Clinical trial • Phase II • Respiratory
TOZORAKIMAB for Asthma
Phase II trial of TOZORAKIMAB for Asthma.
Overview
- Trial Therapeutic Area
- Respiratory
- Trial Disease
- Asthma
- Trial Stage
- Phase II
- Drug Modality
- Monoclonal antibody | Small molecule
Key dates
- Initial CTIS Submission Date
- 23-01-2025
- First CTIS Authorization Date
- 03-04-2025
Trial design
Randomised, placebo arm (placebo arm: patients will receive placebo). background therapy: participants remain on medium-to-high dose ics in combination with laba (per gina 2024); no active comparator dose/schedule stated for investigational product.-controlled Phase II trial across 30 sites in France, Italy, Greece and others.
- Randomised
- Yes
- Comparator
- Placebo arm (Placebo Arm: Patients will receive placebo). Background therapy: participants remain on medium-to-high dose ICS in combination with LABA (per GINA 2024); no active comparator dose/schedule stated for investigational product.
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 470
- Trial Duration For Participant
- 448
Eligibility
Recruits 470 isVulnerablePopulationSelected is true. Informed consent: "Provision of signed and dated written informed consent prior to any study-specific procedures." Participants are adults (18-75) so assent for minors is not applicable. Optional genetic research requires separate signed consent. Subject information and ICF documents (including versions for pregnant partners and optional genomic consent) are provided for participating countries..
- Pregnancy Exclusion
- 10. Women of Child Bearing Potential (WOCBP) must have a negative serum pregnancy test at the Screening Visit and a negative urine pregnancy test prior to randomisation.
- Vulnerable Population
- isVulnerablePopulationSelected is true. Informed consent: "Provision of signed and dated written informed consent prior to any study-specific procedures." Participants are adults (18-75) so assent for minors is not applicable. Optional genetic research requires separate signed consent. Subject information and ICF documents (including versions for pregnant partners and optional genomic consent) are provided for participating countries.
Inclusion criteria
- {"criterion_text":"- 1. Provision of signed and dated written informed consent prior to any study-specific procedures."}
- {"criterion_text":"- 10. Women of Child Bearing Potential (WOCBP) must have a negative serum pregnancy test at the Screening Visit and a negative urine pregnancy test prior to randomisation."}
- {"criterion_text":"- 11. Contraceptive use by males and females should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies."}
- {"criterion_text":"- 2. Optional: Provision of signed and dated written Optional Genetic Research Information informed consent before the sample collection or optional genetic research that supports the Genomic Initiative."}
- {"criterion_text":"- 3. Adults aged 18-75, inclusive when signing the informed consent at Visit 1."}
- {"criterion_text":"- 4. Documented physician-diagnosis of asthma for at least 12 months prior to V1."}
- {"criterion_text":"- 5. Treated with medium or high dose ICS (as per GINA 2024 report) in combination with LABA."}
- {"criterion_text":"- 6. Demonstration of uncontrolled asthma through ACQ-6 score ≥ 1.5 at screening and randomisation."}
- {"criterion_text":"- 7. Pre-bronchodilator FEV1 ≥ 40% to ≤ 90% of predicted normal at both screening and randomisation."}
- {"criterion_text":"- 8. Documented exacerbation history in the last 12 months before screening and biomarker requirements of: (a) 2 severe exacerbations OR (b) 1 severe exacerbation and: (i) Eosinophils ≥ 150 cells/μl at screening or (ii) FeNo ≥ 25 ppb at screening and randomisation (Visits 1 and 2)"}
- {"criterion_text":"- 9. Participants need to demonstrate a ≥70% compliance for Asthma Daily Diary."}
Exclusion criteria
- {"criterion_text":"- 1. Completed treatment for respiratory infection with antibiotics in the 4 weeks prior to Visit 1."}
- {"criterion_text":"- 2. Clinically significant pulmonary disease other than asthma."}
- {"criterion_text":"- 3. Current smokers, former smokers with >10 pack-years history, or former smokers who stopped smoking <6 months before Visit 1."}
- {"criterion_text":"- 4. Clinically significant aortic stenosis or pulmonary arterial hypertension."}
- {"criterion_text":"- 5. Active tuberculosis, hepatitis, HIV, or current diagnosis of cancer or immune complex disease."}
- {"criterion_text":"- 6. Unstable cardiovascular disorders."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Annualised rate of severe asthma exacerbations.","definition_or_measurement_approach":""}
Secondary endpoints
- {"endpoint_text":"- 1. Annualised rate of severe asthma exacerbations (in participants with uncontrolled moderate-to-severe asthma and baseline eosinophils <300 cells/μL and history of ≥2 exacerbations within 12 months prior to screening).","definition_or_measurement_approach":"Annualised rate in the specified subgroup (baseline eosinophils <300 cells/μL and history of ≥2 exacerbations in prior 12 months)."}
