Clinical trial NCT03771040: Masitinib in the Treatment of Patients With Severe Uncontrolled Asthma and Elevated Eosinophil Levels
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Keywords: Severe persistent asthma
Eosinophil
Tyrosine kinase inhibitor
Lead sponsor: AB Science
Sponsor class: INDUSTRY
First posted: 2018-12-10
Enrollment: 347
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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. 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Severe asthma exacerbation rate
timeFrame: Duration of patient treatment exposure, assessed until withdrawal from study, study completion date, or for a maximum of 60 months
Secondary outcomes:
measure: Asthma exacerbation rate
timeFrame: Duration of patient treatment exposure, assessed until withdrawal from study, study completion date, or for a maximum of 60 months
measure: Asthma Control Questionnaire (ACQ)
timeFrame: 48 weeks
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Centro Respiratorio Quilmes
city: Kuching
country: Malaysia
facility: Sarawak General Hospital
city: Miraflores
country: Peru
facility: Clínica Universidad de los Andes
city: Quezon City
country: Philippines
facility: The Philippine Heart Center
city: Kiev
country: Ukraine
facility: National institute of phthisiology and pulmonology named after F.G. Yanovsky NAMS of Ukraine
Study officials:
affiliation: University of Medicine and Pharmacy Oradea, Oradea, Romania.
name: Lavinia Davidescu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: