Clinical trial • Phase III • Respiratory

TEZEPELUMAB for Chronic obstructive pulmonary disease (COPD)

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

Trial design

Randomised, placebo (tezepelumab-placebo) - matching placebo; dose/schedule for placebo not specified in available data.-controlled Phase III trial in Czechia, Germany, Spain and others.

Randomised
Yes
Comparator
Placebo (Tezepelumab-placebo) - matching placebo; dose/schedule for placebo not specified in available data.
Target Sample Size
803
Trial Duration For Participant
532

Eligibility

Recruits 803 Vulnerable population selected (isVulnerablePopulationSelected = true). The provided data lists ICF and subject information documents for adult participants (including adult, pregnant partner, pregnant participant, genomics and other addenda) and country-specific ICFs, but explicit details on assent/consent handling for vulnerable individuals are not provided in the supplied data..

Vulnerable Population
Vulnerable population selected (isVulnerablePopulationSelected = true). The provided data lists ICF and subject information documents for adult participants (including adult, pregnant partner, pregnant participant, genomics and other addenda) and country-specific ICFs, but explicit details on assent/consent handling for vulnerable individuals are not provided in the supplied data.

Inclusion criteria

  • {"criterion_text":"- 1. Adult participants 40 to 80 years of age at the time of signing the informed consent."}
  • {"criterion_text":"- 2. Documented physician-diagnosed COPD for at least 12 months before Visit 1."}
  • {"criterion_text":"- 3. A post-BD FEV1/FVC < 0.70 and a post-BD FEV1 ≥ 20% and ≤70% of the predicted normal value during screening."}
  • {"criterion_text":"- 4. Documented regular dose of triple inhaled maintenance therapy (ICS+LABA+LAMA), or dualtherapy (LABA+LAMA, ICS+LABA, ICS+LAMA) if triple therapy is considered not appropriate, for atleast 3 consecutive months before Visit 1."}
  • {"criterion_text":"- 5. Documented history ≥2 moderate or ≥1 severe COPD exacerbations within 12 months before Visit 1. 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."}
  • {"criterion_text":"- 6. EOS ≥ 150 cells/μL during the screening period."}
  • {"criterion_text":"- 7. CAT total score ≥ 15 at Visit 1."}
  • {"criterion_text":"- 8. Current or former smokers (with smoking cessation ≥ 6 monthsbefore 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, eosinophilicgranulomatosis with polyangiitis, hypereosinophilic syndrome)."}
  • {"criterion_text":"- 10. LTOT with signs and/or symptoms of cor pulmonale and/or rightventricular failure, or LTOT > 4.0 litres/minute (L/min) at rest oran oxyhaemoglobin saturation < 89% despite LTOT."}
  • {"criterion_text":"- 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."}
  • {"criterion_text":"- 12. Maintenance treatment with macrolides or other antibiotics forCOPD if the duration of the treatment is < 6 consecutive months before Visit 1."}
  • {"criterion_text":"- 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 nodulessuspicious for lung cancer, as per applicable guidance, (eg, ACRLung-RADS v2022, (Christensen et al 2024)) without appropriatefollow up before Visit 2."}
  • {"criterion_text":"- 3. Radiological findings suggestive of acute respiratory infection, if confirmed clinically."}
  • {"criterion_text":"- 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."}
  • {"criterion_text":"- 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/orcould: − 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 durationof the study and/or comply with the study visit schedule and procedures"}
  • {"criterion_text":"- 6. Unstable cardiovascular disorder (including but not limited toischemic heart disease, arrhythmia, cardiomyopathy, severe right and/or left heart failure (NYHA class IV)), renal failure,uncontrolled hypertension, as defined by the Investigator, or anyother 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."}
  • {"criterion_text":"- 7. Tuberculosis requiring treatment in the last 12 months before Visit 2. Local guidelines for diagnosis and treatment should be followed."}
  • {"criterion_text":"- 8. Malignancy, current or past (within 5 years before Visit 1), except for basal cell carcinoma, localised squamous cell carcinoma of thes kin, or in situ carcinoma of the cervix provided when a curative therapy was completed at least 12 months before Visit 1."}
  • {"criterion_text":"- 9. Treatment with systemic immunosuppressive/immunomodulatingmedications 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 chronicuse 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 calculated up to 76 weeks (no further measurement detail provided in the available data)."}