- {"endpoint_text":"- 2. Time-to-first severe asthma exacerbation.","definition_or_measurement_approach":"Time-to-event analysis measuring time from randomisation to first severe asthma exacerbation."}
- {"endpoint_text":"- 3. Change from baseline in pre-bronchodilator forced expiratory volume in 1 second (FEV1) over weeks 20-26.","definition_or_measurement_approach":"Change from baseline in pre-bronchodilator FEV1 measured during weeks 20-26."}
- {"endpoint_text":"- 4. Change from baseline in post-bronchodilator FEV1 at week 26.","definition_or_measurement_approach":"Change from baseline in post-bronchodilator FEV1 measured at week 26."}
- {"endpoint_text":"- 5. Change from baseline in ACQ-6 at week 26.","definition_or_measurement_approach":"Change from baseline in ACQ-6 score measured at week 26."}
- {"endpoint_text":"- 6. Change from baseline in AQLQ(S)+12 at week 26.","definition_or_measurement_approach":"Change from baseline in AQLQ(S)+12 score measured at week 26."}
- {"endpoint_text":"- 7. Trough serum concentrations of tozorakimab over 52 weeks treatment period.","definition_or_measurement_approach":"Trough (pre-dose) serum concentration measurements of tozorakimab collected over the 52-week treatment period."}
- {"endpoint_text":"- 8. Anti-drug antibody (ADA) prevalence, incidence, and titre.","definition_or_measurement_approach":"Assessment of ADA prevalence, incidence and titre from immunogenicity assays."}
Recruitment
- Planned Sample Size
- 470
- Recruitment Window Months
- 35
- Consent Approach
- Adults (18-75) provide signed and dated written informed consent prior to any study-specific procedures. Separate optional consent is required for optional genetic/genomic research. Subject information and informed consent forms (L1 SIS and ICF) are provided in multiple country-specific versions/languages (documents listed for ES, GR, HU, FR and other localised versions). Pregnant partner information is available as a separate ICF document.
Methods
- K1_Recruitment arrangements (documented recruitment arrangements uploaded per country)
- K2_Recruitment material_Poster (study posters for recruitment)
- K3_Recruitment material_PrimayCare_Spain (primary care recruitment material for Spain)
- JLC recruitment materials / information to EC (country-specific recruitment packages listed in documents)
Geography
- Total Number Of Sites
- 30
- Total Number Of Participants
- 70
France
- Earliest CTIS Part Ii Submission Date
- 28-03-2025
- Latest Decision Or Authorization Date
- 14-01-2026
- Processing Time Days
- 292
- Number Of Sites
- 7
- Number Of Participants
- 12
Sites
- Site Name
- Centre Hospitalier Regional Et Universitaire De Brest
- Department Name
- Service de Pneumologie
- Contact Person Name
- Raphael Le Mao
- Contact Person Email
- raphael.lemao@chu-brest.fr
- Site Name
- Centre Hospitalier Regional De Marseille
- Department Name
- Clinique des Bronches Allergie et Sommeil -CHU Nord
- Contact Person Name
- Marion Gouitaa
- Contact Person Email
- marion.gouitaa@ap-hm.fr
- Site Name
- Centre Hospitalier Intercommunal Creteil
- Department Name
- Pneumologie
- Contact Person Name
- Amel Boudjemaa
- Contact Person Email
- amel.boudjemaa@chicreteil.fr
- Site Name
- Hospital Foch
- Department Name
- Department of pneumology
- Contact Person Name
- Colas Tcherakian
- Contact Person Email
- c.tcherakian@hopital-foch.com
- Site Name
- Centre Hospitalier Universitaire De Bordeaux
- Department Name
- Clinical investigation of pulmonary center
- Contact Person Name
- Pierre Olivier Girodet
- Contact Person Email
- pierre-olivier.girodet@chu-bordeaux.fr
- 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
- Les Hopitaux Universitaires De Strasbourg
- Department Name
- Service de Pneumologie
- Contact Person Name
- Naji Khayat
- Contact Person Email
- naji.khayath@chru-strasbourg.fr
Italy
- Earliest CTIS Part Ii Submission Date
- 06-03-2025
- Latest Decision Or Authorization Date
- 19-01-2026
- Processing Time Days
- 319
- Number Of Sites
- 4
- Number Of Participants
- 8
Sites
- Site Name
- IRCCS Ospedale Policlinico San Martino
- Department Name
- Respiratory System Diseases and Allergy
- Contact Person Name
- Fulvio Braido
- Contact Person Email
- fulvio.braido@unige.it
- Site Name
- Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
- Department Name
- UOC Pneumology
- Contact Person Name
- Claudia Crimi
- Contact Person Email
- claudia.crimi@unict.it
- Site Name
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Department Name
- UOSD allergology
- Contact Person Name
- Cristiano Caruso
- Contact Person Email
- cristiano.caruso@policlinicogemelli.it
- Site Name
- Azienda Ospedaliero Universitaria Ospedali Riuniti
- Department Name
- S.C. Malattie Apparato Respiratorio Universitaria
- Contact Person Name
- Giulia Scioscia
- Contact Person Email
- giulia.scioscia@unifg.it
Greece
- Earliest CTIS Part Ii Submission Date
- 24-03-2025
- Latest Decision Or Authorization Date
- 14-01-2026
- Processing Time Days
- 296
- Number Of Sites
- 6
- Number Of Participants
- 16
Sites
- Site Name
- Athens Medical Center S.A.
