Clinical trial • Phase III • Immunology|Gastroenterology|Rare Disease
TEZEPELUMAB for Eosinophilic esophagitis
Phase III trial of TEZEPELUMAB for Eosinophilic esophagitis.
Overview
- Trial Therapeutic Area
- Immunology|Gastroenterology|Rare Disease
- Trial Disease
- Eosinophilic esophagitis
- Trial Stage
- Phase III
- Drug Modality
- Monoclonal antibody
- Paediatric Trial
- Yes
Key dates
- Initial CTIS Submission Date
- 15-05-2024
- First CTIS Authorization Date
- 24-06-2024
Trial design
Randomised, placebo every 4 weeks (placebo q4w) as comparator arm; active arms: 210 mg tezepelumab every 4 weeks and 420 mg tezepelumab every 4 weeks-controlled Phase III trial across 53 sites in Finland, Denmark, Austria and others.
- Randomised
- Yes
- Comparator
- placebo every 4 weeks (placebo Q4W) as comparator arm; active arms: 210 mg tezepelumab every 4 weeks and 420 mg tezepelumab every 4 weeks
- Target Sample Size
- 149
- Trial Duration For Participant
- 448
Eligibility
Recruits 149 paediatric patients.
- Vulnerable Population
- Adolescents are included (participants aged 12 to 17). Inclusion criterion 1 references signing the "informed consent/assent." Subject information and informed consent forms and paediatric assent documents are included in the submitted documentation (paediatric ICFs and paediatric assent forms are present in the documents list), indicating assent for minors and consent by parent/legal guardian as applicable.
Inclusion criteria
- {"criterion_text":"- 1. Participant must be 12 to 80 years of age inclusive, at the time of signing the informed consent/assent.\n- 2. Weight ≥ 40 kg at Visit 1\n- 3. Established diagnosis of EoE with a previous EGD and esophageal biopsy confirming a diagnosis of EoE.\n- 4. Participants who have symptomatic EoE as defined by a history of on average at least 2 episodes of dysphagia (any severity of food going down slowly or being stuck in the throat) per week in the 4 weeks prior to Visit 1.\n- 5. Must remain on a stabilized diet for at least 8 weeks prior to Visit 1 and during the course of the study (stable diet is defined as no initiation of single or multiple elimination diets or reintroduction of previously eliminated food groups).\n- 6. May be on any background medication for EoE, for example PPI and/or STC, during the course of the study, as long as background medications have been stable for at least 8 weeks prior to the screening/run-in period (Visit 1) and there is agreement not to change background medication or dosage unless medically indicated, during the screening/run-in and treatment period.\n- 7. Participants currently leukotriene inhibitors and/or steroid treatments for asthma or allergies that are inhaled or administered intranasally, must report a stable dose for at least 4 weeks prior to the screening/run-in period (Visit 1).\n- 8. If a medication for EoE (including PPI and/or STC) is discontinued prior to the screening/run-in, there should be a washout period of at least 8 weeks prior to Visit 1. Discontinuation of any marketed biologic (monoclonal or polyclonal antibody) should have a washout period of 4 months or 5 half-lives prior to Visit 1, whichever is longer.\n- 9. Participants should have previously documented standard of care treatment, which could include PPI and/or STC and/or diet"}
Exclusion criteria
- {"criterion_text":"- 1. Other gastrointestinal disorders such as active Helicobacter pylori infection, history of achalasia, esophageal varices, Crohn's disease, ulcerative colitis, inflammatory bowel disease, celiac disease, eosinophilic enteritis, colitis, diverticulitis, irritable bowel syndrome, or other clinically significant gastrointestinal conditions as per Investigator discretion.\n- 2. Esophageal stricture that prevents the easy passage of a standard endoscope or any critical esophageal stricture that requires dilation at screening.\n- 3. Use of a feeding tube, or having a pattern of not eating solid food ≥ 3 days of the week. Solid food is defined as food that requires chewing before swallowing\n- 4. Hypereosinophilic syndrome.\n- 5. EGPA vasculitis.\n- 6. Esophageal dilation performed within 8 weeks prior to screening."}
Endpoints
Primary endpoints