Secondary endpoints

  • {"endpoint_text":"- 1. Change from baseline in pre-BD FEV1 at Week 52","definition_or_measurement_approach":"Change from baseline in pre-bronchodilator FEV1 measured at Week 52 versus baseline."}
  • {"endpoint_text":"- 3. 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":"- 4. 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 exacerbation rate up to 76 weeks in the subgroup with screening blood eosinophils ≥300 cells/μL."}
  • {"endpoint_text":"- 5. Annualised rate of severe COPD exacerbations requiring ER visits and/or hospitalisations up to 76 weeks.","definition_or_measurement_approach":"Annualised rate of severe exacerbations (those requiring ER visit and/or hospitalisation) 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 with a ≥4-point decrease in SGRQ total score over 52 weeks compared with baseline."}
  • {"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 frombaseline in CAT total score (2-point score decrease) over 52 weeks.","definition_or_measurement_approach":"Proportion of participants with a ≥2-point decrease in CAT total score over 52 weeks versus baseline."}
  • {"endpoint_text":"- 9. Time to first moderate to severe COPD exacerbation up to 76 weeks","definition_or_measurement_approach":"Time (days) 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 (days) from randomisation to first severe COPD exacerbation, up to 76 weeks."}
  • {"endpoint_text":"- 11. PK: Serum trough concentrations","definition_or_measurement_approach":"Pharmacokinetics endpoint measuring serum trough concentrations of tezepelumab."}
  • {"endpoint_text":"- 12. Immunogenicity: Incidence of anti-drug antibodies and neutralising antibodies","definition_or_measurement_approach":"Incidence and characterization of anti-drug antibodies and neutralising antibodies to tezepelumab."}
  • {"endpoint_text":"- 2. 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."}

Recruitment

Digital Remote Recruitment
Yes
Planned Sample Size
803
Recruitment Window Months
31
Consent Approach
Informed consent is obtained from adult participants (study enrolment restricted to adults aged 40–80). Subject information and ICF documents are provided (documents listed for adult participants, pregnant participant/partner, genomics addenda and country-specific ICFs). Protocol and synopsis translations and ICF documents are available for multiple languages/countries (English and country-specific documents/translations such as Spanish, Polish, Slovak, Italian indicated in the materials). Specific details on assent (not applicable as only adults enrolled) or additional vulnerable-consent procedures are not provided in the available data.

Methods

  • Posters: country-specific recruitment posters listed in recruitment materials (documents titled 'K2_Recruitment material Poster' and similar).
  • Leaflets/Text leaflets: text leaflets and online text materials referenced (e.g., 'K2_Recruitment material_Text Leaflet', 'K2_Recruitment material_Text Online_PRATIA SA').
  • Website/Online information: Website information and online recruitment text (e.g., 'K2_Recruitment material_Website Information_PRATIA SA').
  • General advertisement materials: general advertisement packages (document 'K2_Recruitment material general advertisment').
  • Country-specific recruitment arrangements: K1 recruitment arrangements documents exist for multiple countries (Germany, Spain, Italy, Poland, Slovakia, Denmark, Czechia) indicating tailored, country-specific recruitment materials.

Geography

Total Number Of Sites
56
Total Number Of Participants
187

Czechia

Earliest CTIS Part Ii Submission Date
29-04-2025
Latest Decision Or Authorization Date
02-12-2025
Processing Time Days
217
Number Of Sites
11
Number Of Participants
20

