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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Asthma

Intervention / Treatment
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* Drug: Masitinib
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Main inclusion criteria: Patient with severe asthma and already treated with oral corticosteroids at a minimal daily dose of 7.5 mg prednisone or equivalent for at least 3 months prior to screening visit Patient treated with oral corticosteroids during at least one period of 21 days, from 1 year prior to screening to 3 months before screening Patient with no significant change in the regular asthma medication, no severe asthma exacerbation for at least 4 weeks prior to screening visit Non-smoker patient for at least 1 year and with a prior tobacco consumption < 10 packs/year Main exclusion criteria: Patient with active lung disease other than asthma (e.g. chronic bronchitis) Female patient who is pregnant or lactating Asthmatic patient still exposed to allergens or to triggering factors influencing asthma control Patient with history of acute infectious sinusitis or respiratory tract infection within 4 weeks prior to screening visit

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Masitinib as add-on to oral corticosteroids<br>Participants receive masitinib (6 mg/kg/day), given orally twice daily, as add-on to oral corticosteroids | Drug: Masitinib<br>* 6 mg/kg/day<br>* Other names: AB1010;|
| Placebo Comparator: Placebo as add-on to oral corticosteroids<br>Participants receive placebo (6 mg/kg/day), given orally twice daily, as add-on to oral corticosteroids | Drug: Placebo<br> <br> * Other names: Placebo Oral Tablet;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| ACQ Score | Asthma Control Questionnaire (ACQ) Score | 36 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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severe persistent asthma, tyrosine kinase inhibitor