NCT01449162

Masitinib in Treatment of Patients With Severe Persistent Asthma Treated With Oral Corticosteroids

A Prospective, Multicenter, Randomised, Double-blind, Placebo-controlled, 2-parallel Groups, Phase 3 Study to Compare the Efficacy and the Safety of Masitinib at 6 mg/kg/Day Versus Placebo in the Treatment of Patients With Severe Persistent Asthma Treated With Oral Corticosteroids

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 420 (actual)
• Sponsor: AB Science · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The study objective is to compare the efficacy and the safety of masitinib at 6 mg/kg/day versus placebo in the treatment of patients with Severe Persistent Asthma treated with oral corticosteroids.

Detailed description

Masitinib is a selective tyrosine kinase inhibitor. It is known that activation of inflammatory cells, such as mast cells, and fibrous tissue remodeling are associated with c-Kit, Lyn and PDGFR kinase signaling pathways; all key targets of masitinib. The objective of this study is to compare the efficacy and safety of masitinib at 6 mg/kg/day versus matched placebo in severe persistent asthma patients that is uncontrolled with oral corticosteroids. The primary outcome measure will be severe asthma exacerbation rate over duration of the treatment.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	Masitinib	6 mg/kg/day
DRUG	Placebo

Timeline

• Start date: 2011-01-01
• Primary completion: 2019-11-01
• Completion: 2019-11-01
• First posted: 2011-10-10
• Last updated: 2021-02-10

Locations

8 sites across 6 countries: Bulgaria, Czechia, France, Hungary, India, Spain