Sites

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
Site Name
Plicni centrum s.r.o.
Principal Investigator Name
Pavel Spas
Principal Investigator Email
spaspavel@seznam.cz
Contact Person Name
Pavel Spas
Contact Person Email
spaspavel@seznam.cz
Site Name
Fakultni Nemocnice Brno
Department Name
Klinika nemoci plicnich a tuberkulozy
Principal Investigator Name
Milan Sova
Principal Investigator Email
sova.milan@fnbrno.cz
Contact Person Name
Milan Sova
Contact Person Email
sova.milan@fnbrno.cz
Site Name
Cefispiro s.r.o.
Principal Investigator Name
Petra Filipova
Principal Investigator Email
pphilip@seznam.cz
Contact Person Name
Petra Filipova
Contact Person Email
pphilip@seznam.cz
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
Fakultni Nemocnice Plzen
Department Name
Klinika pneumologie a ftizeologie
Principal Investigator Name
Ondrej Fibigr
Principal Investigator Email
fibigro@fnplzen.cz
Contact Person Name
Ondrej Fibigr
Contact Person Email
fibigro@fnplzen.cz
Site Name
Plicni alergo s.r.o.
Principal Investigator Name
Radka Mokosova
Principal Investigator Email
radka.mokosova@seznam.cz
Contact Person Name
Radka Mokosova
Contact Person Email
radka.mokosova@seznam.cz
Site Name
Plicni Stredisko Teplice s.r.o.
Principal Investigator Name
Stanislav Holub
Principal Investigator Email
stanislavholub@seznam.cz
Contact Person Name
Stanislav Holub
Contact Person Email
stanislavholub@seznam.cz
Site Name
MUDr. I. Cierna Peterova s.r.o.
Principal Investigator Name
Ivana Cierna Peterova
Principal Investigator Email
trnbrnl@gmail.com
Contact Person Name
Ivana Cierna Peterova
Contact Person Email
trnbrnl@gmail.com
Site Name
Ordinace chorob plicnich s.r.o.
Principal Investigator Name
Zuzana Kovarikova
Principal Investigator Email
kovarikova@plicnipraha.cz
Contact Person Name
Zuzana Kovarikova
Contact Person Email
kovarikova@plicnipraha.cz
Site Name
MUDr. I. Cierna Peterova s.r.o.
Principal Investigator Name
Ivana Cierna Peterova
Principal Investigator Email
trnbrnl@gmail.com
Contact Person Name
Ivana Cierna Peterova
Contact Person Email
trnbrnl@gmail.com

Germany

Earliest CTIS Part Ii Submission Date
08-04-2025
Latest Decision Or Authorization Date
03-12-2025
Processing Time Days
239
Number Of Sites
7
Number Of Participants
22

Sites

Site Name
Lungenfacharztzentrum an den Quellen
Principal Investigator Name
Peter Fried
Principal Investigator Email
peter-fried@web.de
Contact Person Name
Peter Fried
Contact Person Email
peter-fried@web.de
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
Velocity Clinical Research Germany GmbH
Principal Investigator Name
Isabelle Schenkenberger
Principal Investigator Email
ischenkenberger@velocityclinical.com
Contact Person Name
Isabelle Schenkenberger
Site Name
Romed Klinikum Rosenheim
Department Name
Lungenfacharztpraxis / Pneumologische Ambulanz
Principal Investigator Name
Stephan Budweiser
Principal Investigator Email
Stephan.budweiser@ro-med.de
Contact Person Name
Stephan Budweiser
Contact Person Email
Stephan.budweiser@ro-med.de
Site Name
Pneumologicum im Suedstadtforum Dr. Alexander Schulz Dr. Martin Hoffmann Dr. Henning Geldmacher PD Dr. Hendrik Suhling Fachaerzte fuer Innere Medizin Pneumologie Partnerschaftsgesellschaft
Principal Investigator Name
Martin Hoffmann
Principal Investigator Email
hoffmann@pneumologicum.de
Contact Person Name
Martin Hoffmann
Contact Person Email
hoffmann@pneumologicum.de
Site Name
Lungenfachklinik Immenhausen
Principal Investigator Name
Peter Hammerl
Principal Investigator Email
hammerl@lungenfachklinik-immenhausen.de
Contact Person Name
Peter Hammerl
Site Name
Zentrum Fuer Ambulante Pneumologische Forschung Marburg GbR
Principal Investigator Name
Lukas Jerrentrup
Principal Investigator Email
jerrentrup@studienzentrum-marburg.de
Contact Person Name
Lukas Jerrentrup

Spain

Earliest CTIS Part Ii Submission Date
09-04-2025
Latest Decision Or Authorization Date
02-12-2025
Processing Time Days
237
Number Of Sites
10
Number Of Participants
38

