
697
Recruitment Window Months
46
Consent Approach
Informed consent is required from adult participants. Subject information and informed consent forms (L1_SIS and ICF) are provided, including adult main consent, optional genomics consent, and pregnant partner information. Multiple localized language versions of the SIS/ICF are provided (titles indicate French, Greek, Dutch, Hungarian, Bulgarian, English and others) as shown in the document list.

Methods

  • Study-specific posters (K2_Recruitment material_Poster) — local-language posters referenced in recruitment documents.
  • Leaflets / patient leaflets (K2_Recruitment material_Leaflet) — printed information for patients.
  • Patient Study Guide / recruitment leaflets (K2_Recruitment material_Patient Study Guide) — study information distributed to potential participants.
  • GP letters (K2_Recruitment material_GP Letter) — letters to general practitioners to aid recruitment.
  • Local advertising (K2_Recruitment material Local Ad / Local newspaper) — local ads and newspaper adverts referenced.
  • Social media (K2_Recruitment material Local SoMe post / Local SoMe story / SoMe text) — social media posts and stories used for recruitment.
  • Mail-outs / Utskicksbrev (K2_Recruitment material Utskicksbrev) — local mail distribution.
  • Recruitment vendor / third-party arrangements (K1_Recruitment Arrangement_James Lind Care) — use of recruitment vendor services (James Lind Care) is referenced.

Geography

Total Number Of Sites
73
Total Number Of Participants
293

Bulgaria

Earliest CTIS Part Ii Submission Date
17-04-2025
Latest Decision Or Authorization Date
14-01-2026
Processing Time Days
272
Number Of Sites
13
Number Of Participants
110

Sites

Site Name
Medical Center Pulmovision Ltd.
Contact Person Name
Miroslav Mihaylov
Contact Person Email
miroslavmihailov@abv.bg
Site Name
Multiprofile Hospital For Active Treatment Knyaginya Klementina Sofia EAD
Department Name
Department of pneumology
Contact Person Name
Kalin Aleksandrov
Contact Person Email
k_alexandrov@abv.bg
Site Name
Medical Center Hermes Ruse Ltd.
Contact Person Name
Nikolay Nikolaev
Contact Person Email
nikolay.evgeniev@gmail.com
Site Name
Multi-profile Hospital for Active Treatment Heart and Brain EAD
Department Name
First department of pneumology and phtisiatry
Contact Person Name
Iliya Krachunov
Site Name
Diagnostichno Konsultativen Tsentar 1 Haskovo EOOD
Contact Person Name
Tatyana Slaveykova
Contact Person Email
drtslaveykova@abv.bg
Site Name
Asclepius Medical Center OOD
Contact Person Name
Elena Gyuzeleva
Contact Person Email
dr.gyuzeleva@gmail.com
Site Name
Medical Center St. Ivan Rilski Chudotvorets 2010 EOOD
Contact Person Name
Marin Marinov
Contact Person Email
dr_m_marinov@abv.bg
Site Name
Medical Center Sv. Ivan Rilski EOOD
Contact Person Name
Ivo Iliev
Contact Person Email
ivo_pulmo@mail.bg
Site Name
Medical Center Dianamed 2001 EOOD
Contact Person Name
Angelina Dimitrova
Contact Person Email
dr.andimitrova@abv.bg
Site Name
Diagnostic-Consultative Center Alexandrovska EOOD
Contact Person Name
Radoslav Bilyukov
Contact Person Email
dr-biliykov@mail.bg
Site Name
Medical center Tara Ltd.
Contact Person Name
Marinka Atanasova
Contact Person Email
marinka_bg@abv.bg
Site Name
Medical Center New Rehabilitation Center EOOD
Contact Person Name
Dimo Dimov
Contact Person Email
dmdimov65@yahoo.com
Site Name
Prevencia 2000 MCDMP
Contact Person Name
Vanya Ilieva- Fartunova
Contact Person Email
ilvan@abv.bg

Denmark

Earliest CTIS Part Ii Submission Date
02-05-2025
Latest Decision Or Authorization Date
08-01-2026
Processing Time Days
251
Number Of Sites
5
Number Of Participants
20

