A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate Dupilumab in Patients With Moderate to Severe Uncontrolled Asthma

NCT01854047 Phase 2 COMPLETED Results posted

Primary Objective: To evaluate the efficacy of different doses and regimens of dupilumab in participants with moderate to severe uncontrolled asthma. Secondary Objective: To evaluate different doses and regimens of dupilumab in participants with moderate to severe uncontrolled asthma, with regard to: * Safety and tolerability * Dupilumab systemic exposure and anti-drug antibodies

Details

Lead sponsor	Sanofi
Phase	Phase 2
Status	COMPLETED
Enrolment	776
Start date	2013-06
Completion	2015-04

Conditions

• Asthma

Interventions

• Dupilumab
• placebo
• ICS/LABA therapy
• Salbutamol/albuterol
• Levosalbutamol/levalbuterol

Primary outcomes

• Absolute Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 12: High Eosinophils -Intent to Treat (HEos-ITT) Population — Baseline, Week 12
  FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.
• Absolute Change From Baseline in FEV1 at Week 12: ITT Population — Baseline, Week 12
  FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.

Countries

United States, Argentina, Australia, Chile, France, Italy, Japan, Mexico, New Zealand, Poland, Russia, South Africa, South Korea, Spain, Turkey (Türkiye), Ukraine