Sites

Site Name
Hospital Clinico Universitario De Valencia
Department Name
Servicio Neumologia
Principal Investigator Name
Jaime Signes-Costa
Principal Investigator Email
jaimesignescosta@gmail.com
Contact Person Name
Jaime Signes-Costa
Contact Person Email
jaimesignescosta@gmail.com
Site Name
University Hospital Son Espases
Department Name
Servicio Neumologia
Principal Investigator Name
Francisco Borja Garcia-Cosio Piqueras
Principal Investigator Email
borja.cosio@ssib.es
Contact Person Name
Francisco Borja Garcia-Cosio Piqueras
Contact Person Email
borja.cosio@ssib.es
Site Name
Hospital Universitario Virgen De La Victoria
Department Name
Servicio Neumologia
Principal Investigator Name
Jose Luis Velasco Garrido
Principal Investigator Email
jlvelascogarrido@hotmail.com
Contact Person Name
Jose Luis Velasco Garrido
Contact Person Email
jlvelascogarrido@hotmail.com
Site Name
Hospital General Universitario Gregorio Maranon
Department Name
Servicio Neumologia
Principal Investigator Name
Luis Puente Maestu
Principal Investigator Email
luis.puente@salud.madrid.org
Contact Person Name
Luis Puente Maestu
Contact Person Email
luis.puente@salud.madrid.org
Site Name
Hospital Universitario De Cruces
Department Name
Servicio Neumologia
Principal Investigator Name
Patricia Sobradillo Ecenarro
Principal Investigator Email
psobradillo@separ.es
Contact Person Name
Patricia Sobradillo Ecenarro
Contact Person Email
psobradillo@separ.es
Site Name
Hospital Universitario Virgen De Las Nieves
Department Name
Servicio Neumologia
Principal Investigator Name
Bernardino Alcazar Navarrete
Principal Investigator Email
balcazarnavarrete@gmail.com
Contact Person Name
Bernardino Alcazar Navarrete
Contact Person Email
balcazarnavarrete@gmail.com
Site Name
Hospital Clinic De Barcelona
Department Name
Servicio Neumologia
Principal Investigator Name
Nestor Soler Porcar
Principal Investigator Email
nsoler@clinic.cat
Contact Person Name
Nestor Soler Porcar
Contact Person Email
nsoler@clinic.cat
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Servicio Neumologia
Principal Investigator Name
Francisco Ortega-Ruiz
Principal Investigator Email
francisco.ortega.sspa@juntadeandalucia.es
Contact Person Name
Francisco Ortega-Ruiz
Site Name
Hospital Universitario De Navarra
Department Name
Servicio Neumologia
Principal Investigator Name
Pablo Antonio Sanchez Salcedo
Principal Investigator Email
pa.sanchez.salcedo@navarra.es
Contact Person Name
Pablo Antonio Sanchez Salcedo
Contact Person Email
pa.sanchez.salcedo@navarra.es
Site Name
Hospital Universitario De Granada / Hospital Universitario Virgen De Las Nieves (entry duplication possible)
Department Name
Servicio Neumologia
Principal Investigator Name
Bernardino Alcazar Navarrete
Principal Investigator Email
balcazarnavarrete@gmail.com
Contact Person Name
Bernardino Alcazar Navarrete
Contact Person Email
balcazarnavarrete@gmail.com

Slovakia

Earliest CTIS Part Ii Submission Date
14-04-2025
Latest Decision Or Authorization Date
01-12-2025
Processing Time Days
231
Number Of Sites
4
Number Of Participants
8

Sites

Site Name
Meditrez s.r.o.
Department Name
Pneumology Outpacient Care
Principal Investigator Name
Antónia Marinčáková
Principal Investigator Email
antoniamarincakova@gmail.com
Contact Person Name
Antónia Marinčáková
Contact Person Email
antoniamarincakova@gmail.com
Site Name
Fakultna Nemocnica Trnava
Department Name
Pneumology and Phtiseology Department
Principal Investigator Name
Miroslava Čulagová
Principal Investigator Email
miroslava.culagova@fntt.sk
Contact Person Name
Miroslava Čulagová
Contact Person Email
miroslava.culagova@fntt.sk
Site Name
Zapa Jj s.r.o.
Department Name
Pneumology Outpacient Care
Principal Investigator Name
Ján Plutinský
Principal Investigator Email
plutinskyjan@gmail.com
Contact Person Name
Ján Plutinský
Contact Person Email
plutinskyjan@gmail.com
Site Name
Inspiro s.r.o.
Department Name
Pneumology Outpacient Care
Principal Investigator Name
Alexander Golubov
Principal Investigator Email
agolubov0904@gmail.com
Contact Person Name
Alexander Golubov
Contact Person Email
agolubov0904@gmail.com