Sites

Site Name
Aalborg University Hospital
Department Name
Lungemedicinsk Forskningsenhed
Contact Person Name
Ulla Møller Weinreich
Contact Person Email
ulw@rn.dk
Site Name
Næstved Hospital
Department Name
Lungemedicinsk afd
Contact Person Name
Uffe Bødtger
Contact Person Email
ubt@regionsjaelland.dk
Site Name
Lillebaelt Hospital
Department Name
Lungemed. Amb
Contact Person Name
Ole Hilberg
Contact Person Email
Ole.Hilberg@rsyd.dk
Site Name
Region Hovedstaden
Department Name
Lungemedicinsk Forskningsafdeling
Contact Person Name
Charlotte Ulrik
Contact Person Email
csulrik@dadlnet.dk
Site Name
Odense University Hospital
Department Name
Department of Respiratory Medicine
Contact Person Name
Ingrid Titlestad
Contact Person Email
ingrid.titlestad@rsyd.dk

France

Earliest CTIS Part Ii Submission Date
11-04-2025
Latest Decision Or Authorization Date
08-01-2026
Processing Time Days
272
Number Of Sites
9
Number Of Participants
21

Sites

Site Name
Assistance Publique Hopitaux De Paris
Department Name
Pneumologie
Contact Person Name
Nicolas Roche
Contact Person Email
nicolas.roche@aphp.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Service de Pneumologie et Transplantation Pulmonaire
Contact Person Name
Gaëlle Weisenburger
Contact Person Email
gaelle.weisenburger@aphp.fr
Site Name
Centre Hospitalier Regional Et Universitaire De Brest
Department Name
Département de médecine interne et pneumologie
Contact Person Name
Christophe Gut-Gobert
Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
Service pneumologie - Institut du Thorax
Contact Person Name
Arnaud Cavailles
Contact Person Email
arnaud.cavailles@chu-nantes.fr
Site Name
Centre Hospitalier Universitaire De Montpellier
Department Name
Service des maladies respiratoires - Département pneumologie
Contact Person Name
Arnaud Bourdin
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Centre François Magendie G0 - CIC-P unité pneumologie
Contact Person Name
Pierre-Olivier Girodet
Site Name
Hopital De La Croix-Rousse
Department Name
Service de pneumologie
Contact Person Name
Gilles Devouassoux
Contact Person Email
gilles.devouassoux@chu-lyon.fr
Site Name
Centre Hospitalier Regional De Marseille
Department Name
CIC Bâtiment Etoile - 2e étage
Contact Person Name
Pascal Chanez
Contact Person Email
pascal.chanez@univ-amu.fr
Site Name
Les Hopitaux Universitaires De Strasbourg
Department Name
Service des maladies respiratoires – Centre de Transplantation pulmonaire
Contact Person Name
Benjamin Renaud-Picard

Greece

Earliest CTIS Part Ii Submission Date
14-02-2025
Latest Decision Or Authorization Date
13-05-2025
Processing Time Days
329
Number Of Sites
8
Number Of Participants
37

Sites

Site Name
University General Hospital Of Heraklion
Department Name
Pulmonology Clinic
Contact Person Name
Sofia Schiza
Contact Person Email
schizas@uoc.gr
Site Name
Athens Medical Center S.A.
Department Name
Respiratory Department
Contact Person Name
Dimosthenis Papapetrou
Contact Person Email
dimospapapetroudsa@hotmail.com
Site Name
Thoracic General Hospital Of Athens I Sotiria
Department Name
1st University Pulmonology Clinic
Contact Person Name
Petros Bakakos
Contact Person Email
petros44@hotmail.com
Site Name
General Hospital Of Patras Agios Andreas
Department Name
Pulmonology Department
Contact Person Name
Georgios Effraimidis
Contact Person Email
efrgeorge@gmail.com
Site Name
University General Hospital Of Ioannina
Department Name
Respiratory Clinic
Contact Person Name
Konstantinos Kostikas
Contact Person Email
ktkostikas@gmail.com
Site Name
Athens Naval Hospital
Department Name
Pulmonology Department
Contact Person Name
Nikolaos Zias
Contact Person Email
nikoszias@gmail.com
Site Name
Geniko Nosokomeio Thessalonikis George Papanikolaou
Department Name
Respiratory Department
Contact Person Name
Konstantinos Porpodis
Contact Person Email
kporpodis@yahoo.gr
Site Name
Thermi Clinic S.A.
Department Name
Internal Medicine Department
Contact Person Name
Stavros Tryfon
Contact Person Email
stavrostryfon@yahoo.gr

