NCT02528214

Evaluation of Dupilumab in Patients With Severe Steroid Dependent Asthma

A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Dupilumab in Patients With Severe Steroid Dependent Asthma

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 210 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

Primary Objective: To evaluate the efficacy of dupilumab, compared with placebo, for reducing the use of maintenance oral corticosteroids (OCS) in participants with severe steroid-dependent asthma. Secondary Objectives: * To evaluate the safety and tolerability of dupilumab. * To evaluate the effect of dupilumab in improving participants-reported outcomes. * To evaluate dupilumab systemic exposure and the incidence of treatment-emergent antidrug antibodies.

Detailed description

The total study duration per participant was up to 46 weeks, consisting of a screening period of 3 to up to 8 weeks (up to 10 weeks for participants who experienced a clinically significant asthma exacerbation during the screening period), a randomized treatment period of up to 24 weeks, and a post-treatment period of 12 weeks. Participants who completed treatment were considered for eligibility into the long term extension study LTS12551 (NCT02134028).

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	Dupilumab	Solution for injection, Subcutaneous injection in the abdomen, upper thigh or upper arm.
DRUG	Placebo	Solution for injection, Subcutaneous injection in the abdomen, upper thigh or upper arm.
DRUG	Oral corticosteroid therapy (prednisone/prednisolone)	Oral administration.
DRUG	Inhaled corticosteroid (ICS) therapy	Oral inhalation, stable dose (high dose) of ICS in combination with up to 2 other controller medicines (second or third controller therapy).
DRUG	Albuterol/Salbutamol	Oral inhalation as needed.
DRUG	Levalbuterol/Levosalbutamol	Oral inhalation as needed.

Timeline

• Start date: 2015-10-15
• Primary completion: 2017-09-20
• Completion: 2017-11-13
• First posted: 2015-08-19
• Last updated: 2019-10-01
• Results posted: 2018-10-23

Locations

80 sites across 17 countries: United States, Argentina, Belgium, Brazil, Canada, Chile, Colombia, Hungary, Israel, Italy, Mexico, Netherlands, Poland, Romania, Russia, Spain, Ukraine