Denmark

Earliest CTIS Part Ii Submission Date
02-05-2025
Latest Decision Or Authorization Date
03-02-2026
Processing Time Days
277
Number Of Sites
1
Number Of Participants
2

Sites

Site Name
Region Hovedstaden
Department Name
Lungmedicinsk Forskningsenhed
Principal Investigator Name
Asger Sverrild
Principal Investigator Email
asger.sverrild@regionh.dk
Contact Person Name
Asger Sverrild
Contact Person Email
asger.sverrild@regionh.dk

Italy

Earliest CTIS Part Ii Submission Date
27-03-2025
Latest Decision Or Authorization Date
20-04-2026
Processing Time Days
389
Number Of Sites
9
Number Of Participants
35

Sites

Site Name
University Hospital Of Ferrara
Department Name
Respiratory Unit
Principal Investigator Name
Alberto Papi
Principal Investigator Email
ppa@unife.it
Contact Person Name
Alberto Papi
Contact Person Email
ppa@unife.it
Site Name
Azienda Ospedaliero Universitaria Careggi
Department Name
Respiratory and Critical Care Unit
Principal Investigator Name
Federico Lavorini
Principal Investigator Email
Federico.lavorini@unifi.it
Contact Person Name
Federico Lavorini
Contact Person Email
Federico.lavorini@unifi.it
Site Name
Azienda Unita' Locale Socio Sanitaria N. 2 Marca Trevigiana
Department Name
Pneumology Unit
Principal Investigator Name
Francesco Menzella
Principal Investigator Email
francesco.menzella@aulss2.veneto.it
Contact Person Name
Francesco Menzella
Site Name
Fondazione IRCCS Policlinico San Matteo
Department Name
S.C. Pneumologia
Principal Investigator Name
Angelo Guido Corsico
Principal Investigator Email
corsico@unipv.it
Contact Person Name
Angelo Guido Corsico
Contact Person Email
corsico@unipv.it
Site Name
Fondazione Policlinico Universitario Campus Bio-medico
Department Name
Unit of Internal Medicine
Principal Investigator Name
Panaiotis Finamore
Principal Investigator Email
p.finamore@policlinicocampus.it
Contact Person Name
Panaiotis Finamore
Site Name
Istituti Clinici Scientifici Maugeri S.p.A.
Department Name
Respiratory Pathophysiology Service
Principal Investigator Name
Dina Visca
Principal Investigator Email
dina.visca@icsmaugeri.it
Contact Person Name
Dina Visca
Contact Person Email
dina.visca@icsmaugeri.it
Site Name
Azienda Ospedaliero Universitaria Di Sassari
Department Name
Pneumologia Clinica e Interventistica
Principal Investigator Name
Pietro Pirina
Principal Investigator Email
pietro.pirina@aouss.it
Contact Person Name
Pietro Pirina
Contact Person Email
pietro.pirina@aouss.it
Site Name
Azienda Ospedaliera Dei Colli
Department Name
U.O.C. Clinica Pneumologica
Principal Investigator Name
Andrea Bianco
Principal Investigator Email
Andrea.bianco@unicampania.it
Contact Person Name
Andrea Bianco
Contact Person Email
Andrea.bianco@unicampania.it
Site Name
Istituti Clinici Scientifici Maugeri S.p.A. (Telese Terme location)
Department Name
Pulmonary Rehabilitation Department
Principal Investigator Name
Mauro Maniscalco
Principal Investigator Email
Mauro.maniscalco@icsmaugeri.it
Contact Person Name
Mauro Maniscalco
Contact Person Email
Mauro.maniscalco@icsmaugeri.it

Poland

Earliest CTIS Part Ii Submission Date
22-04-2025
Latest Decision Or Authorization Date
29-04-2026
Processing Time Days
372
Number Of Sites
14
Number Of Participants
62

