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Tozorakimab in Symptomatic COPD with Exacerbation History (OBERON)
NCT05166889Phase 3
Key facts
- Status
- Completed
- Start
- Jan 2022
- Primary completion
- Jan 2026
- Countries
- 21
- Sponsor
- AstraZeneca
- Modality
- Monoclonal Antibodies
- Drugs
- tozorakimab
- Conditions
- chronic obstructive pulmonary disease (COPD)
01
Overview
Phase 3, randomised, double-blind trial of tozorakimab in chronic obstructive pulmonary disease (COPD) (3 arms), sponsored by AstraZeneca. Primary endpoint: Annualized rate of moderate to severe COPD exacerbations at 52 weeks. Started Jan 2022; status: completed.
02
Design
3 arms- Study design
- RandomizedDouble-blind
Tozorakimab Dose 1
Dosing subcutaneously tozorakimab Dose 1 and placebo
Tozorakimab Dose 2
Dosing subcutaneously tozorakimab Dose 2
Placebo
Dosing subcutaneously with equivalent volume to tozorakimab
03
Who it enrols
Adults >= 40 years with symptomatic COPD, history of exacerbations, on optimized inhaled therapy, with significant smoking history.
04
Endpoints
Primary
Annualized rate of moderate to severe COPD exacerbations
Secondary
Annualized rate of moderate to severe COPD exacerbations in former or current smokers
Time to first moderate to severe COPD exacerbation in former smokers
Mean change from baseline in pre-BD, pre-dose trough FEV1
Percentage of responders achieving MCID in E-RS:COPD total score
Mean change from baseline in E-RS:COPD total score
Percentage of responders achieving MCID in SGRQ total score
Mean change from baseline in SGRQ total score
Time to first severe COPD exacerbation in former smokers
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