Informations générales (source: ClinicalTrials.gov)
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
Interventional
Phase 2
AstraZeneca (Voir sur ClinicalTrials)
mars 2025
mars 2028
02 octobre 2025
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CHI DE CRETEIL | AMEL BOUDJEMAA | 28/08/2025 16:45:04 | Contacter | ||
Critères
Tous
1. Provision of signed and dated written informed consent prior to any study-specific
procedures.
2. Adults aged 18-75, inclusive when signing the informed consent.
3. Documented physician-diagnosis of asthma for at least 12 months.
4. Treated with medium or high dose ICS in combination with LABA.
5. Demonstration of uncontrolled asthma through ACQ-6 score ≥ 1.5 .
6. Pre-bronchodilator FEV1 ≥ 40% to ≤ 90% of predicted normal.
7. Documented exacerbation history in the last 12 months and biomarker requirements of:
1. 2 severe exacerbations OR
2. 1 severe exacerbation and:
(i) Eosinophils ≥ 150 cells/µl or (ii) FeNo ≥ 25 ppb
8. Participants need to demonstrate a ≥70% compliance for Asthma Daily Diary.
9. Women of Child Bearing Potential (WOCBP) must have a negative pregnancy test.
10. Contraceptive use by males and females should be consistent with local regulations
regarding the methods of contraception for those participating in clinical studies.
Exclusion Criteria:
1. Completed treatment for respiratory infection with antibiotics in the 4 weeks prior
to Visit 1.
2. Clinically significant pulmonary disease other than asthma .
3. Current smokers, former smokers with >10 pack-years history.
4. Clinically significant aortic stenosis or pulmonary arterial hypertension.
5. Active tuberculosis, hepatitis, HIV, or current diagnosis of cancer or immune
complex disease.
6. Unstable cardiovascular disorders.