Sites

Site Name
Promed P.Lach R.Glowacki Sp. j.
Department Name
Centrum Medyczne Promed
Principal Investigator Name
Bozena Zurowicz
Principal Investigator Email
bzurowicz@cmpromed.pl
Contact Person Name
Bozena Zurowicz
Contact Person Email
bzurowicz@cmpromed.pl
Site Name
Cbk Med Clinic Sp. z o.o.
Department Name
CBK Centrum Badan
Principal Investigator Name
Maria Wozniak
Principal Investigator Email
maria.wozniak@cbkmedclinic.pl
Contact Person Name
Maria Wozniak
Contact Person Email
maria.wozniak@cbkmedclinic.pl
Site Name
Centrum Medycyny Oddechowej Mroz Sp. j.
Department Name
Centrum Medycyny Oddechowej Mroz-Ambulatorium
Principal Investigator Name
Robert Mroz
Principal Investigator Email
robmmroz@gmail.com
Contact Person Name
Robert Mroz
Contact Person Email
robmmroz@gmail.com
Site Name
Centrum Medyczne Kermed Renata Bijata-Bronisz I Ewa Kowalinska Sp. j.
Department Name
NZOZ Centrum Medyczne KERmed
Principal Investigator Name
Renata Bijata-Bronisz
Principal Investigator Email
renata.bijata-bronisz@kermed.pl
Contact Person Name
Renata Bijata-Bronisz
Site Name
Mcbk s.c. Iwona Czajkowska Anna Podrazka Szczepaniak
Department Name
MCBK
Principal Investigator Name
Anna Podrazka-Szczepaniak
Principal Investigator Email
annaps@mcbk.pl
Contact Person Name
Anna Podrazka-Szczepaniak
Contact Person Email
annaps@mcbk.pl
Site Name
B&R Clinical Sp. z o.o.
Department Name
Centrum Medyczne B & R Clinical
Principal Investigator Name
Oskar Solarski
Principal Investigator Email
oskar.solarski@brclinical.pl
Contact Person Name
Oskar Solarski
Contact Person Email
oskar.solarski@brclinical.pl
Site Name
Pro Familia Altera Sp. z o.o.
Department Name
Pro Familia Altera Poradnia Wielospecjalistyczna
Principal Investigator Name
Danuta Wronska
Principal Investigator Email
dwronska@profamilia.katowice.pl
Contact Person Name
Danuta Wronska
Site Name
Alergologia Plus Sp. z o.o.
Department Name
Ośrodek Alergologia Plus
Principal Investigator Name
Michał Springer
Principal Investigator Email
michal.springer.pl@gmail.com
Contact Person Name
Michał Springer
Contact Person Email
michal.springer.pl@gmail.com
Site Name
Pratia S.A.
Department Name
Centrum Medyczne Pratia Bydgoszcz
Principal Investigator Name
Jacek Duleba
Principal Investigator Email
jduleba@pratia.pl
Contact Person Name
Jacek Duleba
Contact Person Email
jduleba@pratia.pl
Site Name
Centrum Innowacyjnych Terapii Sp. z o.o.
Department Name
Centrum Innowacyjnych Terapii Sp.z o.o Oddzial Piaseczno
Principal Investigator Name
Luiza Jonczak
Principal Investigator Email
luiza.jonczak@citrials.pl
Contact Person Name
Luiza Jonczak
Contact Person Email
luiza.jonczak@citrials.pl
Site Name
Szpital Powiatowy W Chrzanowie
Department Name
Oddzial Chorob Pluc
Principal Investigator Name
Rafal Harat
Principal Investigator Email
haratb@interia.pl
Contact Person Name
Rafal Harat
Contact Person Email
haratb@interia.pl
Site Name
Zbigniew Zegota Specjalistyczny Osrodek Leczniczo Badawczy
Principal Investigator Name
Joanna Piskorz-Wapinska
Principal Investigator Email
jpiskorzwapinska@gmail.com
Contact Person Name
Joanna Piskorz-Wapinska
Contact Person Email
jpiskorzwapinska@gmail.com
Site Name
Endo-Med Sp. z o.o.
Department Name
ENDO-MED Centrum Medyczne
Principal Investigator Name
Stefan Gruszka
Principal Investigator Email
sg.badania@endo-med.pl
Contact Person Name
Stefan Gruszka
Contact Person Email
sg.badania@endo-med.pl
Site Name
Clinical Best Solutions Sp. z o.o. S.K.
Department Name
Gabinet Lekarski
Principal Investigator Name
Barbara Rybacka-Chabros
Principal Investigator Email
b.rybacka.chabros@gmail.com
Contact Person Name
Barbara Rybacka-Chabros
Contact Person Email
b.rybacka.chabros@gmail.com

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
Marketing authorisation EU/1/22/1677/001
Starting Dose
210 mg
Dose Levels
210 mg
Investigational Product Name
Tezepelumab-placebo
Modality
Other

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