Hungary

Earliest CTIS Part Ii Submission Date
25-03-2025
Latest Decision Or Authorization Date
13-05-2025
Processing Time Days
259
Number Of Sites
10
Number Of Participants
29

Sites

Site Name
Simplex Kft.
Contact Person Name
Andrea Nagy
Contact Person Email
simplexkft@gmail.com
Site Name
Obudai Egeszseguegyi Centrum Kft.
Contact Person Name
Zsófia Ajtay
Contact Person Email
info@oecresearch.com
Site Name
Edelenyi Koch Robert Korhaz Es Rendelointezet
Contact Person Name
Melinda Szabó
Contact Person Email
pulmo.szbt@gmail.com
Site Name
University Of Debrecen
Department Name
Tüdőgyógyászati Klinika
Contact Person Name
Ildikó Horváth
Contact Person Email
horvath.ildiko@med.unideb.hu
Site Name
Omnimodus Elixir Kft.
Contact Person Name
Erika Unger
Contact Person Email
ungerstudy@gmail.com
Site Name
Reformatus Pulmonologiai Centrum
Contact Person Name
László Kunos
Contact Person Email
orvosigazgato@rpckorhaz.hu
Site Name
Erzsebet Gondozohaz Kft.
Contact Person Name
János Mucsi
Contact Person Email
mucsitrial@gmail.com
Site Name
BKS Research Kft.
Contact Person Name
Ágota Bencze
Contact Person Email
agota.bencze.md@gmail.com
Site Name
Additional site (name as listed in CTIS)
Site Name
Additional site (name as listed in CTIS)

Romania

Earliest CTIS Part Ii Submission Date
01-04-2025
Latest Decision Or Authorization Date
13-01-2026
Processing Time Days
287
Number Of Sites
10
Number Of Participants
33

Sites

Site Name
Clinical Hospital Of Infectious Diseases And Pneumophysiology Dr.Victor Babes Timisoara
Department Name
Pneumologie II
Contact Person Name
Nicoleta Bertici
Contact Person Email
bertnicol2002@yahoo.com
Site Name
Cabinet Medical de Pneumologie Dr Mincu Bogdan
Department Name
Pneumologie
Contact Person Name
Bogdan Mincu
Contact Person Email
mbmincu@gmail.com
Site Name
Spitalul Clinic Judetean De Urgenta Bihor
Department Name
Stationar IV
Contact Person Name
Mircea Marta
Contact Person Email
mircea69m@yahoo.com
Site Name
Fundatia Cardioprevent
Department Name
Pneumologie
Contact Person Name
Stefan Mihaicuta
Contact Person Email
stefan.mihaicuta@umft.ro
Site Name
Institutul De Pneumoftiziologie Marius Nasta
Department Name
Laborator Explorari Functionale Respiratorii Speciale
Contact Person Name
Roxana Nemes
Contact Person Email
roxanamarianemes@gmail.com
Site Name
Clinical Hospital Of Infectious Diseases And Pneumophysiology Dr.Victor Babes Timisoara (second site entry)
Department Name
Pneumologie
Contact Person Name
Stefan Frent
Contact Person Email
stefan_frentz@yahoo.com
Site Name
Elias University Emergency Hospital
Department Name
Pneumologie si Terapie Acuta Respiratorie
Contact Person Name
Dragos Bumbacea
Contact Person Email
d.bumbacea@gmail.com
Site Name
Spitalul Clinic De Pneumoftiziologie Leon Daniello
Department Name
Dispensar TBC
Contact Person Name
Mihaela Carstoniu
Contact Person Email
miha.carmen@yahoo.com
Site Name
Neoclinic Concept S.R.L.
Department Name
Pneumologie
Contact Person Name
Stefan Mihaicuta
Contact Person Email
stefan.mihaicuta@umft.ro
Site Name
Additional site (name as listed in CTIS)

Sweden

Earliest CTIS Part Ii Submission Date
14-02-2025
Latest Decision Or Authorization Date
08-01-2026
Processing Time Days
328
Number Of Sites
6
Number Of Participants
15