- {"endpoint_text":"- 1. Histologic response of peak esophageal eosinophil per HPF count of ≤ 6 across all available esophageal levels at Week 24","definition_or_measurement_approach":"Histologic response defined as peak esophageal eosinophil count per high-power field (HPF) ≤ 6 across all available esophageal levels measured at Week 24."}
- {"endpoint_text":"- 2. Change from baseline in DSQ score at Week 24","definition_or_measurement_approach":"Change from baseline in DSQ (Dysphagia Symptom Questionnaire) score assessed at Week 24."}
Secondary endpoints
- {"endpoint_text":"- 1. Change from baseline in EoE EREFS at Week 24 and Week 52","definition_or_measurement_approach":"Change from baseline in EREFS (endoscopic reference score for EoE) measured at Weeks 24 and 52 (centrally-read)."}
- {"endpoint_text":"- 2. Change from baseline in EoE-HSS grade score at Week 24 and Week 52","definition_or_measurement_approach":"Change from baseline in EoE-HSS (histologic scoring system) grade score measured at Weeks 24 and 52 (centrally-read)."}
- {"endpoint_text":"- 3. Change from baseline in EoE-HSS stage score at Week 24 and Week 52","definition_or_measurement_approach":"Change from baseline in EoE-HSS stage score measured at Weeks 24 and 52 (centrally-read)."}
- {"endpoint_text":"- 4. Histologic response of peak esophageal eosinophil per HPF count of ≤ 6 across all available esophageal levels at Week 52","definition_or_measurement_approach":"Histologic response defined as peak esophageal eosinophil count per HPF ≤ 6 across esophageal levels measured at Week 52."}
- {"endpoint_text":"- 5. Change from baseline in DSQ score at Week 52","definition_or_measurement_approach":"Change from baseline in DSQ score assessed at Week 52."}
- {"endpoint_text":"- 6. Endoscopic response of total EREFS score of 0 to ≤ 2 with no score > 1 for any of the components and no worsening in any individual component from baseline across all esophageal levels (ie, proximal, mid, and distal) at Week 52","definition_or_measurement_approach":"Endoscopic response defined by total EREFS score 0 to ≤ 2, no component >1, and no worsening from baseline across proximal, mid, and distal esophageal levels at Week 52."}
- {"endpoint_text":"- 7. Endoscopic inflammatory remission of EREFS inflammatory subscore (including edema, exudate, and furrows components) of 0 with no worsening in rings or stricture from baseline across all esophageal levels at Week 52.","definition_or_measurement_approach":"Endoscopic inflammatory remission defined as inflammatory subscore (edema, exudate, furrows) = 0 with no worsening in rings or stricture from baseline at Week 52."}
- {"endpoint_text":"- 8. Total endoscopic remission of total EREFS score of 0 across all esophageal levels at Week 52.","definition_or_measurement_approach":"Total endoscopic remission defined as total EREFS score = 0 across all esophageal levels at Week 52."}
- {"endpoint_text":"- 9. Change from baseline in peak esophageal eosinophil count (EOS/HPF) at Week 24 and Week 52","definition_or_measurement_approach":"Change from baseline in peak esophageal eosinophil count (EOS/HPF) measured at Weeks 24 and 52."}
- {"endpoint_text":"- 10. Changes from baseline in PEESS Module at Week 24 and Week 52 (adolescents only)","definition_or_measurement_approach":"Change from baseline in PEESS (pediatric EoE symptom module) for adolescent participants measured at Weeks 24 and 52."}
- {"endpoint_text":"- 11. Serum trough concentrations at Weeks 0, 4, 12, and 52","definition_or_measurement_approach":"Measurement of serum trough (pre-dose) concentrations of tezepelumab at Weeks 0, 4, 12, and 52."}
- {"endpoint_text":"- 12. Anti-drug antibody at Weeks 0, 12, 24, and 52","definition_or_measurement_approach":"Assessment of anti-drug (immunogenicity) antibodies at Weeks 0, 12, 24, and 52."}
Recruitment
- Planned Sample Size
- 149
- Recruitment Window Months
- 36
- Consent Approach
- Adults provide informed consent. Adolescents (aged 12-17) are included and the protocol references signing "informed consent/assent"; paediatric subject information, paediatric ICFs and paediatric assent documents are present in the submitted documentation. ICFs and assent forms are provided as country- and language-specific documents (examples in the submission include English, Dutch, French, Greek, Spanish, Italian, German, Swedish, Czech/Slovak versions among others). Parental/guardian consent plus youth assent processes are used for minors as indicated by the paediatric ICF/assent documentation.
