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

Phase 3

Completed

• Conditions: Asthma
• Interventions: Drug: Placebo; Drug: Masitinib

• Registration Number: NCT01449162
• Lead Sponsor: AB Science

Brief 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.

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-10-06
• Study First Submitted QC: 2011-10-07
• Study First Posted: 2011-10-10
• Primary Completion: 2019-11
• Study Completion: 2019-11
• Disposition First Submitted: 2020-03-30
• Disposition First Submitted QC: 2020-03-30
• Disposition First Posted: 2020-04-03
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-09
• Last Update Posted: 2021-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 420

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo as add-on to oral corticosteroids	Placebo	Participants receive placebo (6 mg/kg/day), given orally twice daily, as add-on to oral corticosteroids
Masitinib as add-on to oral corticosteroids	Masitinib	Participants receive masitinib (6 mg/kg/day), given orally twice daily, as add-on to oral corticosteroids

Primary Outcome Measures

Name	Time	Method
Severe asthma exacerbation rate	Duration of patient treatment exposure, assessed until withdrawal from study, study completion date, or for a maximum of 60 months	The number of severe asthma exacerbations over time frame of outcome measure

Secondary Outcome Measures

Name	Time	Method
ACQ Score	36 weeks	Asthma Control Questionnaire (ACQ) Score
Asthma exacerbation rate	Duration of patient treatment exposure, assessed until withdrawal from study, study completion date, or for a maximum of 60 months	The number of asthma exacerbations over time frame of outcome measure

Trial Locations

Locations (8)

Hospital La Cavale Blanche; 🇫🇷 Brest, France

Hospital Polyclinic Melnik; 🇨🇿 Mělník, Czechia

l'Hopital Albert Calmette; 🇫🇷 Lille, France

l'Hopital de la Croix Rousse; 🇫🇷 Lyon, France

King George Hospital; 🇮🇳 Hyderabad, India

Hospital Universitario Doctor Peset; 🇪🇸 Valencia, Spain

Dr. Georgi Stranski University Hospital; 🇧🇬 Pleven, Bulgaria

University of Debrecen Medical and Health Science Center; 🇭🇺 Debrecen, Hungary