- Department Name
- Department of Sleep Apnea Study Pulmonology Laboratory
- Contact Person Name
- Dimosthenis Papapetrou
- Contact Person Email
- dimospapapetroudsa@hotmail.com
- Site Name
- General University Hospital Of Patras
- Department Name
- Department of Respiratory Medicine
- Contact Person Name
- Argyrios Tzouvelekis
- Contact Person Email
- argyris.tzouvelekis@gmail.com
- Site Name
- Athens Naval Hospital
- Department Name
- Pulmonary Clinic
- Contact Person Name
- Nikolaos Zias
- Contact Person Email
- nikoszias@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
- Thermi Clinic S.A.
- Department Name
- Internal Medicine Dpt
- Contact Person Name
- Stavros Tryfon
- Contact Person Email
- stavrostryfon@yahoo.gr
- Site Name
- Geniko Nosokomeio Thessalonikis George Papanikolaou
- Department Name
- University Pulmonary Clinic
- Contact Person Name
- Konstantinos Porpodis
- Contact Person Email
- kporpodis@yahoo.gr
Spain
- Earliest CTIS Part Ii Submission Date
- 19-03-2025
- Latest Decision Or Authorization Date
- 19-01-2026
- Processing Time Days
- 306
- Number Of Sites
- 6
- Number Of Participants
- 14
Sites
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Neumology
- Contact Person Name
- Iñigo Ojanguren Arranz
- Contact Person Email
- inigo.ojanguren@vallhebron.cat
- Site Name
- Hospital Del Mar
- Department Name
- Neumology
- Contact Person Name
- Maria Pilar Ausin Herrero
- Contact Person Email
- mpausin@parcdesalutmar.cat
- Site Name
- Hospital Universitario Virgen De La Victoria
- Department Name
- Neumology
- Contact Person Name
- Jose Luis Velasco Garrido
- Contact Person Email
- jlvelascogarrido@hotmail.com
- Site Name
- Hospital Universitario Marques De Valdecilla
- Department Name
- Neumology
- Contact Person Name
- Juan Luis Garcia Rivero
- Contact Person Email
- jgarcianml@gmail.com
- Site Name
- Hospital Universitario Dr Peset Aleixandre
- Department Name
- Neumology
- Contact Person Name
- Eva Martinez Moragon
- Contact Person Email
- evamartinezmoragon@gmail.com
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Alergology
- Contact Person Name
- Ismael Garcia Moguel
- Contact Person Email
- ismaelgmoguel@gmail.com
Hungary
- Earliest CTIS Part Ii Submission Date
- 10-03-2025
- Latest Decision Or Authorization Date
- 16-01-2026
- Processing Time Days
- 312
- Number Of Sites
- 7
- Number Of Participants
- 20
Sites
- Site Name
- Obudai Egeszseguegyi Centrum Kft.
- Contact Person Name
- Zsófia Ajtay
- Contact Person Email
- zsofia.ajtay@oec.hu
- Site Name
- Balassagyarmati Dr. Kenessey Albert Korhaz Rendelointezet
- Department Name
- Pulmonológia Krónikus Osztály
- Contact Person Name
- Magdolna Póczi
- Contact Person Email
- magdolnapoczi@gmail.com
- Site Name
- Infer-Med Kft.
- Contact Person Name
- Márta Papp
- Contact Person Email
- drpappm@gmail.com
- Site Name
- University Of Debrecen
- Department Name
- Tüdőgyógyászati Klinika
- Contact Person Name
- Ildikó Kissné Horváth
- Contact Person Email
- horvath.ildiko@med.unideb.hu
- Site Name
- Orszagos Koranyi Pulmonologiai Intezet
- Department Name
- Asthma Ambulancia
- Contact Person Name
- Zsuzsanna Csoma
- Contact Person Email
- csoma@koranyi.hu
- Site Name
- Reformatus Pulmonologiai Centrum
- Contact Person Name
- Edit Dulka
- Contact Person Email
- dulkaedit@gmail.com
- Site Name
- Erzsebet Gondozohaz Kft.
- Contact Person Name
- János Mucsi
- Contact Person Email
- mucsitrial@gmail.com
Sponsor
Primary sponsor
- Full Name
- AstraZeneca AB
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Sweden
Investigational products
- Investigational Product Name
- Tozorakimab
- Active Substance
- TOZORAKIMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- SUBCUTANEOUS INJECTION
- Route
- SUBCUTANEOUS INJECTION
- Investigational Product Name
- Tozorakimab-placebo
- Modality
- Other
- Combination Treatment
- Yes
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