Geography
- Total Number Of Sites
- 53
- Total Number Of Participants
- 211
Finland
- Latest Decision Or Authorization Date
- 19-01-2026
- Number Of Sites
- 3
- Number Of Participants
- 22
Sites
- Site Name
- Kuopio University Hospital
- Principal Investigator Name
- Lauri von Wright
- Principal Investigator Email
- lauri.vonwright@kuh.fi
- Contact Person Name
- Lauri von Wright
- Contact Person Email
- lauri.vonwright@kuh.fi
- Site Name
- HUS-Yhtymae
- Principal Investigator Name
- Lauri Puustinen
- Principal Investigator Email
- lauri.puustinen@hus.fi
- Contact Person Name
- Lauri Puustinen
- Contact Person Email
- lauri.puustinen@hus.fi
- Site Name
- Turku University Hospital
- Principal Investigator Name
- Kimmo Salminen
- Principal Investigator Email
- kimmo.salminen@tyks.fi
- Contact Person Name
- Kimmo Salminen
- Contact Person Email
- kimmo.salminen@tyks.fi
Denmark
- Latest Decision Or Authorization Date
- 14-01-2026
- Number Of Sites
- 3
- Number Of Participants
- 13
Sites
- Site Name
- Aalborg University Hospital
- Principal Investigator Name
- Asbjørn Mohr Drewes
- Principal Investigator Email
- amd@rn.dk
- Contact Person Name
- Asbjørn Mohr Drewes
- Contact Person Email
- amd@rn.dk
- Site Name
- Region Sjaelland
- Principal Investigator Name
- Synne Semb
- Principal Investigator Email
- sys@regionsjaelland.dk
- Contact Person Name
- Synne Semb
- Contact Person Email
- sys@regionsjaelland.dk
- Site Name
- Odense University Hospital
- Principal Investigator Name
- Troels Havelund
- Principal Investigator Email
- Troels.Havelund@rsyd.dk
- Contact Person Name
- Troels Havelund
- Contact Person Email
- Troels.Havelund@rsyd.dk
Austria
- Latest Decision Or Authorization Date
- 07-04-2025
- Number Of Sites
- 3
- Number Of Participants
- 4
Sites
- Site Name
- University Hospital Graz
- Department Name
- University Clinic for Internal Medicine Clinical Department of Gastroenterology and Hepatology
- Principal Investigator Name
- Andreas Blesl
- Principal Investigator Email
- andreas.blesl@medunigraz.at
- Contact Person Name
- Andreas Blesl
- Contact Person Email
- andreas.blesl@medunigraz.at
- Site Name
- Klinikum Wels-Grieskirchen GmbH
- Department Name
- Department of Internal Medicine I
- Principal Investigator Name
- Harald Hofer
- Principal Investigator Email
- harald.hofer@klinikum-wegr.at
- Contact Person Name
- Harald Hofer
- Contact Person Email
- harald.hofer@klinikum-wegr.at
- Site Name
- Medical University Of Vienna
- Department Name
- University Clinic for Internal Medicine III Level 7, 7i, Room J blue
- Principal Investigator Name
- Philipp Schreiner
- Principal Investigator Email
- philipp.schreiner@meduniwien.ac.at
- Contact Person Name
- Philipp Schreiner
- Contact Person Email
- philipp.schreiner@meduniwien.ac.at
Netherlands
- Latest Decision Or Authorization Date
- 15-01-2026
- Number Of Sites
- 3
- Number Of Participants
- 12
Sites
- Site Name
- Radboud universitair medisch centrum / RADBOUDUMC
- Department Name
- Maag,- darm,- leverziekten
- Principal Investigator Name
- Yasmijn van Heerwaarden
- Principal Investigator Email
- yasmijn.vanherwaarden@radboudumc.nl
- Contact Person Name
- Yasmijn van Heerwaarden
