Masitinib in the Treatment of Patients With Severe Uncontrolled Asthma and Elevated Eosinophil Levels

Asthma Clinical Trial

Official title:

A Prospective, Multicenter, Randomised, Double-blind, Placebo-controlled, Phase 3 Study to Compare the Efficacy and the Safety of Masitinib Versus Placebo in the Treatment of Patients With Severe Uncontrolled Asthma and Elevated Eosinophil Levels

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03771040
• Other study ID #: AB14001
• Status: Completed
• Phase: Phase 3
• Start date: December 2016
• Est. completion date: September 2020

Study information

• Verified date: April 2020
• Source: AB Science
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the safety and efficacy of masitinib (6 mg/kg/day) in severe persistent asthma, uncontrolled with high dose of inhaled corticosteroid and with elevated eosinophil levels.

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. This is a multicenter, double-blind, randomized, parallel-group (ascending dose titration of masitinib to 6.0 mg/kg/day and matching placebo), comparative study of oral masitinib in the treatment of patients with severe asthma, uncontrolled with high dose of inhaled corticosteroid and with elevated eosinophil levels. Eligible patients will be treated during at least 48 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 347
• Est. completion date: September 2020
• Est. primary completion date: September 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Main inclusion criteria include:

• Patients with a physician diagnosis of persistent asthma for at least 12 months based on Global Initiative for Asthma (GINA) 2009 Guidelines whose asthma is partially controlled or uncontrolled on inhaled corticosteroids (ICS) / long-acting beta2-agonists (LABA) combination therapy.
• Patient with elevated eosinophil level related to asthma at baseline: =0.15 K/uL or patient with eosinophil level =0.15 K/uL related to asthma demonstrated in the year prior to screening
• Non-smoker patient for at least one year and with a prior tobacco consumption <10 packs/year

Main exclusion criteria include:

• Female patient who is pregnant or lactating
• Asthmatic patient still exposed to allergens or to triggering factors influencing asthma control
• Chronic obstructive pulmonary disease and/or other lung diseases impairing Pulmonary Function Tests
• Within 12 weeks prior to screening, patient who received oral corticosteroids for any other reason than to treat severe asthma exacerbation (patients needing long term corticosteroids intake to control basal asthma condition)
• Patient with history of acute infectious sinusitis or respiratory tract infection within 4 weeks prior to screening visit
• Patient with active lung disease other than asthma (e.g. chronic bronchitis)

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Masitinib

• Placebo

Locations

Country	Name	City	State
Argentina	Centro Respiratorio Quilmes	Buenos Aires
Malaysia	Sarawak General Hospital	Kuching
Peru	Clínica Universidad de los Andes	Miraflores
Philippines	The Philippine Heart Center	Quezon City
Ukraine	National institute of phthisiology and pulmonology named after F.G. Yanovsky NAMS of Ukraine	Kiev

Sponsors (1)

Lead Sponsor	Collaborator
AB Science

Countries where clinical trial is conducted

Argentina,  Malaysia,  Peru,  Philippines,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Severe asthma exacerbation rate	The number of severe asthma exacerbations over time frame of outcome measure	Duration of patient treatment exposure, assessed until withdrawal from study, study completion date, or for a maximum of 60 months
Secondary	Asthma exacerbation rate	The number of asthma exacerbations over time frame of outcome measure	Duration of patient treatment exposure, assessed until withdrawal from study, study completion date, or for a maximum of 60 months
Secondary	Asthma Control Questionnaire (ACQ)	Asthma Control Questionnaire (ACQ); Type of questionnaire-description: A simple questionnaire to measure the adequacy of asthma control and change in asthma control which occurs either spontaneously or as a result of treatment.; Number of items: 7 items; 1 week recall (for items on symptoms and rescue inhaler use); Number of domains & categories: ACQ has a multidimensional construct assessing symptoms (5 items--self-administred) and rescue inbronchodilator use (1 item-self-administered), and FEV1% (1 item) completed by clinic staff; Scaling of items: 7-point scale (0=no impairment, 6= maximum impairment for symptoms and rescue use; and 7 categories for FEV1%). Scores range between 0 (totally controlled) and 6 (severely uncontrolled).	48 weeks