NCT02573233

Evaluation of Dupilumab's Effects on Airway Inflammation in Patients With Asthma

An Exploratory, Double-blind, Placebo-controlled Study of the Effects of Dupilumab on Airway Inflammation of Adults With Persistent Asthma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Primary Objective: To evaluate the effect of dupilumab, compared to placebo, on airway inflammation in participants with persistent asthma. Secondary Objective: To assess the safety, tolerability, and immunogenicity of dupilumab compared to placebo.

Detailed description

The total study duration for each participant was between approximately 29 and maximum of 30 weeks, consisting of a screening period of 5 weeks and optional up to 7 additional days, a treatment period of 12 weeks, and a post-treatment period of 12 weeks. Participants who completed the treatment period could be eligible to participate in an open-label extension study.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	Placebo	Pharmaceutical form:solution Route of administration: subcutaneous
DRUG	Dupilumab SAR231893/REGN668	Pharmaceutical form:solution Route of administration: subcutaneous
DRUG	fluticasone propionate and salmeterol	Pharmaceutical form:inhalation aerosol, inhalation powder Route of administration: inhaled
DRUG	budesonide and formoterol	Pharmaceutical form:inhalation aerosol Route of administration: inhaled
DRUG	mometasone furoate and formoterol	Pharmaceutical form:inhalation aerosol Route of administration: inhaled

Timeline

• Start date: 2016-01-27
• Primary completion: 2018-01-03
• Completion: 2018-01-03
• First posted: 2015-10-09
• Last updated: 2022-04-04
• Results posted: 2019-01-28

Locations

16 sites across 6 countries: United States, Canada, Denmark, Germany, Sweden, United Kingdom

Regulatory

• FDA-regulated drug study