- Contact Person Email
- yasmijn.vanherwaarden@radboudumc.nl
- Site Name
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Department Name
- Department of Gastroenterology and Hepatology
- Principal Investigator Name
- Peter Siersema
- Principal Investigator Email
- p.siersema@erasmusmc.nl
- Contact Person Name
- Peter Siersema
- Contact Person Email
- p.siersema@erasmusmc.nl
- Site Name
- Amsterdam UMC Stichting
- Department Name
- Afd. Motiliteit PK1 Y 114
- Principal Investigator Name
- Arjan Bredenoord
- Principal Investigator Email
- a.j.bredenoord@amsterdamumc.nl
- Contact Person Name
- Arjan Bredenoord
- Contact Person Email
- a.j.bredenoord@amsterdamumc.nl
Germany
- Latest Decision Or Authorization Date
- 16-01-2026
- Number Of Sites
- 1
- Number Of Participants
- 11
Sites
- Site Name
- Klinikum rechts der Isar der TU Muenchen AöR
- Department Name
- "Innere Medizin II Ambulanz,Studien Raum 20.0.7/8"
- Principal Investigator Name
- Simon Weidlich
- Principal Investigator Email
- simon.weidlich@mri.tum.de
- Contact Person Name
- Simon Weidlich
- Contact Person Email
- simon.weidlich@mri.tum.de
Czechia
- Latest Decision Or Authorization Date
- 15-01-2026
- Number Of Sites
- 2
- Number Of Participants
- 7
Sites
- Site Name
- Hepato-Gastroenterologie HK s.r.o.
- Principal Investigator Name
- Tomás Vaňásek
- Principal Investigator Email
- tomas.vanasek@hepato-gastro.com
- Contact Person Name
- Tomás Vaňásek
- Contact Person Email
- tomas.vanasek@hepato-gastro.com
- Site Name
- Fakultni Nemocnice Brno
- Department Name
- Interní gastroenterologická klinika,Endoskopické centrum, pavilon Z, 5. NP
- Principal Investigator Name
- Radek Kroupa
- Principal Investigator Email
- kroupa.radek@fnbrno.cz
- Contact Person Name
- Radek Kroupa
- Contact Person Email
- kroupa.radek@fnbrno.cz
Belgium
- Latest Decision Or Authorization Date
- 19-01-2026
- Number Of Sites
- 4
- Number Of Participants
- 10
Sites
- Site Name
- UZ Leuven
- Department Name
- Maag-, darm- en leverziekten
- Principal Investigator Name
- Tim Vanuytsel
- Principal Investigator Email
- tim.vanuytsel@uzleuven.be
- Contact Person Name
- Tim Vanuytsel
- Contact Person Email
- tim.vanuytsel@uzleuven.be
- Site Name
- Sint-Lucas General Hospital
- Department Name
- Gastroenterologie
- Principal Investigator Name
- Joris Semb
- Principal Investigator Email
- sys@regionsjaelland.dk
- Contact Person Name
- Joris Semb
- Contact Person Email
- sys@regionsjaelland.dk
- Site Name
- Antwerp University Hospital
- Department Name
- Gastro-enterologie en Hepatologie
- Principal Investigator Name
- Heiko De Schepper
- Principal Investigator Email
- heiko.deschepper@uza.be
- Contact Person Name
- Heiko De Schepper
- Contact Person Email
- heiko.deschepper@uza.be
- Site Name
- AZ Sint-Lucas & Volkskliniek
- Department Name
- Maag-, darm- en leverziekten
- Principal Investigator Name
- Frederik De Clerck
- Principal Investigator Email
- frederik.declerck@azstlucas.be
- Contact Person Name
- Frederik De Clerck
- Contact Person Email
- frederik.declerck@azstlucas.be
Slovakia
- Latest Decision Or Authorization Date
- 14-01-2026
- Number Of Sites
- 2
- Number Of Participants
- 16
Sites
- Site Name
- Endomed s.r.o.
