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01
Overview
Phase 3, open-label, single-arm trial of dupilumab in asthma, sponsored by Sanofi. Primary endpoints: Treatment-emergent Adverse Events at 144 weeks and Treatment-emergent Adverse Event Rate at 144 weeks. Started Aug 2018; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Dupilumab
Dupilumab 300 mg SC q2w + Standard of Care
03
Who it enrols
Patients with moderate to severe asthma who completed the treatment period in the previous dupilumab clinical study TRAVERSE-LTS12551.
04
Endpoints
Primary
Treatment-emergent Adverse Events
Treatment-emergent Adverse Event Rate
Secondary
Adverse Events of Special Interest Rate
Treatment-emergent Serious Adverse Events
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