drugset / Trial / NCT03782532

Efficacy and Safety Study of Dupilumab in Patients With Persistent Asthma

NCT03782532

Phase 3 Completed 486 enrolled Sanofi Regeneron Pharmaceuticals · collab
RandomizedParallel-groupTriple-blindTreatment

Summary

Primary Objective: To evaluate the efficacy of dupilumab in patients with persistent asthma Secondary Objectives: * To evaluate the safety and tolerability of dupilumab * To evaluate the effect of dupilumab on improving patient reported outcomes including health related quality of life * To evaluate dupilumab systemic exposure and immunogenicity

Timeline

Start
2019-01-25
Primary completion
2022-05-21
Completion
2022-05-21

Drugs

EvaluationDrugModalityDoseRoute
Subject Dupilumab Monoclonal antibody 200 mg Subcutaneous
Background Prednisolone Other / unclassified Oral
Background Prednisone Other / unclassified Oral

Indications