- Department Name
- Outpatient gastroenterological care
- Principal Investigator Name
- Miroslav Fedurco
- Principal Investigator Email
- fedurco@endomed.sk
- Contact Person Name
- Miroslav Fedurco
- Contact Person Email
- fedurco@endomed.sk
- Site Name
- Univerzitna Nemocnica Martin
- Department Name
- Internal Clinic-Gastroenterology
- Principal Investigator Name
- Peter Bánovčín
- Principal Investigator Email
- pbanovcin@gmail.com
- Contact Person Name
- Peter Bánovčín
- Contact Person Email
- pbanovcin@gmail.com
Spain
- Latest Decision Or Authorization Date
- 19-01-2026
- Number Of Sites
- 9
- Number Of Participants
- 25
Sites
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- Alergologia
- Principal Investigator Name
- Rosa Maria Munoz Cano
- Principal Investigator Email
- rmunoz@clinic.cat
- Contact Person Name
- Rosa Maria Munoz Cano
- Contact Person Email
- rmunoz@clinic.cat
- Site Name
- University Hospital Virgen Del Rocio S.L.
- Department Name
- Alergologia
- Principal Investigator Name
- Maria del Robledo Avila Castellano
- Principal Investigator Email
- roavilacastellano@gmail.com
- Contact Person Name
- Maria del Robledo Avila Castellano
- Contact Person Email
- roavilacastellano@gmail.com
- Site Name
- Hospital Universitario Virgen De La Macarena
- Department Name
- Digestivo
- Principal Investigator Name
- Federico Arguelles Arias
- Principal Investigator Email
- farguelles@telefonica.net
- Contact Person Name
- Federico Arguelles Arias
- Contact Person Email
- farguelles@telefonica.net
- Site Name
- Hospital Universitario De Navarra
- Department Name
- Gastroenterologia
- Principal Investigator Name
- Oscar Nantes Castillejo
- Principal Investigator Email
- oscar.nantes.castillejo@navarra.es
- Contact Person Name
- Maria del Robledo Avila Castellano
- Contact Person Email
- oscar.nantes.castillejo@navarra.es
- Site Name
- Hospital General Universitario Gregorio Maranon
- Department Name
- Alergologia
- Principal Investigator Name
- Alicia Prieto Garcia
- Principal Investigator Email
- alicia.prieto@salud.madrid.org
- Contact Person Name
- Alicia Prieto Garcia
- Contact Person Email
- alicia.prieto@salud.madrid.org
- Site Name
- Hospital Universitario Infanta Leonor
- Department Name
- Digestivo
- Principal Investigator Name
- Raquel Garcia Sanchez
- Principal Investigator Email
- raquelgarsa@gmail.com
- Contact Person Name
- Raquel Garcia Sanchez
- Contact Person Email
- raquelgarsa@gmail.com
- Site Name
- Hospital General De Tomelloso
- Department Name
- Digestivo
- Principal Investigator Name
- Alfredo Lucendo Villarin
- Principal Investigator Email
- ajlucendo@hotmail.com
- Contact Person Name
- Alfredo Lucendo Villarin
- Contact Person Email
- ajlucendo@hotmail.com
- Site Name
- Vall D'hebron Institut De Recerca
- Department Name
- Alergologia
- Principal Investigator Name
- Mar Guilarte Clavero
- Principal Investigator Email
- mar.guilarte@vallhebron.cat
- Contact Person Name
- Mar Guilarte Clavero
- Contact Person Email
- mar.guilarte@vallhebron.cat
- Site Name
- Hospital Universitario De La Princesa
- Department Name
- Gastroenterologia
- Principal Investigator Name
- Cecilio Santander VAquero
- Principal Investigator Email
- cecilio.santander@salud.madrid.org
- Contact Person Name
- Cecilio Santander VAquero
- Contact Person Email
- cecilio.santander@salud.madrid.org
Greece
- Latest Decision Or Authorization Date
- 14-01-2026
- Number Of Sites
- 6
- Number Of Participants
- 21
Sites
- Site Name
- Ippokratio General Hospital Of Thessaloniki
- Department Name
- 4th Department of Internal Medicine
- Principal Investigator Name
- Ioannis Goulis
- Principal Investigator Email
- igoulis@gmail.com
- Contact Person Name
- Ioannis Goulis
- Contact Person Email
- igoulis@gmail.com
- Site Name
- University General Hospital Attikon
