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Amlitelimab Long-term Extension Study in Moderate-to-severe Asthma
NCT06033833Phase 2
Key facts
- Status
- Terminated
- Start
- Sep 2023
- Primary completion
- Sep 2026
- Countries
- 14
- Sponsor
- Sanofi
- Modality
- Monoclonal Antibodies
- Drugs
- amlitelimab
- Conditions
- asthma
01
Overview
Phase 2, randomised, double-blind trial of amlitelimab in asthma (2 arms), sponsored by Sanofi. Primary endpoint: Percentage of participants with treatment-emergent adverse events at 156 weeks. Started Sep 2023; status: terminated.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Treatment group 1
Subcutaneous amlitelimab
Treatment group 2
Subcutaneous placebo
03
Who it enrols
Adult participants with moderate-to-severe asthma who completed the treatment period of the parent study, on background medium-to-high dose ICS therapy plus a second or third controller.
04
Endpoints
Primary
Percentage of participants with treatment-emergent adverse events
Secondary
Percentage of participants who experienced adverse events
Annualized rate of severe exacerbation events
Time to first exacerbation event
Annualized rate of severe asthma exacerbations requiring hospitalization or emergency room or urgent care visit
Change in pre-bronchodilator and post-bronchodilator forced expiratory volume in 1 second
Change in pre-bronchodilator and post-bronchodilator peak expiratory flow
Change in pre-bronchodilator and post-bronchodilator forced vital capacity
Change in pre-bronchodilator and post-bronchodilator forced expiratory flow 25% to 75%
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