Tests tozorakimab for uncontrolled asthma in adults using inhaled steroids
Tests tozorakimab injections against placebo in adults with uncontrolled asthma.
Plain-language title generated from the registry record
Registry title: Dose Range Finding Study to Assess Efficacy and Safety of Tozorakimab in Adults With Uncontrolled Asthma on Medium-to-High Dose Inhaled Corticosteroids
Key facts
- Where
- Fukuoka, Ginowan-shi, Hiroshima, Ishinomaki, Kawaguchi-shi, Kiyose-shi, Kobe, Meguro-ku, Miura, Neyagawa, Sapporo, Takamatsu, Ube, and Yokohama, JapanSee the 14 sites
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT06932263, who can take part
Where in Japan
- FukuokaFukuoka, JapanTaking people
- Ginowan-shiGinowan-shi, JapanTaking people
- HiroshimaHiroshima, JapanTaking people
- IshinomakiIshinomaki, JapanTaking people
- Kawaguchi-shiKawaguchi-shi, JapanTaking people
- Kiyose-shiKiyose-shi, JapanTaking people
- KobeKobe, JapanTaking people
- Meguro-kuMeguro-ku, JapanTaking people
- MiuraMiura, JapanTaking people
- NeyagawaNeyagawa, JapanTaking people
- SapporoSapporo, JapanTaking people
- TakamatsuTakamatsu, JapanTaking people
- UbeUbe, JapanTaking people
- YokohamaYokohama, JapanTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- AstraZeneca
- Trial code
- NCT06932263EU 2024-519116-14-00
- Record updated
- 30 October 2026
- Original description
This is a dose-range finding, double-blind, placebo-controlled, phase IIb study designed to assess efficacy and safety of tozorakimab administered subcutaneously in adult participants with uncontrolled asthma receiving medium-to-high dose inhaled corticosteroids.Read full original descriptionShow less
A Phase IIb, Multicentre, Double-blind, Placebo-controlled Dose Range Finding Study to Assess Efficacy and Safety of Tozorakimab in Adult Participants With Uncontrolled Asthma on Medium-to High Dose Inhaled Corticosteroids
This is a dose-range finding, double-blind, placebo-controlled, phase IIb study designed to assess efficacy and safety of tozorakimab administered subcutaneously in adult participants with uncontrolled asthma receiving medium-to-high dose inhaled corticosteroids.
Inclusion: Provision of signed and dated written informed consent prior to any study-specific procedures; Adults aged 18-75, inclusive when signing the informed consent; Documented physician-diagnosis of asthma for at least 12 months; Treated with medium or high dose ICS in combination with LABA; Demonstration of uncontrolled asthma through ACQ-6 score ≥ 1.5 ; Pre-bronchodilator FEV1 ≥ 40% to ≤ 90% of predicted normal; Documented exacerbation history in the last 12 months and biomarker requirements of:; ≥ 2 severe exacerbations OR; 1 severe exacerbation and:; (i) Eosinophils ≥ 150 cells/µl or (ii) FeNo ≥ 25 ppb; Participants need to demonstrate a ≥70% compliance for Asthma Daily Diary; Women of Child Bearing Potential (WOCBP) must have a negative pregnancy test; Contraceptive use by males and females should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Exclusion: Completed treatment for respiratory infection with antibiotics in the 4 weeks prior to Visit 1; Clinically significant pulmonary disease other than asthma ; Clinically significant aortic stenosis or pulmonary arterial hypertension; Active tuberculosis, hepatitis, HIV, or current diagnosis of cancer or immune complex disease; Unstable cardiovascular disorders; Current smokers, former smokers with >10 pack-years history.