- Department Name
- Department of Dermatology and Venereology
- Principal Investigator Name
- Michael Makris
- Principal Investigator Email
- mmakris.allergy@gmail.com
- Contact Person Name
- Michael Makris
- Contact Person Email
- mmakris.allergy@gmail.com
- Site Name
- Athens Naval Hospital
- Department Name
- Department of Allergy
- Principal Investigator Name
- Fotios Psarros
- Principal Investigator Email
- psarros@allergy.gr
- Contact Person Name
- Fotios Psarros
- Contact Person Email
- psarros@allergy.gr
- Site Name
- 424 Military General Training Hospital
- Department Name
- Department of Allergy and Clinical Immunology
- Principal Investigator Name
- George Konstantinou
- Principal Investigator Email
- gnkonstantinou@gmail.com
- Contact Person Name
- George Konstantinou
- Contact Person Email
- gnkonstantinou@gmail.com
- Site Name
- Laiko General Hospital Of Athens
- Department Name
- Department of Allergology
- Principal Investigator Name
- Nikolaos Mikos
- Principal Investigator Email
- mikosnikos@gmail.com
- Contact Person Name
- Nikolaos Mikos
- Contact Person Email
- mikosnikos@gmail.com
- Site Name
- Thoracic General Hospital Of Athens I Sotiria
- Department Name
- Department of Allergy and Clinical Immunology
- Principal Investigator Name
- Ekaterini Syrigou
- Principal Investigator Email
- esyrigou@hotmail.com
- Contact Person Name
- Ekaterini Syrigou
- Contact Person Email
- esyrigou@hotmail.com
Norway
- Latest Decision Or Authorization Date
- 16-01-2026
- Number Of Sites
- 6
- Number Of Participants
- 23
Sites
- Site Name
- Universitetssykehuset Nord-Norge HF
- Department Name
- Medisinsk klinikk, seksjon for fordøyelsessykdommer
- Principal Investigator Name
- Rasmus Goll
- Principal Investigator Email
- Rasmus.Goll@unn.no
- Contact Person Name
- Rasmus Goll
- Contact Person Email
- Rasmus.Goll@unn.no
- Site Name
- Akershus University Hospital
- Department Name
- Gastromedisinsk avdeling
- Principal Investigator Name
- Marius Vinje
- Principal Investigator Email
- Marius.Vinje@ahus.no
- Contact Person Name
- Marius Vinje
- Contact Person Email
- Marius.Vinje@ahus.no
- Site Name
- Oslo University Hospital HF
- Department Name
- Pediatric Department
- Principal Investigator Name
- Gori Perminow
- Principal Investigator Email
- goeper@ous-hf.no
- Contact Person Name
- Gori Perminow
- Contact Person Email
- goeper@ous-hf.no
- Site Name
- Akershus University Hospital
- Department Name
- Barne- og Ungdomsklinikken
- Principal Investigator Name
- Christopher Stephen Inchley
- Principal Investigator Email
- Christopher.Stephen.Inchley@ahus.no
- Contact Person Name
- Christopher Stephen Inchley
- Contact Person Email
- Christopher.Stephen.Inchley@ahus.no
- Site Name
- Helse Moere Og Romsdal HF
- Department Name
- Deptartment of Medicine/ Deptartment of Clinical studies
- Principal Investigator Name
- Dag Arne Lihaug Hoff
- Principal Investigator Email
- Dag.Arne.Lihaug.Hoff@helse-mr.no
- Contact Person Name
- Dag Arne Lihaug Hoff
- Contact Person Email
- Dag.Arne.Lihaug.Hoff@helse-mr.no
- Site Name
- Oslo University Hospital HF
- Department Name
- Department of Gastroenterology
- Principal Investigator Name
- Margit Brottveit
- Principal Investigator Email
- uxarot@ous-hf.no
- Contact Person Name
- Margit Brottveit
- Contact Person Email
- uxarot@ous-hf.no
Sweden
- Latest Decision Or Authorization Date
- 14-01-2026
- Number Of Sites
- 2
- Number Of Participants
- 19
Sites
- Site Name
- Uppsala University Hospital
- Department Name
- Mag-tarmmottagningen, avdelning 65B Ingång 70, 1 trp, Akademiska Sjukhuset, Uppsala
- Principal Investigator Name
- Marie Carlsson
- Principal Investigator Email
- marie.carlson@akademiska.se
- Contact Person Name
- Marie Carlsson
- Contact Person Email
- marie.carlson@akademiska.se
- Site Name