Sites

Site Name
Akardo AB
Department Name
AKARDO AB
Contact Person Name
Åke Olsson
Contact Person Email
ake.olsson@akardomedsite.se
Site Name
Region Oerebro Laen
Department Name
Enheten för Kliniska Studier
Contact Person Name
Magnus Olsson
Site Name
Blekinge Tekniska Hoegskola
Department Name
BTH forsknings- och utbildningsklinik
Contact Person Name
Johan Berglund
Site Name
Sahlgrenska University Hospital-Vaestra Goetalandsregionen
Department Name
COPD Center
Contact Person Name
Lowie Vanleteren
Contact Person Email
lowie.vanfleteren@vgregion.se
Site Name
Region Skane Skanes Universitetssjukhus
Department Name
Skånes universitetssjukhus Lund Lung- och allergiforskningen
Contact Person Name
Hamid Akbarshahi
Contact Person Email
hamid.akbarshahi@med.lu.se
Site Name
Karolinska University Hospital
Department Name
Institutet för miljömedicin, C6 Lung-och luftvägsforskning Linden
Contact Person Name
Nikolaos Lazarinis
Contact Person Email
nikolaos.lazarinis@ki.se

Netherlands

Earliest CTIS Part Ii Submission Date
07-05-2025
Latest Decision Or Authorization Date
08-01-2026
Processing Time Days
246
Number Of Sites
5
Number Of Participants
14

Sites

Site Name
Ikazia Ziekenhuis
Department Name
Pulmonology
Contact Person Name
Roxanne Heller-Baan
Contact Person Email
heller@ikazia.nl
Site Name
Academisch Ziekenhuis Maastricht
Department Name
Respiratory Medicine
Contact Person Name
Frits Franssen
Contact Person Email
f.franssen@mumc.nl
Site Name
Sint Franciscus Vlietland Groep Stichting
Department Name
Pulmonology / Respiratory medicine
Contact Person Name
Yasemin Turk
Contact Person Email
yasemin.turk@franciscus.nl
Site Name
Catharina Ziekenhuis Stichting
Department Name
Pulmonology
Contact Person Name
Pascal Wielders
Site Name
Gelre Hospitals
Department Name
Lung diseases and pulmonary research
Contact Person Name
Martijn Goosens
Contact Person Email
goosens.research@gelre.nl

Belgium

Earliest CTIS Part Ii Submission Date
22-04-2025
Latest Decision Or Authorization Date
09-04-2026
Processing Time Days
352
Number Of Sites
7
Number Of Participants
14

Sites

Site Name
Emmaues
Department Name
Pulmonology
Contact Person Name
Muriel Lins
Contact Person Email
Muriel.lins@emmaus.be
Site Name
Universitair Ziekenhuis Gent
Department Name
Respiratory Medicine
Contact Person Name
Guy Brusselle
Contact Person Email
guy.brusselle@ugent.be
Site Name
UZ Leuven
Department Name
Pneumology
Contact Person Name
Wim Janssens
Contact Person Email
wim.janssens@uzleuven.be
Site Name
Ziekenhuis Oost Limburg
Department Name
Pneumology
Contact Person Name
David Ruttens
Contact Person Email
david.ruttens@zol.be
Site Name
Meclinas
Contact Person Name
Julie Casaer
Contact Person Email
julie.casaer@meclinas.com
Site Name
UZ Brussel
Department Name
Pulmonology
Contact Person Name
Eef Vanderhelst
Contact Person Email
eef.vanderhelst@uzbrussel.be
Site Name
Pneumocare
Department Name
Pulmonology
Contact Person Name
Jean-Benoit Martinot
Contact Person Email
martinot.j@respisom.be

Sponsor

Primary sponsor

Full Name
AstraZeneca AB
Organisation Type
Pharmaceutical company
Country Of Registered Address
Sweden

Investigational products

Investigational Product Name
Tezspire 210 mg solution for injection in pre-filled syringe
Active Substance
TEZEPELUMAB
Modality
Monoclonal antibody
Routes Of Administration
SUBCUTANEOUS INJECTION
Route
SUBCUTANEOUS INJECTION
Authorisation Status
Authorised (marketing authorisation EU/1/22/1677/001)
Starting Dose
210 mg
Investigational Product Name
Tezepelumab-placebo
Modality
Other

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