NCT03782532

Efficacy and Safety Study of Dupilumab in Patients With Persistent Asthma

A Randomized, Double Blind, Placebo-controlled, Parallel-group Phase 3 Study to Evaluate the Efficacy and Safety of Dupilumab in Patients With Persistent Asthma

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 486 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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

Detailed description

The total duration of study per patient is approximately 40 weeks, including 3 to 5 weeks of screening period, 24 weeks of treatment period and 12 weeks of post-treatment period.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	Dupilumab SAR231893	Pharmaceutical form: Solution Route of administration: Subcutaneous
DRUG	Placebo	Pharmaceutical form: Solution Route of administration: Subcutaneous
DRUG	Asthma Controller Therapies (include prednisone/prednisolone)	Pharmaceutical form: Aerosol, capsules, tablets, oral solution Route of administration: Inhalation, oral
DRUG	Asthma Reliever Therapies	Pharmaceutical form: Nebulized, aerosol Route of administration: Inhaled

Timeline

• Start date: 2019-01-25
• Primary completion: 2022-05-21
• Completion: 2022-05-21
• First posted: 2018-12-20
• Last updated: 2022-12-28

Locations

67 sites across 2 countries: China, India