- NU Hospital Group-Vaestra Goetalandsregionen
- Department Name
- NÄL, Öron-, Näs-, och Halskliniken, Lärketorpsvägen 20, 261 73 Trollhättan
- Principal Investigator Name
- Helen M. Larsson
- Principal Investigator Email
- helen.m.larsson@vgregion.se
- Contact Person Name
- Helen M. Larsson
- Contact Person Email
- helen.m.larsson@vgregion.se
Italy
- Latest Decision Or Authorization Date
- 09-04-2026
- Number Of Sites
- 9
- Number Of Participants
- 28
Sites
- Site Name
- Humanitas Research Hospital
- Department Name
- PERSONALIZED MEDICINE ASTHMA AND ALLERGY CENTER-RESPIRATORY DISEASES UNIT
- Principal Investigator Name
- Enrico Marco Heffler
- Principal Investigator Email
- enrico.heffler@hunimed.eu
- Contact Person Name
- Enrico Marco Heffler
- Contact Person Email
- enrico.heffler@hunimed.eu
- Site Name
- Azienda Ospedaliero Universitaria Pisana
- Department Name
- Gastroenterology department
- Principal Investigator Name
- Nicola De Bortoli
- Principal Investigator Email
- nicola.debortoli@unipi.it
- Contact Person Name
- Nicola De Bortoli
- Contact Person Email
- nicola.debortoli@unipi.it
- Site Name
- Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
- Department Name
- Internal medicine deprtament
- Principal Investigator Name
- Giovanni Barbara
- Principal Investigator Email
- giovanni.barbara@unibo.it
- Contact Person Name
- Giovanni Barbara
- Contact Person Email
- giovanni.barbara@unibo.it
- Site Name
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Department Name
- gastroenterology department
- Principal Investigator Name
- Antonio Gasbarrini
- Principal Investigator Email
- antonio.gasbarrini@unicatt.it
- Contact Person Name
- Antonio Gasbarrini
- Contact Person Email
- antonio.gasbarrini@unicatt.it
- Site Name
- Azienda Ospedaliero-Universitaria Policlinico Umberto I
- Department Name
- maternal and child health department
- Principal Investigator Name
- Salvatore Oliva
- Principal Investigator Email
- salvatore.oliva@uniroma1.it
- Contact Person Name
- Salvatore Oliva
- Contact Person Email
- salvatore.oliva@uniroma1.it
- Site Name
- ASST Grande Ospedale Metropolitano Niguarda
- Department Name
- Department of allergology and immulogy
- Principal Investigator Name
- Linda Borgonovo
- Principal Investigator Email
- marco.caminati@univr.it
- Contact Person Name
- Linda Borgonovo
- Contact Person Email
- marco.caminati@univr.it
- Site Name
- Azienda Ospedale-Universita Padova
- Department Name
- Department of Surgery and gastroenterology
- Principal Investigator Name
- Edoardo Vincenzo Savarino
- Principal Investigator Email
- edoardo.savarino@unipd.it
- Contact Person Name
- Edoardo Vincenzo Savarino
- Contact Person Email
- edoardo.savarino@unipd.it
- Site Name
- Centro Ricerche Cliniche Di Verona S.r.l.
- Department Name
- Allergology and Immunology Department
- Principal Investigator Name
- Marco Caminati
- Principal Investigator Email
- jan.schroeder@ospedaleniguarda.it
- Contact Person Name
- Marco Caminati
- Contact Person Email
- jan.schroeder@ospedaleniguarda.it
- Site Name
- Azienda Ospedaliera Universitaria Federico II Di Napoli
- Department Name
- Department of Clinical Medicine and Surgery
- Principal Investigator Name
- Giovanni Sarnelli
- Principal Investigator Email
- sarnelli@unina.it
- Contact Person Name
- Giovanni Sarnelli
- Contact Person Email
- sarnelli@unina.it
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 (EU marketing authorisation EU/1/22/1677/001)
- Starting Dose
- 210 mg
- Dose Levels
- 210 mg; 420 mg
- Frequency
- Every 4 weeks
- Maximum Dose
- 420 mg
- Dose Escalation Increase
- 210 mg and 420 mg
- Investigational Product Name
- Tezepelumab-placebo
- Modality
- Other
- Authorisation Status
- Not applicable
- Frequency
- Every 4 weeks (placebo Q4W)
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